TBD Meeting (5391-19)

LAKE BUENA VISTA, FLA. – Digital health technology is vastly expanding the real-world data pool for clinical and comparative effectiveness research, according to Jeffrey Curtis, MD.

HASLOO/ThinkStock

The trick is to harness the power of that data to improve patient care and outcomes, and that can be achieved in part through linkage of data sources and through point-of-care access, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

“We want to take care of patients, but probably what you and I also want is to have real-world evidence ... evidence relevant for people [we] take care of on a day-to-day basis – not people in highly selected phase 3 or even phase 4 trials,” he said.

Real-world data, which gained particular cachet through the 21st Century Cures Act permitting the Food and Drug Administration to consider real-world evidence as part of the regulatory process and in post-marketing surveillance, includes information from electronic health records (EHRs), health plan claims, traditional registries, and mobile health and technology, explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Courtesy University of Alabama at Birmingham

“And you and I want it because patients are different, and in medicine we only have about 20% of patients where there is direct evidence about what we should do,” he added. “Give me the trial that describes the 75-year-old African American smoker with diabetes and how well he does on biologic du jour; there’s no trial like that, and yet you and I need to make those kinds of decisions in light of patients’ comorbidities and other features.”

Generating real-world evidence, however, requires new approaches and new tools, he said, explaining that efficiency is key for applying the data in busy practices, as is compatibility with delivering an intervention and with randomization.

Imagine using the EHR at the point of care to look up what happened to “the last 10 patients like this” based on how they were treated by you or your colleagues, he said.

“That would be useful information to have. In fact, the day is not so far in the future where you could, perhaps, randomize within your EHR if you had a clinically important question that really needed an answer and a protocol attached,” he added.
 

Real-world data collection

Pragmatic trials offer one approach to garnering real-world data by addressing a simple question – usually with a hard outcome – using very few inclusion and exclusion criteria, Dr. Curtis said, describing the recently completed VERVE Zoster Vaccine trial.

He and his colleagues randomized 617 patients from 33 sites to look at the safety of the live-virus Zostavax herpes zoster vaccine in rheumatoid arthritis patients over age 50 years on any anti–tumor necrosis factor (anti-TNF) therapy. Half of the patients received saline, the other half received the vaccine, and no cases of varicella zoster occurred in either group.

“So, to the extent that half of 617 people with zero cases was reassuring, we now have some evidence where heretofore there was none,” he said, noting that those results will be presented at the 2019 American College of Rheumatology annual meeting. “But the focus of this talk is not on vaccination, it’s really on how we do real-world effectiveness or safety studies in a way that doesn’t slow us way down and doesn’t require some big research operation.”

One way is through efficient recruitment, and depending on how complicated the study is, qualified patients may be easily identifiable through the EHR. In fact, numerous tools are available to codify and search both structured and unstructured data, Dr. Curtis said, noting that he and his colleagues used the web-based i2b2 Query Tool for the VERVE study.

The study sites that did the best with recruiting had the ability to search their own EHRs for patients who met the inclusion criteria, and those patients were then invited to participate. A short video was created to educate those who were interested, and a “knowledge review” quiz was administered afterward to ensure informed consent, which was provided via digital signature.

Health plan and other “big data” can also be very useful for answering certain questions. One example is how soon biologics should be stopped before elective orthopedic surgery? Dr. Curtis and colleagues looked at this using claims data for nearly 4,300 patients undergoing elective hip or knee arthroplasty and found no evidence that administering infliximab within 4 weeks of surgery increased serious infection risk within 30 days or prosthetic joint infection within 1 year.

“Where else are you going to go run a prospective study of 4,300 elective hips and knees,” he said, stressing that it wouldn’t be easy.

Other sources that can help generate real-world effectiveness data include traditional or single-center registries and EHR-based registries.

“The EHR registries are, I think, the newest that many are part of in our field,” he said, noting that “a number of groups are aggregating that,” including the ACR RISE registry and some physician groups, for example.

“What we’re really after is to have a clinically integrated network and a learning health care environment,” he explained, adding that the goal is to develop care pathways.

The approach represents a shift from evidence-based practice to practice-based evidence, he noted.

“When you and I practice, we’re generating that evidence and now we just need to harness that data to get smarter to take care of patients,” he said, adding that the lack of randomization for much of these data isn’t necessarily a problem.

“Do you have to randomize? I would argue that you don’t necessarily have to randomize if the source of variability in how we treat patients is very related to patients’ characteristics,” he said.

If the evidence for a specific approach is weak, or a decision is based on physician preference, physician practice, or insurance company considerations instead of patient characteristics, randomization may not be necessary, he explained.

In fact, insurance company requirements often create “natural experiments” that can be used to help identify better practices. For example, if one only covers adalimumab for first-line TNF inhibition, and another has a “different fail-first policy and that’s not first line and everybody gets some other TNF inhibitor, then I can probably compare those quite reasonably,” he said.

“That’s a great setting where you might not need randomization.”

Of note, “having more data sometimes trumps smarter algorithms,” but that means finding and linking more data that “exist in the wild,” Dr. Curtis said.

Linking data sources

When he and his colleagues wanted to assess the cost of not achieving RA remission, no single data source provided all of the information they needed. They used both CORRONA registry data and health claims data to look at various outcome measures across disease activity categories and with adjustment for comorbidity clusters. They previously reported on the feasibility and validity of the approach.

“We’re currently doing another project where one of the local Blue Cross plans said ‘I’m interested to support you to see how efficient you are; we will donate or loan you our claims data [and] let you link it to your practice so you can actually tell us ... cost conditional on [a patient’s] disease activity,’ ” he said.

Another example involves a recent study looking at biomarker-based cardiovascular disease risk prediction in RA using data from nearly 31,000 Medicare patients linked with multibiomarker disease activity (MBDA) test results, with which they “basically built and validated a risk prediction model,” he said.

The point is that such data linkage provided tools for use at the point of care that can predict CVD risk using “some simple things that you and I have in our EHR,” he said. “But you couldn’t do this if you had to assemble a prospective cohort of tens of thousands of arthritis patients and then wait years for follow-up.”

Patient-reported outcomes collected at the point of care and by patients at home between visits, such as digital data collected via wearable technology, can provide additional information to help improve patient care and management.

“My interest is not to think about [these data sources] in isolation, but really to think about how we bring these together,” he said. “I’m interested in maximizing value for both patients and clinicians, and not having to pick only one of these data sources, but really to harness several of them if that’s what we need to take better care of patients and to answer important questions.”

Doing so is increasingly important given the workforce shortage in rheumatology, he noted.

“The point is that we’re going to need to be a whole lot more efficient as a field because there are going to be fewer of us even at a time when more of us are needed,” he said.

It’s a topic in which the ACR has shown a lot of interest, he said, noting that he cochaired a preconference course on mobile health technologies at the 2018 ACR annual meeting and is involved with a similar course on “big data” ahead of the 2019 meeting.

The thought of making use of the various digital health and “big data” sources can be overwhelming, but the key is to start with the question that needs an answer or the problem that needs to be solved.

“Don’t start with the data,” he explained. “Start with [asking] ... ‘What am I trying to do?’ ”

Dr. Curtis reported funding from the National Institute on Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Digital health technology is vastly expanding the real-world data pool for clinical and comparative effectiveness research, according to Jeffrey Curtis, MD.

HASLOO/ThinkStock

The trick is to harness the power of that data to improve patient care and outcomes, and that can be achieved in part through linkage of data sources and through point-of-care access, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

“We want to take care of patients, but probably what you and I also want is to have real-world evidence ... evidence relevant for people [we] take care of on a day-to-day basis – not people in highly selected phase 3 or even phase 4 trials,” he said.

