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How to explain physician compounding to legislators

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Mon, 01/14/2019 - 10:04

 

In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.

[polldaddy:9779752]

The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.

The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.

We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.

What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.

First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.

Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.

Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.

Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.

A simple summary is – less pain, less cost – and no history of infections or complications.

It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.

If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com

Coldiron_Brett_OHIO_web.jpg
Dr. Brett M. Coldiron
pounding.

This column was updated June 22, 2017. 

 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.

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In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.

[polldaddy:9779752]

The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.

The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.

We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.

What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.

First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.

Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.

Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.

Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.

A simple summary is – less pain, less cost – and no history of infections or complications.

It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.

If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com

Coldiron_Brett_OHIO_web.jpg
Dr. Brett M. Coldiron
pounding.

This column was updated June 22, 2017. 

 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.

 

In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.

[polldaddy:9779752]

The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.

The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.

We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.

What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.

First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.

Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.

Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.

Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.

A simple summary is – less pain, less cost – and no history of infections or complications.

It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.

If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com

Coldiron_Brett_OHIO_web.jpg
Dr. Brett M. Coldiron
pounding.

This column was updated June 22, 2017. 

 

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.

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Best Practices: Protecting Dry Vulnerable Skin with CeraVe® Healing Ointment

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Thu, 06/20/2019 - 13:10
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Best Practices: Protecting Dry Vulnerable Skin with CeraVe® Healing Ointment

A supplement to Dermatology News. This advertising supplement is sponsored by Valeant Pharmaceuticals.

Topics

  • Reinforcing the Skin Barrier
  • NEA Seal of Acceptance
  • A Preventative Approach to Dry, Cracked Skin
  • CeraVe Ointment in the Clinical Setting

Faculty/Faculty Disclosure

Sheila Fallon Friedlander, MD 
Professor of Clinical Dermatology & Pediatrics 
Director, Pediatric Dermatology Fellowship Training Program 
University of California at San Diego School of Medicine 
Rady Children’s Hospital, 
San Diego, California

Dr. Friedlander was compensated for her participation in the development of this article.

CeraVe is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

 

Click here to read the supplement

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A supplement to Dermatology News. This advertising supplement is sponsored by Valeant Pharmaceuticals.

Topics

  • Reinforcing the Skin Barrier
  • NEA Seal of Acceptance
  • A Preventative Approach to Dry, Cracked Skin
  • CeraVe Ointment in the Clinical Setting

Faculty/Faculty Disclosure

Sheila Fallon Friedlander, MD 
Professor of Clinical Dermatology & Pediatrics 
Director, Pediatric Dermatology Fellowship Training Program 
University of California at San Diego School of Medicine 
Rady Children’s Hospital, 
San Diego, California

Dr. Friedlander was compensated for her participation in the development of this article.

CeraVe is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

 

Click here to read the supplement

A supplement to Dermatology News. This advertising supplement is sponsored by Valeant Pharmaceuticals.

Topics

  • Reinforcing the Skin Barrier
  • NEA Seal of Acceptance
  • A Preventative Approach to Dry, Cracked Skin
  • CeraVe Ointment in the Clinical Setting

Faculty/Faculty Disclosure

Sheila Fallon Friedlander, MD 
Professor of Clinical Dermatology & Pediatrics 
Director, Pediatric Dermatology Fellowship Training Program 
University of California at San Diego School of Medicine 
Rady Children’s Hospital, 
San Diego, California

Dr. Friedlander was compensated for her participation in the development of this article.

CeraVe is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

 

Click here to read the supplement

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Time Warp: Fax Machines Still Common in Oncology Practice. Why?

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On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

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On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