Real-world data, which gained particular cachet through the 21st Century Cures Act permitting the Food and Drug Administration to consider real-world evidence as part of the regulatory process and in post-marketing surveillance, includes information from electronic health records (EHRs), health plan claims, traditional registries, and mobile health and technology, explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Courtesy University of Alabama at Birmingham

“And you and I want it because patients are different, and in medicine we only have about 20% of patients where there is direct evidence about what we should do,” he added. “Give me the trial that describes the 75-year-old African American smoker with diabetes and how well he does on biologic du jour; there’s no trial like that, and yet you and I need to make those kinds of decisions in light of patients’ comorbidities and other features.”

Generating real-world evidence, however, requires new approaches and new tools, he said, explaining that efficiency is key for applying the data in busy practices, as is compatibility with delivering an intervention and with randomization.

Imagine using the EHR at the point of care to look up what happened to “the last 10 patients like this” based on how they were treated by you or your colleagues, he said.

“That would be useful information to have. In fact, the day is not so far in the future where you could, perhaps, randomize within your EHR if you had a clinically important question that really needed an answer and a protocol attached,” he added.
 

Real-world data collection

Pragmatic trials offer one approach to garnering real-world data by addressing a simple question – usually with a hard outcome – using very few inclusion and exclusion criteria, Dr. Curtis said, describing the recently completed VERVE Zoster Vaccine trial.

He and his colleagues randomized 617 patients from 33 sites to look at the safety of the live-virus Zostavax herpes zoster vaccine in rheumatoid arthritis patients over age 50 years on any anti–tumor necrosis factor (anti-TNF) therapy. Half of the patients received saline, the other half received the vaccine, and no cases of varicella zoster occurred in either group.

“So, to the extent that half of 617 people with zero cases was reassuring, we now have some evidence where heretofore there was none,” he said, noting that those results will be presented at the 2019 American College of Rheumatology annual meeting. “But the focus of this talk is not on vaccination, it’s really on how we do real-world effectiveness or safety studies in a way that doesn’t slow us way down and doesn’t require some big research operation.”

One way is through efficient recruitment, and depending on how complicated the study is, qualified patients may be easily identifiable through the EHR. In fact, numerous tools are available to codify and search both structured and unstructured data, Dr. Curtis said, noting that he and his colleagues used the web-based i2b2 Query Tool for the VERVE study.

The study sites that did the best with recruiting had the ability to search their own EHRs for patients who met the inclusion criteria, and those patients were then invited to participate. A short video was created to educate those who were interested, and a “knowledge review” quiz was administered afterward to ensure informed consent, which was provided via digital signature.

Health plan and other “big data” can also be very useful for answering certain questions. One example is how soon biologics should be stopped before elective orthopedic surgery? Dr. Curtis and colleagues looked at this using claims data for nearly 4,300 patients undergoing elective hip or knee arthroplasty and found no evidence that administering infliximab within 4 weeks of surgery increased serious infection risk within 30 days or prosthetic joint infection within 1 year.

“Where else are you going to go run a prospective study of 4,300 elective hips and knees,” he said, stressing that it wouldn’t be easy.

Other sources that can help generate real-world effectiveness data include traditional or single-center registries and EHR-based registries.

“The EHR registries are, I think, the newest that many are part of in our field,” he said, noting that “a number of groups are aggregating that,” including the ACR RISE registry and some physician groups, for example.

“What we’re really after is to have a clinically integrated network and a learning health care environment,” he explained, adding that the goal is to develop care pathways.

The approach represents a shift from evidence-based practice to practice-based evidence, he noted.

“When you and I practice, we’re generating that evidence and now we just need to harness that data to get smarter to take care of patients,” he said, adding that the lack of randomization for much of these data isn’t necessarily a problem.

“Do you have to randomize? I would argue that you don’t necessarily have to randomize if the source of variability in how we treat patients is very related to patients’ characteristics,” he said.

If the evidence for a specific approach is weak, or a decision is based on physician preference, physician practice, or insurance company considerations instead of patient characteristics, randomization may not be necessary, he explained.

In fact, insurance company requirements often create “natural experiments” that can be used to help identify better practices. For example, if one only covers adalimumab for first-line TNF inhibition, and another has a “different fail-first policy and that’s not first line and everybody gets some other TNF inhibitor, then I can probably compare those quite reasonably,” he said.

“That’s a great setting where you might not need randomization.”

Of note, “having more data sometimes trumps smarter algorithms,” but that means finding and linking more data that “exist in the wild,” Dr. Curtis said.

Linking data sources

When he and his colleagues wanted to assess the cost of not achieving RA remission, no single data source provided all of the information they needed. They used both CORRONA registry data and health claims data to look at various outcome measures across disease activity categories and with adjustment for comorbidity clusters. They previously reported on the feasibility and validity of the approach.

“We’re currently doing another project where one of the local Blue Cross plans said ‘I’m interested to support you to see how efficient you are; we will donate or loan you our claims data [and] let you link it to your practice so you can actually tell us ... cost conditional on [a patient’s] disease activity,’ ” he said.

Another example involves a recent study looking at biomarker-based cardiovascular disease risk prediction in RA using data from nearly 31,000 Medicare patients linked with multibiomarker disease activity (MBDA) test results, with which they “basically built and validated a risk prediction model,” he said.

The point is that such data linkage provided tools for use at the point of care that can predict CVD risk using “some simple things that you and I have in our EHR,” he said. “But you couldn’t do this if you had to assemble a prospective cohort of tens of thousands of arthritis patients and then wait years for follow-up.”

Patient-reported outcomes collected at the point of care and by patients at home between visits, such as digital data collected via wearable technology, can provide additional information to help improve patient care and management.

“My interest is not to think about [these data sources] in isolation, but really to think about how we bring these together,” he said. “I’m interested in maximizing value for both patients and clinicians, and not having to pick only one of these data sources, but really to harness several of them if that’s what we need to take better care of patients and to answer important questions.”

Doing so is increasingly important given the workforce shortage in rheumatology, he noted.

“The point is that we’re going to need to be a whole lot more efficient as a field because there are going to be fewer of us even at a time when more of us are needed,” he said.

It’s a topic in which the ACR has shown a lot of interest, he said, noting that he cochaired a preconference course on mobile health technologies at the 2018 ACR annual meeting and is involved with a similar course on “big data” ahead of the 2019 meeting.

The thought of making use of the various digital health and “big data” sources can be overwhelming, but the key is to start with the question that needs an answer or the problem that needs to be solved.

“Don’t start with the data,” he explained. “Start with [asking] ... ‘What am I trying to do?’ ”

Dr. Curtis reported funding from the National Institute on Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Digital health technology is vastly expanding the real-world data pool for clinical and comparative effectiveness research, according to Jeffrey Curtis, MD.

HASLOO/ThinkStock

The trick is to harness the power of that data to improve patient care and outcomes, and that can be achieved in part through linkage of data sources and through point-of-care access, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

“We want to take care of patients, but probably what you and I also want is to have real-world evidence ... evidence relevant for people [we] take care of on a day-to-day basis – not people in highly selected phase 3 or even phase 4 trials,” he said.

Real-world data, which gained particular cachet through the 21st Century Cures Act permitting the Food and Drug Administration to consider real-world evidence as part of the regulatory process and in post-marketing surveillance, includes information from electronic health records (EHRs), health plan claims, traditional registries, and mobile health and technology, explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Courtesy University of Alabama at Birmingham

“And you and I want it because patients are different, and in medicine we only have about 20% of patients where there is direct evidence about what we should do,” he added. “Give me the trial that describes the 75-year-old African American smoker with diabetes and how well he does on biologic du jour; there’s no trial like that, and yet you and I need to make those kinds of decisions in light of patients’ comorbidities and other features.”

Generating real-world evidence, however, requires new approaches and new tools, he said, explaining that efficiency is key for applying the data in busy practices, as is compatibility with delivering an intervention and with randomization.

Imagine using the EHR at the point of care to look up what happened to “the last 10 patients like this” based on how they were treated by you or your colleagues, he said.

“That would be useful information to have. In fact, the day is not so far in the future where you could, perhaps, randomize within your EHR if you had a clinically important question that really needed an answer and a protocol attached,” he added.
 

Real-world data collection

Pragmatic trials offer one approach to garnering real-world data by addressing a simple question – usually with a hard outcome – using very few inclusion and exclusion criteria, Dr. Curtis said, describing the recently completed VERVE Zoster Vaccine trial.

He and his colleagues randomized 617 patients from 33 sites to look at the safety of the live-virus Zostavax herpes zoster vaccine in rheumatoid arthritis patients over age 50 years on any anti–tumor necrosis factor (anti-TNF) therapy. Half of the patients received saline, the other half received the vaccine, and no cases of varicella zoster occurred in either group.

“So, to the extent that half of 617 people with zero cases was reassuring, we now have some evidence where heretofore there was none,” he said, noting that those results will be presented at the 2019 American College of Rheumatology annual meeting. “But the focus of this talk is not on vaccination, it’s really on how we do real-world effectiveness or safety studies in a way that doesn’t slow us way down and doesn’t require some big research operation.”

One way is through efficient recruitment, and depending on how complicated the study is, qualified patients may be easily identifiable through the EHR. In fact, numerous tools are available to codify and search both structured and unstructured data, Dr. Curtis said, noting that he and his colleagues used the web-based i2b2 Query Tool for the VERVE study.

The study sites that did the best with recruiting had the ability to search their own EHRs for patients who met the inclusion criteria, and those patients were then invited to participate. A short video was created to educate those who were interested, and a “knowledge review” quiz was administered afterward to ensure informed consent, which was provided via digital signature.

Health plan and other “big data” can also be very useful for answering certain questions. One example is how soon biologics should be stopped before elective orthopedic surgery? Dr. Curtis and colleagues looked at this using claims data for nearly 4,300 patients undergoing elective hip or knee arthroplasty and found no evidence that administering infliximab within 4 weeks of surgery increased serious infection risk within 30 days or prosthetic joint infection within 1 year.

“Where else are you going to go run a prospective study of 4,300 elective hips and knees,” he said, stressing that it wouldn’t be easy.

Other sources that can help generate real-world effectiveness data include traditional or single-center registries and EHR-based registries.

“The EHR registries are, I think, the newest that many are part of in our field,” he said, noting that “a number of groups are aggregating that,” including the ACR RISE registry and some physician groups, for example.

“What we’re really after is to have a clinically integrated network and a learning health care environment,” he explained, adding that the goal is to develop care pathways.

The approach represents a shift from evidence-based practice to practice-based evidence, he noted.

“When you and I practice, we’re generating that evidence and now we just need to harness that data to get smarter to take care of patients,” he said, adding that the lack of randomization for much of these data isn’t necessarily a problem.

“Do you have to randomize? I would argue that you don’t necessarily have to randomize if the source of variability in how we treat patients is very related to patients’ characteristics,” he said.

If the evidence for a specific approach is weak, or a decision is based on physician preference, physician practice, or insurance company considerations instead of patient characteristics, randomization may not be necessary, he explained.

In fact, insurance company requirements often create “natural experiments” that can be used to help identify better practices. For example, if one only covers adalimumab for first-line TNF inhibition, and another has a “different fail-first policy and that’s not first line and everybody gets some other TNF inhibitor, then I can probably compare those quite reasonably,” he said.

“That’s a great setting where you might not need randomization.”

Of note, “having more data sometimes trumps smarter algorithms,” but that means finding and linking more data that “exist in the wild,” Dr. Curtis said.

Linking data sources

When he and his colleagues wanted to assess the cost of not achieving RA remission, no single data source provided all of the information they needed. They used both CORRONA registry data and health claims data to look at various outcome measures across disease activity categories and with adjustment for comorbidity clusters. They previously reported on the feasibility and validity of the approach.

“We’re currently doing another project where one of the local Blue Cross plans said ‘I’m interested to support you to see how efficient you are; we will donate or loan you our claims data [and] let you link it to your practice so you can actually tell us ... cost conditional on [a patient’s] disease activity,’ ” he said.

Another example involves a recent study looking at biomarker-based cardiovascular disease risk prediction in RA using data from nearly 31,000 Medicare patients linked with multibiomarker disease activity (MBDA) test results, with which they “basically built and validated a risk prediction model,” he said.

The point is that such data linkage provided tools for use at the point of care that can predict CVD risk using “some simple things that you and I have in our EHR,” he said. “But you couldn’t do this if you had to assemble a prospective cohort of tens of thousands of arthritis patients and then wait years for follow-up.”

Patient-reported outcomes collected at the point of care and by patients at home between visits, such as digital data collected via wearable technology, can provide additional information to help improve patient care and management.

“My interest is not to think about [these data sources] in isolation, but really to think about how we bring these together,” he said. “I’m interested in maximizing value for both patients and clinicians, and not having to pick only one of these data sources, but really to harness several of them if that’s what we need to take better care of patients and to answer important questions.”

Doing so is increasingly important given the workforce shortage in rheumatology, he noted.

“The point is that we’re going to need to be a whole lot more efficient as a field because there are going to be fewer of us even at a time when more of us are needed,” he said.

It’s a topic in which the ACR has shown a lot of interest, he said, noting that he cochaired a preconference course on mobile health technologies at the 2018 ACR annual meeting and is involved with a similar course on “big data” ahead of the 2019 meeting.

The thought of making use of the various digital health and “big data” sources can be overwhelming, but the key is to start with the question that needs an answer or the problem that needs to be solved.

“Don’t start with the data,” he explained. “Start with [asking] ... ‘What am I trying to do?’ ”

Dr. Curtis reported funding from the National Institute on Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Workforce gaps loom large in rheumatology, but efforts on both the federal and state levels address the problem, according to the chair of the American College of Rheumatology’s Government Affairs Committee, Angus B. Worthing, MD.

“We have a workforce gap that’s growing in adult arthritis; demand is increasing, and supply is decreasing,” Dr. Worthing said during an update on the committee’s activities at the annual meeting of the Florida Society of Rheumatology.

A similar “grave discrepancy” plagues pediatric rheumatology, said Dr. Worthing, a partner in a private rheumatology practice in the Washington, D.C., area.

“But these are fundamentally different,” he said, explaining that there is an oversupply of applicants for adult rheumatology fellowship spots, whereas only half of the available spots in pediatric rheumatology are being filled.

“We’re unfortunately having to turn away highly qualified [adult rheumatology] applicants, because we don’t have enough money to fund fellowship positions in the United States; about 100 doctors a year who wanted to be rheumatologists are going into other specialties,” he said. “It’s a different problem in pediatric rheumatology where you spend 2-3 extra years to earn less money than you would as a general pediatrician.”

The American College of Rheumatology is working to “find those dollars,” to alleviate the problems, he said, encouraging those who are concerned about the workforce issues to consider investing in the Rheumatology Research Foundation, which is a “huge supporter of rheumatology fellowships.”

Another proposal involves loan repayment plans for health professionals who agree to work at least 2 years in pediatric medicine.