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Why?</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology.</span> </p> <p>One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. <br/><br/>“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”<br/><br/>Dr. Lewis, who has <a href="https://twitter.com/marklewismd/status/1775583962490171637">posted about his frustration</a> with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. <br/><br/>According to a <a href="https://www.healthit.gov/sites/default/files/page/2021-03/Hospital%20Use%20of%20Certified%20HIT_Interop%20v10_1.pdf">2021 report</a> by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. <br/><br/>Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. <br/><br/>“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” <br/><br/>If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.<br/><br/>Or is it?<br/><br/>Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. <br/><br/>“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”<br/><br/>And when information is lost, patient care can be compromised. </p> <h2>Slower Workflows, Care Concerns</h2> <p>Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. </p> <p>Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. <br/><br/>“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” <br/><br/>Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. <br/><br/>Insurers and third-party laboratories often send test results back by fax as well.<br/><br/>“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.<br/><br/>“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”<br/><br/>Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. <br/><br/>As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the <a href="https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html">Privacy Rule</a> also requires that data remain secure while at rest, which isn’t always possible, he added. <br/><br/>“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” <br/><br/>Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. <br/><br/>Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. <br/><br/>“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. <br/><br/>Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. <br/><br/>“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”</p> <h2>Broader Health Policy Impacts</h2> <p>The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. </p> <p>Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.<br/><br/><a href="https://academic.oup.com/jamia/article/29/8/1391/6594317?login=false">Studies show</a> that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.<br/><br/>Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. <br/><br/>“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. <br/><br/>Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. <br/><br/>“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”<br/><br/>But, she said, “we didn’t have the level of systems in place to do it well.”<br/><br/>Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. <br/><br/>Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.<br/><br/>“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” </p> <h2>Slow, but Steady, Improvements</h2> <p>Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.</p> <p>Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. <a href="https://mhcc.maryland.gov/mhcc/pages/hit/hit_hie/hit_hie.aspx">Maryland</a> is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.<br/><br/>According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are <a href="https://www.law.cornell.edu/regulations/maryland/COMAR-10-37-07-03">required to electronically connect</a> to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. <br/><br/>The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US <a href="https://www.gao.gov/assets/gao-23-105540.pdf">Government Accountability Office (GAO) report</a>. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.<br/><br/>Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s <a href="https://www.cdc.gov/surveillance/data-modernization/index.html">Data Modernization Initiative</a> is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. <br/><br/>Meanwhile, in March 2024, the Biden-Harris administration <a href="https://www.whitehouse.gov/ostp/news-updates/2024/03/05/improving-cancer-care-through-better-electronic-health-records-voluntary-commitments-and-call-to-action/">launched</a> United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. <br/><br/>EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. <br/><br/>“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”<br/><br/>Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. <br/><br/>But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” <br/><br/>“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/time-warp-fax-machines-still-common-oncology-practice-why-2024a1000c6q">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Cancer Drug Shortages Continue in the US, Survey Finds

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Wed, 07/03/2024 - 09:52

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

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Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

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Denlinger, MD, said in an interview.<br/><br/>The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/992943">shortage in 2023</a></span>, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.<br/><br/>“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.<br/><br/>However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.<br/><br/>“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.<br/><br/>In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.<br/><br/>Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).<br/><br/>In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.<br/><br/>In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.<br/><br/>Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.<br/><br/>How are centers dealing with ongoing supply issues?<br/><br/>Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.<br/><br/>“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.<br/><br/>Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.<br/><br/>The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.<br/><br/>“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/cancer-drug-shortages-continue-us-survey-finds-2024a1000bz8">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Survey Highlights Real-World Use of Upadacitinib in Adults With Atopic Dermatitis

Article Type
Changed
Tue, 07/02/2024 - 16:18

In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

ni
Dr. Jonathan I. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

[embed:render:related:node:268808]

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

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In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

ni
Dr. Jonathan I. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

[embed:render:related:node:268808]

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

ni
Dr. Jonathan I. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

[embed:render:related:node:268808]

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% rep</metaDescription> <articlePDF/> <teaserImage>302154</teaserImage> <teaser>Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch.</teaser> <title>Survey Highlights Real-World Use of Upadacitinib in Adults With Atopic Dermatitis</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">189</term> <term>203</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012a8f.jpg</altRep> <description role="drol:caption">Dr. Jonathan I. 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Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”<br/><br/>[[{"fid":"302154","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Jonathan I. Silverberg, professor of dermatology at George Washington University, Washington, DC","field_file_image_credit[und][0][value]":"Dr. Silverberg","field_file_image_caption[und][0][value]":"Dr. Jonathan I. Silverberg"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.<br/><br/>Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.<br/><br/></p> <h2>Improvements in Itch, Skin Clearance</h2> <p>Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.<br/><br/>After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.<br/><br/>In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.<br/><br/>“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”<br/><br/>He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”<br/><br/>AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/survey-spotlights-real-world-experience-upadacitinib-atopic-2024a1000bfu">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Small Melanoma In Situ: Single Center Study Finds Recurrence Low With 5-mm Margin Excisions

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Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorialJohn A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

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Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorialJohn A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

 