“There’s an active bill that you can send an e-mail on right now,” Dr. Worthing said.

The bill, titled the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness [EMPOWER] for Health Act,” represents an effort on the federal level to increase access to pediatric medical subspecialists by increasing the number who practice in underserved areas.


“It was introduced the day after we spoke on the Hill in May to leaders about this [issue],” he said.

Another effort is underway in Georgia, where a legislator who has lupus is working with the ACR on legislation that would allow the state to repay up to $25,000 on loans for cognitive specialists who agree to work in the state for a period of time.

The ACR is also working to maintain Deferred Action for Childhood Arrivals (DACA) protections for recipients pursuing medical education, who could potentially help to alleviate the shortages, he noted.

The problem of workforce issues is multifaceted and it requires a multipronged approach, Dr. Worthing said.

“It will not be solved by the American College of Rheumatology alone; I think it will end up being solved by people on the ground working with their primary care physicians and referring doctors to try to close the gap and try to see patients when they’re needed,” he said.

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

The Florida Society of Rheumatology is an excellent state conference that is very well attended because of the comprehensive clinical topics covered by esteemed faculty. Every year, there is a balance of patient care lectures and updates in advocacy, billing, and coding. Clinicians need a combination of both arenas to be successful with the day-to-day practice of rheumatology and to render evidenced-based patient care. This year, the FSR certainly delivered on this mission as reflected by articles on these presentations published at MDedge Rheumatology. An added focus this year was how to leverage technology in a rheumatology practice to capture patient-reported outcomes (PROs) to better understand issues affecting our patient population and improve therapy plans where indicated.

In his lecture on digital PROs, Jeffrey Curtis, MD, explained the difference between active capture of data through tools such as the Routine Assessment of Patient Index Data 3 (RAPID3) or Health Assessment Questionnaire (HAQ) and passive capture through wearable devices such as a Fitbit or Apple watch. A key point for the audience was that this information improves clinical care and improves medical decision making, and thus all rheumatologists should consider using these tools in practice. Dr. Curtis, William J. Koopman Endowed Professor in Rheumatology and Immunology and director of the UAB Arthritis Clinical Intervention Program at the University of Alabama at Birmingham, is well aware of the practical concerns that face clinicians, namely that this is time consuming. He suggests to keep it short and find a tool that works for you in your practice to understand how your patients are progressing on a treatment regimen. He was clear that “data for the sake of data is not compelling for patients [or clinicians].” The ideal is not to paralyze your practice and drown in patient questionnaires but rather to empower patients to report using standardized tools so we can effect change that will help us to treat rheumatic diseases.

An important point mentioned during this lecture was to keep in mind that, if a patient appears to be a “nonresponder” on RAPID3, for example, it is important to understand whether the patient has a confounding comorbidity, such as fibromyalgia, that may account for the limited improvement.

Michelle Petri, MD, gave two excellent talks at FSR this year. Her lectures are packed with excellent pearls about treating patients with systemic lupus erythematosus. Interestingly, she said to never underestimate the prognostic factor of a low C3. This can indicate a worse clinical course is ahead. In addition, she reminds us as clinicians to protect the kidneys of our lupus patients who have renal disease by avoiding common toxins such as NSAIDs and CT contrast. Of course, she reminds us to use the lowest dose of steroids possible during flares, as prednisone is directly or indirectly responsible for 80% of organ damage over 15 years. She reminds us that lupus patients do not die of lupus. They have a 2.66-fold higher risk of cardiovascular events than the general public. In addition to maintaining lupus patients on hydroxychloroquine, Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore, noted that vitamin D can have cardiovascular and hematologic benefits along with reducing thrombosis in some clinical studies. Low vitamin D was significantly associated with deep venous thrombosis.

In his lecture, Leonard Calabrese, DO, made a compelling argument for the rheumatologists in the audience to call the local oncologists with whom they work. We need to discuss and collaborate on the care of patients experiencing immune-mediated adverse events from exposure to checkpoint inhibitors used to treat malignancy. There is a limited mechanistic understanding of these adverse events, but as rheumatologists we need to get involved and help these patients. We are the experts in managing these newly emerging autoimmune events. We can help to create the best possible therapeutic interventions to help our oncology colleagues with these challenging cases, Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic, said.

Besides paying our dues to be members of the FSR, it is important for us as rheumatologists to get involved at the state legislature and national level to bring about change for our practices and patients. Currently, the climate can be hostile for reimbursement and for our patients to get the therapies they need. In another presentation, Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, described recent successes at the national level, and he also discussed how we can have our voices heard at the state and national level to protect our profession and the people who rely on our expertise. The FSR and other state rheumatology organizations, as well as the ACR, need our support to continue to be the collective voice for what is right for clinicians and patients alike.
 

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The Florida Society of Rheumatology is an excellent state conference that is very well attended because of the comprehensive clinical topics covered by esteemed faculty. Every year, there is a balance of patient care lectures and updates in advocacy, billing, and coding. Clinicians need a combination of both arenas to be successful with the day-to-day practice of rheumatology and to render evidenced-based patient care. This year, the FSR certainly delivered on this mission as reflected by articles on these presentations published at MDedge Rheumatology. An added focus this year was how to leverage technology in a rheumatology practice to capture patient-reported outcomes (PROs) to better understand issues affecting our patient population and improve therapy plans where indicated.

In his lecture on digital PROs, Jeffrey Curtis, MD, explained the difference between active capture of data through tools such as the Routine Assessment of Patient Index Data 3 (RAPID3) or Health Assessment Questionnaire (HAQ) and passive capture through wearable devices such as a Fitbit or Apple watch. A key point for the audience was that this information improves clinical care and improves medical decision making, and thus all rheumatologists should consider using these tools in practice. Dr. Curtis, William J. Koopman Endowed Professor in Rheumatology and Immunology and director of the UAB Arthritis Clinical Intervention Program at the University of Alabama at Birmingham, is well aware of the practical concerns that face clinicians, namely that this is time consuming. He suggests to keep it short and find a tool that works for you in your practice to understand how your patients are progressing on a treatment regimen. He was clear that “data for the sake of data is not compelling for patients [or clinicians].” The ideal is not to paralyze your practice and drown in patient questionnaires but rather to empower patients to report using standardized tools so we can effect change that will help us to treat rheumatic diseases.

An important point mentioned during this lecture was to keep in mind that, if a patient appears to be a “nonresponder” on RAPID3, for example, it is important to understand whether the patient has a confounding comorbidity, such as fibromyalgia, that may account for the limited improvement.

Michelle Petri, MD, gave two excellent talks at FSR this year. Her lectures are packed with excellent pearls about treating patients with systemic lupus erythematosus. Interestingly, she said to never underestimate the prognostic factor of a low C3. This can indicate a worse clinical course is ahead. In addition, she reminds us as clinicians to protect the kidneys of our lupus patients who have renal disease by avoiding common toxins such as NSAIDs and CT contrast. Of course, she reminds us to use the lowest dose of steroids possible during flares, as prednisone is directly or indirectly responsible for 80% of organ damage over 15 years. She reminds us that lupus patients do not die of lupus. They have a 2.66-fold higher risk of cardiovascular events than the general public. In addition to maintaining lupus patients on hydroxychloroquine, Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore, noted that vitamin D can have cardiovascular and hematologic benefits along with reducing thrombosis in some clinical studies. Low vitamin D was significantly associated with deep venous thrombosis.

In his lecture, Leonard Calabrese, DO, made a compelling argument for the rheumatologists in the audience to call the local oncologists with whom they work. We need to discuss and collaborate on the care of patients experiencing immune-mediated adverse events from exposure to checkpoint inhibitors used to treat malignancy. There is a limited mechanistic understanding of these adverse events, but as rheumatologists we need to get involved and help these patients. We are the experts in managing these newly emerging autoimmune events. We can help to create the best possible therapeutic interventions to help our oncology colleagues with these challenging cases, Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic, said.

Besides paying our dues to be members of the FSR, it is important for us as rheumatologists to get involved at the state legislature and national level to bring about change for our practices and patients. Currently, the climate can be hostile for reimbursement and for our patients to get the therapies they need. In another presentation, Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, described recent successes at the national level, and he also discussed how we can have our voices heard at the state and national level to protect our profession and the people who rely on our expertise. The FSR and other state rheumatology organizations, as well as the ACR, need our support to continue to be the collective voice for what is right for clinicians and patients alike.
 

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The Florida Society of Rheumatology is an excellent state conference that is very well attended because of the comprehensive clinical topics covered by esteemed faculty. Every year, there is a balance of patient care lectures and updates in advocacy, billing, and coding. Clinicians need a combination of both arenas to be successful with the day-to-day practice of rheumatology and to render evidenced-based patient care. This year, the FSR certainly delivered on this mission as reflected by articles on these presentations published at MDedge Rheumatology. An added focus this year was how to leverage technology in a rheumatology practice to capture patient-reported outcomes (PROs) to better understand issues affecting our patient population and improve therapy plans where indicated.

In his lecture on digital PROs, Jeffrey Curtis, MD, explained the difference between active capture of data through tools such as the Routine Assessment of Patient Index Data 3 (RAPID3) or Health Assessment Questionnaire (HAQ) and passive capture through wearable devices such as a Fitbit or Apple watch. A key point for the audience was that this information improves clinical care and improves medical decision making, and thus all rheumatologists should consider using these tools in practice. Dr. Curtis, William J. Koopman Endowed Professor in Rheumatology and Immunology and director of the UAB Arthritis Clinical Intervention Program at the University of Alabama at Birmingham, is well aware of the practical concerns that face clinicians, namely that this is time consuming. He suggests to keep it short and find a tool that works for you in your practice to understand how your patients are progressing on a treatment regimen. He was clear that “data for the sake of data is not compelling for patients [or clinicians].” The ideal is not to paralyze your practice and drown in patient questionnaires but rather to empower patients to report using standardized tools so we can effect change that will help us to treat rheumatic diseases.

An important point mentioned during this lecture was to keep in mind that, if a patient appears to be a “nonresponder” on RAPID3, for example, it is important to understand whether the patient has a confounding comorbidity, such as fibromyalgia, that may account for the limited improvement.

Michelle Petri, MD, gave two excellent talks at FSR this year. Her lectures are packed with excellent pearls about treating patients with systemic lupus erythematosus. Interestingly, she said to never underestimate the prognostic factor of a low C3. This can indicate a worse clinical course is ahead. In addition, she reminds us as clinicians to protect the kidneys of our lupus patients who have renal disease by avoiding common toxins such as NSAIDs and CT contrast. Of course, she reminds us to use the lowest dose of steroids possible during flares, as prednisone is directly or indirectly responsible for 80% of organ damage over 15 years. She reminds us that lupus patients do not die of lupus. They have a 2.66-fold higher risk of cardiovascular events than the general public. In addition to maintaining lupus patients on hydroxychloroquine, Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore, noted that vitamin D can have cardiovascular and hematologic benefits along with reducing thrombosis in some clinical studies. Low vitamin D was significantly associated with deep venous thrombosis.

In his lecture, Leonard Calabrese, DO, made a compelling argument for the rheumatologists in the audience to call the local oncologists with whom they work. We need to discuss and collaborate on the care of patients experiencing immune-mediated adverse events from exposure to checkpoint inhibitors used to treat malignancy. There is a limited mechanistic understanding of these adverse events, but as rheumatologists we need to get involved and help these patients. We are the experts in managing these newly emerging autoimmune events. We can help to create the best possible therapeutic interventions to help our oncology colleagues with these challenging cases, Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic, said.

Besides paying our dues to be members of the FSR, it is important for us as rheumatologists to get involved at the state legislature and national level to bring about change for our practices and patients. Currently, the climate can be hostile for reimbursement and for our patients to get the therapies they need. In another presentation, Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, described recent successes at the national level, and he also discussed how we can have our voices heard at the state and national level to protect our profession and the people who rely on our expertise. The FSR and other state rheumatology organizations, as well as the ACR, need our support to continue to be the collective voice for what is right for clinicians and patients alike.
 

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Patient-reported outcomes (PROs) have the potential to transform patient care in rheumatology, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

“You probably already use a lot of PROs in your data; even if you measure nothing via a questionnaire, you are still collecting it in a qualitative way – you just might not call it that,” he told attendees at the annual meeting of the Florida Society of Rheumatology.

The key to making the most of PROs is efficient collection of relevant, interpretable, actionable data for improving patient care and outcomes, said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.
 

PROs: The “what” and “why”

A wide variety of tools are available to capture PROs during daily practice, Dr. Curtis said. Active data capture tools include rheumatology- or domain-specific measures such as the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDAI and BASFI), the Routine Assessment of Patient Index Data 3 (RAPID3), the original and Multidimensional Health Assessment Questionnaires (HAQ and MDHAQ), as well as disease-agnostic measures like the 36-item Short Form Survey (SF-36), EuroQol-5D (EQ-5D), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, he explained, adding that passive data also can be derived from various sources, including social media platforms, activity trackers, and reports regarding balance and falls, sleep quality and duration, heart rate and rhythm, and galvanic skin resistance.

Many of these measures represent things patients can track at home between office visits, he said.

However, such measures represent “what we could have” in terms of patient data, whereas “what we do have” falls far short of that, he noted, citing a study in which he and his colleagues found that the use of quantitative measurement for U.S. rheumatoid arthritis (RA) patients is increasing over time, but remains low with only 58% of 439 rheumatologists who responded to an email survey reporting use of such measures (J Rheumatol. 2018;45[1]:40-4).

Those using the measures were more likely to be in group practice and to prescribe tumor necrosis factor inhibitors, and the tools they reported using most often were the HAQ (35.5%) and RAPID3 (27.1%).

Reasons given for not using quantitative measurement included time constraints and electronic availability.

Of note, simulated case scenarios included in the study demonstrated that providing more quantitative information increased the likelihood that a patient would change to a different disease-modifying antirheumatic drug or biologic.

Almost anything clinically relevant can be quantified, but it’s really hard to improve and address problems you’re not measuring, Dr. Curtis said.

“I would contend that PROs are an important part of holistic rheumatology care, and they absolutely impact real and perceived treatment responses,” he added.

In fact, in a study presented at the 2018 European League Against Rheumatism Congress, he and his colleagues found that PROMIS scores with respect to pain interference, sleep disturbance, and fatigue tracked closely with RA patients’ view of their health status and with Clinical Disease Activity Index (CDAI) scores.
 

PROs: The “how”

“Is it merely enough to collect patient data? Is that going to solve the problem? Well, probably not – it really needs to be actionable,” he said. “Outcomes don’t get better by themselves; you really need to be collecting data that you, personally, will find valuable for your patients, and ideally it needs to mean something to patients.”

Many of these suggestions are potentially actionable, he noted.

“You can download these forms on paper; this is already connected or connectable to some people’s electronic health record,” he said. “At a minimum, talk to your EHR vendor about whether this might be available, and if not, why not.”

Choose in-office tools that are quick and simple to use, he advised, noting that he finds 6-8 minutes ideal for patient completion of questionnaires and other measures.