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorialJohn A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168615</fileName> <TBEID>0C050D91.SIG</TBEID> <TBUniqueIdentifier>MD_0C050D91</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240702T140216</QCDate> <firstPublished>20240702T151547</firstPublished> <LastPublished>20240702T151547</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240702T151547</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective ca</metaDescription> <articlePDF/> <teaserImage/> <teaser>“This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin,” the authors reported.</teaser> <title>Small Melanoma In Situ: Single Center Study Finds Recurrence Low With 5-mm Margin Excisions</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>21</term> <term>31</term> <term>15</term> </publications> <sections> <term canonical="true">39313</term> <term>27970</term> </sections> <topics> <term canonical="true">40695</term> <term>244</term> <term>203</term> <term>263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Small Melanoma In Situ: Single Center Study Finds Recurrence Low With 5-mm Margin Excisions</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Patients with small <span class="Hyperlink">melanoma</span> in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed</span>. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. </p> <p>“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamadermatol.2024.1878?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamadermatol.2024.1878">study</a></span>, which was published in <em>JAMA Dermatology</em>. “In addition, studies using the <span class="Hyperlink">Mohs micrographic surgery</span> technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”<br/><br/>To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.<br/><br/>The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by <span class="Hyperlink">lentigo</span> maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were &lt; 10 mm long and 88.9% were &lt; 10 mm wide. <br/><br/>Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.<br/><br/>Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. <br/><br/>In <span class="Hyperlink">Mohs surgery</span> studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (&lt; 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” <br/><br/>The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. <br/><br/>In an <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2820186?widget=personalizedcontent&amp;previousarticle=2820187">accompanying editorial</a></span>, <span class="Hyperlink">John A. Zitelli, MD</span>, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” <br/><br/>Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” <br/><br/><span class="Hyperlink">Hugh Greenway, MD</span>, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”<br/><br/>The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/excision-5-mm-margins-evaluated-small-melanoma-situ-2024a1000bw2">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Study Finds Variations in Pediatric Dermatologists Who Accept Medicaid

Article Type
Changed
Tue, 07/02/2024 - 15:29

 

TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

[embed:render:related:node:256264]

METHODOLOGY:

  • Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
  • They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

  • A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
  • Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
  • Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
  • Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

[embed:render:related:node:256264]

METHODOLOGY:

  • Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
  • They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

  • A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
  • Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
  • Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
  • Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

[embed:render:related:node:256264]

METHODOLOGY:

  • Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
  • They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

  • A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
  • Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
  • Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
  • Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168614</fileName> <TBEID>0C050D8E.SIG</TBEID> <TBUniqueIdentifier>MD_0C050D8E</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240702T144609</QCDate> <firstPublished>20240702T150803</firstPublished> <LastPublished>20240702T152424</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240702T150803</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Ed. by Deepa Varma</byline> <bylineText>EDITED DEEPA VARMA</bylineText> <bylineFull>EDITED DEEPA VARMA</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.</metaDescription> <articlePDF/> <teaserImage/> <teaser>More research is needed on “the impact on health outcomes when specialty services are unavailable,” the authors wrote.</teaser> <title>Study Finds Variations in Pediatric Dermatologists Who Accept Medicaid</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>2</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>25</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>38029</term> <term canonical="true">271</term> <term>203</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Study Finds Variations in Pediatric Dermatologists Who Accept Medicaid</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p> <span class="tag metaDescription">Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.</span> <br/><br/> </p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.</li> <li>They collected physician and practice characteristics from the US Census American Community Survey data and a web search.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.</li> <li>Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (<em>P</em> &lt; .001).</li> <li>Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; <em>P</em> = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).</li> <li>Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (<em>P</em> = .001).</li> </ul> <h2>IN PRACTICE:</h2> <p>“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.<br/><br/></p> <h2>SOURCE:</h2> <p>The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published <span class="Hyperlink"><a href="https://onlinelibrary.wiley.com/doi/10.1111/pde.15656">online</a></span> in <em>Pediatric Dermatology</em>.<br/><br/></p> <h2>LIMITATIONS:</h2> <p>Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.<br/><br/></p> <h2>DISCLOSURES:</h2> <p>The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.<br/><br/></p> <p> <em>This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/medicaid-acceptance-among-pediatric-dermatologists-varies-2024a1000c4w">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Dermatofibrosarcoma Protuberans More Common In Black Patients, Analysis Finds

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Changed
Tue, 07/02/2024 - 14:45

 

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

  • Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
  • A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
  • DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

  • The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
  • The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
  • The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
  • Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

  • Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
  • A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
  • DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

  • The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
  • The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
  • The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
  • Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

  • Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
  • A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
  • DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

  • The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
  • The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
  • The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
  • Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study</metaDescription> <articlePDF/> <teaserImage/> <teaser>Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP.</teaser> <title>Dermatofibrosarcoma Protuberans More Common In Black Patients, Analysis Finds</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> <term>31</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">285</term> <term>245</term> <term>66772</term> <term>203</term> <term>263</term> <term>292</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Dermatofibrosarcoma Protuberans More Common In Black Patients, Analysis Finds</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p><span class="tag metaDescription">The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study</span> that also found that larger tumor size and older age were associated with survival outcomes.<br/><br/></p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.</li> <li>A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.</li> <li>DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).</li> <li>The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (<em>P</em> &lt; .001 for all).</li> <li>The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; <em>P</em> &lt; .001) and larger tumor size (≥ 3 cm; HR, 5.34; <em>P</em> = .002) were associated with significantly worse cancer-specific survival.</li> <li>Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.</li> </ul> <h2>IN PRACTICE:</h2> <p>“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”<br/><br/></p> <h2>SOURCE:</h2> <p>The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published <span class="Hyperlink"><a href="https://www.jaad.org/article/S0190-9622(24)00956-3/abstract">online</a></span> on June 20 in the <em>Journal of the American Academy of Dermatology</em>.<br/><br/></p> <h2>LIMITATIONS:</h2> <p>Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.<br/><br/></p> <h2>DISCLOSURES:</h2> <p>The study did not receive any funding support. The authors declared no conflicts of interest.<br/><br/></p> <p> <em>This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/rare-cutaneous-sarcoma-incidence-twice-high-black-2024a1000c2v">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Debate Over Axial Involvement in Psoriatic Arthritis Still Unresolved Despite New Studies