“It’s quite reasonable to write a PRO order,” he said. “The notion would be that you decide what specific PROs you want Mrs. Smith to give you, how often you’d like for her to tell you about those things (what you want from her might be different from the next patient), and she can give you that data from a smartphone or maybe something that she wears, and only the data that you asked for comes back.”

Successful collection of such data requires patient engagement in the process, he said, noting that the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB was recently awarded a grant to help develop an arthritis research registry called Arthritis Power, through which patients can provide data via smartphones, track their own health outcomes, participate in studies and surveys, access educational tools, and receive reminders and feedback.

“One of the things that’s quite important to help engage patients is to encourage them. This isn’t one-way data transfer,” he said.

Keeping them engaged requires “contributive science messaging.” That is, telling them they are “part of something bigger [and that they are] helping answer research questions that patients care about.”

It also helps to “bring back value to them” by explaining that you can help them make their data useful for improving their health and that you can derive insights for or with them based on their data.

“You can ‘game-ify’ it and make it fun,” he said, adding that leveraging the social connections associated with some tools can also help.

However, the promise of better access to needed resources, physicians, and the health care system is perhaps the most compelling point for patient engagement, he said.

“[You can say] to your patient, ‘Mrs. Smith, I’d really like to have your Fitbit or Apple Watch data, and I’d like you to tell me how you’re doing, on your smartphone, once or twice a month – it will take about 10 minutes – because I, as your doctor, think I can take better care of you,’ ” he said. “If that’s the ask, I think that might be the most compelling reason for patients to say yes.”

Of note, a number of patient measures are now compensable, Dr. Curtis said, mentioning depression screening using a PROMIS instrument as one example.

Additionally, two American College of Rheumatology work groups are revising the ACR recommendations on functional status measures and will soon generate an “ACR-approved list” of measures, he said.

He stressed, however, that it in addition to understanding the value of specific tools, it is important to know their limitations.

In the PREDICT study, he and his colleagues demonstrated that patient-reported RAPID3 data, when compared with investigator-based CDAI data for assessing RA patients’ response to certolizumab at 12 weeks and predicting response at 52 weeks, resulted in 11.9% fewer patients being classified as responders (64.7% vs. 76.4%), but the actual response rates at week 52 were similar, with 31.5% and 32.3% of patients in the groups, respectively, achieving a low level of disease activity (Arthritis Rheumatol. 2015;67[12]:3104-12).

The concern regarding the finding is that an insurance company may refuse to continue paying for a drug because of the perceived lack of response and thereby unnecessarily force a switch to an alternate drug based on faulty data, he explained.

“That would be the real-world analog of what this trial evaluated,” he said, adding that this has important implications for treat-to-target, pay-for-performance, and merit-based incentive payment systems. “My point is that we need to know the limitations of our tools ... and it’s to not let insurance [companies] write rules for us ... based upon certain tools that have limitations.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at Advocacy@rheumatology.org to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at Advocacy@rheumatology.org to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Rheumatologists comprise a “tiny sliver” of the U.S. physician pie chart, but their voices are nevertheless being heard and making a difference regarding policies that affect the specialty, according to Angus B. Worthing, MD.

However, given the myriad policy issues on the table, more and louder voices are needed, he said at the annual meeting of the Florida Society of Rheumatology, where, as chair of the American College of Rheumatology’s Government Affairs Committee, he provided an “advocacy update” on the committee’s activities.

Recent ACR “wins” as outlined by Dr. Worthing include:

• The postponement and modification of proposed cuts to Evaluation & Management (E/M) current procedural terminology (CPT) codes.

“Last summer, Medicare proposed that instead of having low-complexity to high-complexity E/M codes, they would condense all of the doctor visits into one code, which would obviously enhance the reimbursement for low complexity, but ding and penalize the reimbursement for high-complexity visits like ours,” said Dr. Worthing, who also is a partner in a private rheumatology practice in the Washington area.

An ACR press release on the proposal led to pivotal coverage of the issue in the New York Times. “It looks like not only did they postpone those cuts, they modified [the proposal], and we’ll find out any day now in the proposal for the next year’s physician fee schedule whether they’ll scrap it entirely and instead try to plus-up E/M code reimbursement for complex patients.”

• The elimination of proposed Merit-based Incentive Payment System (MIPS) adjustments on Medicare drug reimbursement.

A cut to fee-for-service reimbursement for drug costs as a MIPS penalty could have quickly bankrupted rheumatology practices, Dr. Worthing said.

“[The success] was largely out of rheumatologists and others saying that this could quickly stop access to these treatments, because we wouldn’t be able to provide them,” he noted.

• The dampening of proposed musculoskeletal ultrasound reimbursement cuts in Medicare.

Ultrasound is a safe, effective, dynamic, and relatively low-cost diagnostic tool, but Medicare has been considering “absurd” cuts to reimbursement, Dr. Worthing said.

“We’ve been able to have good conversations with Medicare ... to bring that argument to Medicare, and we’ll find out – again, when the physician fee schedule comes out – whether they’ll continue the plan to cut diagnostic ultrasound reimbursement or whether they’ll stop cutting it.”

• The inclusion of more favorable Medicare Advantage regulations for step therapy “grandfathering.”

Medicare Advantage plans were given the chance last summer to use step therapy in Part B medicines for the first time.

“The ACR quickly told the executive branch and officials at [the Department of Health & Human Services (HHS)], that this would not be good for our patients getting medications,” Dr. Worthing said.

Going forward with that plan, and looking back just 108 days to allow people to stay on their medications – as was proposed – wouldn’t work, as some drugs are dosed every 4-6 months, or every year or every 2 years, he said.

“The look of astonishment on the [HHS] deputy secretary’s face when I told him that there was a drug in the U.S. that you give every 2 years was helpful for me to know that these people really need to hear from us before they issue these kinds of regulations,” he said.

The administration listened to the rheumatologists and is going to look back 365 days to keep people on their drugs, he said.

The ACR took the lead on these recent successes, but was also involved in a number of other wins achieved through multisociety efforts, he said.

Examples include securing a $2 billion increase in National Institutes of Health funding, eliminating “gag clauses” that prevent pharmacists from informing patients when it’s cheaper to just buy a drug rather than using their insurance; getting rid of annual caps on physical and other rehabilitation therapy for patients meeting their targets; repealing (before it could take effect) of the Independent Payment Advisory Board established by the Affordable Care Act; and – at least for now – continuing Deferred Action for Childhood Arrivals (DACA) protections that could allow recipients to stay in the country, study, and become doctors, and potentially provide care for up to 100,000 Americans, according to an estimate by the American Medical Association.

Dr. Worthing also noted that the ACR has an Insurance Subcommittee that has been instrumental in many of these and other policy wins, and he encouraged rheumatologists to contact the committee at Advocacy@rheumatology.org to report any sort of “canary-in-the-coal-mine” issues, such as refusal of coverage for a new step therapy, service, or item in your clinic that seems “absurd; doesn’t have merit.”

Send a copy of the policy behind the denial (with private health information redacted), or complete a Health Plan Complaint Form, which can be accessed at the website, he advised.

Rheumatologists can make their voices heard in other ways, he said. The ACR has a number of ongoing advocacy efforts addressing things like drug-pricing models, biosimilar agent interchangeability pathways, step therapy reform, workforce issues, and the need for higher dual X-ray absorptiometry (DXA) reimbursement.

The ACR’s Legislative Action Center offers prewritten letters on a number of timely topics, as well as information about legislators and legislation. An app is available that provides alerts about important legislation.

A timely example is DXA-related, bipartisan, bicameral legislation currently on the table that would more than double reimbursement and “improve access to this critical screening tool,” he said.

“Right now is an excellent time to tell your legislators – and there’s a prewritten letter at the [site] – that this is an important topic,” he said. “Right now, as we get into bills that might come out, spending bills or health-related bills coming up to 2020, it would be wonderful to get a lot of support behind this so that it might be added into some kind of package.”

A similar prewritten letter regarding an active bill that addresses paying off student loans for pediatricians going into subspecialties like pediatric rheumatology also is on the table and could help address workforce shortages, he noted.

“The First Amendment protects your right to petition the government for redress of grievances. I don’t have to tell you this is an era of huge tumult ... protecting [democracy and institutions], protecting your organizations, raising your voice is really important right now,” he said, referencing his new Twitter hashtag that encourages doing one #ThingADay. “You could think of advocacy as an extension of the Hippocratic oath to do no harm on a government and social level.”

Quoting Margaret Mead, Dr. Worthing reminded rheumatologists that their voices matter despite (and in fact, because of) their small numbers: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Dr. Worthing reported having no disclosures.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – When it comes to lupus nephritis, the guidelines – and prevailing wisdom – don’t always get it quite right, according to Michelle A. Petri, MD.

Mitchel L. Zoler/MDedge News

During an update at the annual meeting of the Florida Society of Rheumatology, she outlined five key components of lupus nephritis treatment, and the status of the evidence for each.

Antihypertensive therapy

Antihypertensive therapy isn’t just for hypertension in patients with lupus nephritis – it’s for reducing proteinuria and preventing renal fibrosis, said Dr. Petri, professor of medicine and director of the Hopkins Lupus Center at Johns Hopkins University, Baltimore.

“I get a lot of push-back on this,” she added, explaining that other physicians often will stop the treatment as she prescribed it, because they believe it’s unnecessary.

She described a case involving a 33-year-old African American man with blood pressure of 132/86 mm Hg and grade 3+ ankle edema. Laboratory tests were remarkable for hematocrit (33.4%), white blood cell count (3.1), erythrocyte sedimentation rate (67 mm/hr) and urinalysis (2+ protein by dipstick, 3 red cells/high-power field, no casts). Additionally, 24-hour urine protein showed 400 mg of microalbumin, and he had a positive antinuclear antibody test, positive anti–double stranded DNA, and low complement.

“I’m going to argue really strenuously that he has to be on an ACE inhibitor or an ARB [angiotensin receptor blocker],” she said, explaining that even before an immunosuppressant therapy is started, optimizing ACE inhibitor or ARB therapy can reduce proteinuria by 50%.

The “sweet spot” for blood pressure in these patients is between 110 and 129, she said.

“You don’t want it too low, because you might hurt renal perfusion, but you sure don’t want it above 130,” she said.

The problem is that many physicians think 110 or 112 is too low.

“Not for a lupus nephritis patient,” she said. “It’s really where we want to be.”

ACE inhibitors and ARBs are preferable for reaching this goal, she said, noting that calcium channel blockers have been linked with shorter time to renal failure.

Hydroxychloroquine

Everyone with lupus nephritis should be on hydroxychloroquine, Dr. Petri argued.

“It improves renal outcomes,” she said. “It more than triples the chance that a patient will have a complete renal response.”

Guidelines from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) are in agreement on this, she said.

Even the renal guidelines for lupus nephritis now include hydroxychloroquine as mandatory, she added, noting that it is not necessary to check glucose-6-phosphate dehydrogenase (G6PD) before starting treatment.

In fact, a recent study showed that only 2 of 11 patients with G6PD deficiency had episodes of hemolysis, and those episodes did not occur during hydroxychloroquine therapy. The authors concluded that the routine measurement of G6PD levels and withholding therapy among African American patients with G6PD deficiency is not supported, she said (Arthritis Care Res. 2018;70[3]:481-5).

“Of course, if your patient has renal insufficiency you’re going to have to reduce the dose in half,” she noted.
 

Vitamin D

Modestly increasing 25-hydroxyvitamin D can “greatly, significantly reduce the urine protein – with no cost, with no toxicity,” Dr. Petri said.

In a 2013 study, she and her colleagues showed that a 20‐ng/mL increase in the 25(OH)vitamin D level was associated with a 21% decrease in the odds of having a high disease-activity score, and with a 15% decrease in the odds of having clinically important proteinuria (Arthritis Rheumatol. 2013;65[7]:1865-71).

“But you’ll be fascinated to hear that vitamin D may be an antifibrotic drug, as well,” she noted. “This has been proven in animal models of pulmonary fibrosis ... and although we don’t have proof in lupus nephritis, the animal models are so strong that I think absolutely everybody with lupus nephritis needs to be on vitamin D, both to reduce proteinuria and then, hopefully, as a very cheap antifibrotic drug.”
 

Mycophenolate mofetil

The case Dr. Petri presented involved a patient with International Society of Nephrology class IV disease.

Left untreated, he would be in end-stage renal disease within a year, she said.

“But even with my maximal treatment he has a 23% chance of being in end-stage renal disease in 20 years,” she noted.

This patient had a high National Institutes of Health activity index, but low chronicity, and there were no crescents.

“The reason I mention this is because crescents mean rapidly progressive [glomerular nephritis],” she said. “That’s very urgent; it’s one of the situations where even I will dump on the steroids, because you’ve got to do something fast.”

In this case, however, the best induction therapy is mycophenolate mofetil, she said.

“Boy, our guidelines are wishy-washy on this, and they shouldn’t be,” she said, explaining that “because he’s African American, there are very clear data that mycophenolate is better than cyclophosphamide – our guidelines need to make that very clear.”

In fact, mycophenolate should be the first choice of induction therapy in all cases, except those involving rapidly progressive glomerulonephritis (RPGN), for which cyclophosphamide should be given for at least 3 months before trying to transition to mycophenolate, she stressed.

After about 1 year of treatment, 50% of patients will be complete renal responders, she noted, adding that “in Caucasians, mycophenolate is as good as cyclophosphamide, and in African Americans, mycophenolate is much better.”

“So mycophenolate has won, and for good reason. But is it sufficient to have 50% of patients be complete renal responders at 1 year?” she asked, noting the risk for renal fibrosis in those who respond late in that year or not at all.

“So we really need something that’s much more successful.”
 

Steroids

How much prednisone should lupus nephritis patients get?

As little as possible, according to Dr. Petri.

“I want you to think back to all those times you were taught during you fellowship about dumping on as much prednisone as possible,” she said. “[They] probably aren’t correct.”

She also pulled no punches when it comes to the ACR and EULAR guidelines on prednisone use.

“Both ... are wrong,” she said, explaining that the ACR guidelines are “top-heavy” on prednisone in calling for 0.5-1 mg/kg/day.

“One mg/kg? Like everybody’s the same? I do not object to 1 mg/kg if it’s RPGN, but not for everybody else,” she said.

EULAR guidelines are “less generous,” calling for 0.5 mg/kg/day for 4 weeks, and they make it clear that “you better taper that stuff off.”

“I like that part,” she said. “But still, you’re starting out with a lot of steroid.”

Why the objection? Data show that prednisone is directly or indirectly responsible for 80% of organ damage over 15 years, she said (J Rheumatol. 2003;30[9]:1955-9).

“It’s bad enough to have lupus nephritis; why should you have to be poisoned with prednisone, as well?” she asked. “Now, if the people on prednisone did better, of course I’d have to back off, wouldn’t I?”