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Changed
Tue, 07/02/2024 - 13:45

— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

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— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>VIENNA — While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumato</metaDescription> <articlePDF/> <teaserImage/> <teaser>Data from two studies corroborated what was already known about axial psoriatic arthritis rather than help define or differentiate it further from axial spondyloarthritis.</teaser> <title>Debate Over Axial Involvement in Psoriatic Arthritis Still Unresolved Despite New Studies</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>2</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">26</term> <term>13</term> </publications> <sections> <term canonical="true">53</term> <term>39313</term> </sections> <topics> <term canonical="true">282</term> <term>299</term> <term>183</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Debate Over Axial Involvement in Psoriatic Arthritis Still Unresolved Despite New Studies</title> <deck/> </itemMeta> <itemContent> <p><span class="dateline">VIENNA</span> — While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual <span class="Hyperlink">European Congress of Rheumatology </span>do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).</p> <p>In both the <span class="Hyperlink"><a href="https://journals.sagepub.com/doi/10.1177/1759720X211057975">AXIS</a></span> study and <span class="Hyperlink"><a href="https://reuma.pt/en/">Reuma.pt</a></span>, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the <span class="Hyperlink"><a href="https://apps-congress.eular.org/eular2024/en-GB/pag/session/1905">Axial Involvement in PsA and SpA</a></span> session at EULAR 2024.<br/><br/></p> <h2>The One-Million-Dollar Question</h2> <p>“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.</p> <p>“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.<br/><br/>The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.<br/><br/>There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.<br/><br/>Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.<br/><br/></p> <h2>Shared Characteristics</h2> <p>But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.</p> <p>While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.<br/><br/>Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.<br/><br/>“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [<span class="Hyperlink"><a href="https://www.asas-group.org/">Assessment of Spondyloarthritis International Society</a></span>] or to GRAPPA [<span class="Hyperlink"><a href="https://www.grappanetwork.org/">Group for Research and Assessment of Psoriasis and Psoriatic Arthritis</a></span>],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”<br/><br/>To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.<br/><br/></p> <h2>AXIS Study ‘Gives Answers’</h2> <p>More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.</p> <p>The AXIS study is a <span class="Hyperlink"><a href="https://www.grappanetwork.org/axis-study/">joint project of ASAS and GRAPPA</a></span> that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.<br/><br/>“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.<br/><br/>The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.<br/><br/>Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.<br/><br/>“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.<br/><br/>Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.<br/><br/>Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”<br/><br/>Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”<br/><br/></p> <h2>Axial PsA in the Portuguese Population</h2> <p>Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some <span class="Hyperlink"><a href="https://ard.bmj.com/content/83/Suppl_1/11.2">real-world data</a></span> on axial PsA from Reuma.pt.</p> <p>Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.<br/><br/>The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.<br/><br/>About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.<br/><br/>Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).<br/><br/>Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.<br/><br/>“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.<br/><br/>“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.<br/><br/>Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/axial-involvement-psoriatic-arthritis-still-defies-2024a1000c7p">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Pyzchiva Receives FDA Approval as Third Ustekinumab Biosimilar

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Tue, 07/02/2024 - 12:39

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

fda_icon2_web.jpg

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

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The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

fda_icon2_web.jpg

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

fda_icon2_web.jpg

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

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All rights reserved. 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This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.<br/><br/>[[{"fid":"174399","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"FDA icon","field_file_image_credit[und][0][value]":"Wikimedia Commons/FitzColinGerald/Creative Commons License","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:</p> <ul class="body"> <li>Moderate to severe <span class="Hyperlink">plaque psoriasis</span> in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy </li> <li>Active <span class="Hyperlink">psoriatic arthritis</span> in adults and pediatric patients aged 6 years or older with moderately to severely active <span class="Hyperlink">Crohn’s disease</span> or <span class="Hyperlink">ulcerative colitis</span></li> </ul> <p>It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. <br/><br/>Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-second-ustekinumab-biosimilar-2024a10007ge">ustekinumab-aekn (Selarsdi)</a></span>.<br/><br/>Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-third-ustekinumab-biosimilar-2024a1000c74">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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