Recent data, however, suggest that lupus nephritis patients who are treated with prednisone end up doing worse, and studies being performed outside the United States are beginning to use lower doses of prednisone, she said.

“The rest of the world is lowering the prednisone; our guidelines need to catch up,” she said, adding that she sees no reason why this shouldn’t apply in lupus nephritis.

“Their prednisone should be less than 6 mg, and doses above that level increase organ damage by 50%,” she said, citing a 2009 study in which she and her colleagues found that the hazard ratio for organ damage with prednisone vs. no prednisone was 1.50 for cumulative average doses of 180-360 mg/month, compared with 1.16 for doses up to 180 mg/month (J Rheumatol. 2009;36[3]:560-4).

Even a 20-mg dose has been linked with a fivefold increase the risk of a vascular incident, she added, citing another such study (Am J Epidemiol. 2012;176:708-19).

Dr. Petri is a consultant for GlaxoSmithKline, Merck EMD Serono, Lilly, Janssen, Amgen, Novartis, Exagen, Inova Diagnostics, AstraZeneca, Blackrock Pharma, Glenmark, and UCB.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – “Crude and uninformed.”

That’s how Leonard H. Calabrese, DO, described the general approach to managing immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitor therapy.

Rheumatologists have the expertise to change that, he said during a presentation at the annual meeting of the Florida Society of Rheumatology.

“The therapy is where it’s at – this is where rheumatologists come into play,” said Dr. Calabrese, professor of medicine and chair of clinical immunology at the Cleveland Clinic.

According to relevant guidelines, such as those recently developed by the American Society of Clinical Oncology/National Comprehensive Cancer Network and the Society for the Immunotherapy of Cancer, irAEs are graded on a severity-based scale. Grade 1 events are mild and generally require observation; grade 2 events may include arthralgias and myalgias that are typically treated with symptomatic therapy; grade 3 events involve more serious conditions and may require hospitalization; and grade 4 events are life-threatening and may require targeted therapies.

“Grade 3 – these would be people with profound polyarthritis, vasculitis, myositis – rely heavily on glucocorticoids, and if patients don’t tolerate glucocorticoids or don’t respond to tapering doses, consider the use of [disease-modifying antirheumatic drugs],” he said, noting that the guidelines are vaguely written and refer to both conventional and biologic DMARDs.

“This is all anecdotal at the present time; this is a story to be discovered as we move along,” he explained.

A recommendation for the use of targeted therapies, such as tumor necrosis factor inhibitors, anti-interleukin (IL)-6, and antimetabolites, in patients with the most advanced disease is similarly vague and just represents “the beginning of the beginning,” he said.

The “crude and uninformed” nature of the current approach to irAEs, as he described it, is related to a failure to consider the immunopathogenesis of specific conditions.

“The oncologists, who have done such an incredible job with this – learning about derm[atitis] and colitis that respond to steroids and infliximab, immediately extrapolated that steroids and infliximab are for everything,” he said. “They give it for pneumonitis, they give it for [central nervous system] disease, they give it for everything.”

However, there’s no pathophysiologic basis for doing so, and not surprisingly, some patients don’t respond.

“Here we are sitting on this amazing armamentarium of targeted therapies and only now just starting to ask the questions: ‘Do they offer benefit for these irAEs? Do they offer risk? Will they blunt the antitumoral response of this?’ ” he said.

A “Personal View” published in Lancet Oncology in January 2019 was among the first from the oncology arena to pose these questions (20[1]:PE54-64. doi: 10.1016/S1470-2045[18]30828-3).

“It said, ‘well maybe we should look at the immunopathogenesis of each of these diseases and then pick the therapy – if it’s IL-17 mediated, we’ve got drugs for that; if it’s IL-1 mediated, we’ve got drugs for that; if it’s interferon-mediated, we can deal with that,’ ” he said. “The problem is we don’t yet have detailed immunopathogenic knowledge of these diseases, but it’s coming.”

Data needed to define best treatments

Data also are emerging to define the roles of various targeted therapies for treating irAEs, but most of the evidence remains anecdotal, he said.

For example, anecdotal reports suggest that rituximab has some efficacy in cytopenias, arthritis, and myositis, and a case report suggests that secukinumab and other IL-17 inhibitors may have benefit in psoriasis and inflammatory bowel disease with tumoral progression, he said.

A reasonable question has been whether attacking T cells might be worthwhile given that “these things are all T-cell mediated,” but until very recently, “no one has had the temerity to actually do this,” he said.

However, two cases reported in the June 13 issue of the New England Journal of Medicine described “very successful” treatment of checkpoint inhibitor-associated myocarditis. One case described the use of alemtuzumab in a 71-year-old woman being treated with first-line pembrolizumab for stage IV melanoma, and another case involved the use of abatacept for severe, glucocorticoid-refractory myocarditis in a 66-year-old woman who had been treated with nivolumab for metastatic lung cancer (2019;380:2375-6 and 2377-79).Dr. Calabrese urged rheumatologists who are interested in addressing the treatment of irAEs to “get involved.”

“People need good rheumatologists, and I will tell you that whoever your oncologists are who you refer patients to for cancer – they’re seeing this and they need help,” he said. “Particularly outside of these big major centers, just having someone to lean on is very important.”

Keep in mind, however, that triage is very important, he said, stressing that patients with irAEs “actually need to be seen.”

Between three and five new irAE patients are being seen each week at the Cleveland Clinic, he noted.
 

Need for multidisciplinary collaboration

Collaboration was the focus of an article in the June 2019 issue of the Journal of the National Comprehensive Cancer Network, which looked at the value of a virtual “multidisciplinary toxicity team” for managing cancer irAEs. The investigators found that such an approach was feasible, used by oncology providers, and effective for facilitating toxicity identification and management.

A number of other recent studies have attempted to assess confidence and knowledge of rheumatologists and others with respect to the treatment of irAEs in cancer patients, and the findings highlight the need for education at the oncologist, specialist, generalist, and advanced practitioner level, Dr. Calabrese said, adding that the findings also highlight a need for assistance from “big pharma, which makes these drugs,” in supporting this type of education.

The need for “novel venues for such educational interchange” also was the topic of a study on a new Cleveland Clinic irAE tumor board that he and his colleagues presented at the 2018 annual meeting of the American College of Rheumatology.

The study showed that the tumor board, which is now “one of the most popular conferences at the clinic,” has educational value for participants, and “may increase skill and confidence in patient management.”

“We just present case after case of new things. Last week was autoimmune lipodystrophy from checkpoint inhibitors,” he said, noting that the rheumatologists and oncologists at the clinic co-chair the events.

In another 2018 article, he and coauthor Xavier Mariette, MD, further highlighted the “evolving role of the rheumatologist” in managing cancer treatment–related irAEs.

“We think that rheumatologists have a lot to offer here,” he said. “We understand these drugs better than all of these guys, and as we gain more knowledge in this field, we have guidance, and counsel, and experience to add to this.”

He encouraged rheumatologists to “stay tuned on this, follow this along,” adding that their help is needed.

“It’s really simple – talk to your oncologists and say, ‘Hey, what are you doing with these patients?’ – and I think you’ll have something new, exciting, and invigorating.”

Dr. Calabrese reported serving as a consultant and/or speaker for Bristol-Myers Squibb, Genentech, AbbVie, Pfizer, Crescendo Bioscience, UCB, Janssen, Gilead, Sanofi-Regeneron, Novartis, AstraZeneca, and Amgen.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

sworcester@mdedge.com

LAKE BUENA VISTA, FLA. – Wellness is an antidote to burnout.

That was the message from psychotherapist and author Saundra Jain, PsyD, during a talk focused on “reigniting the flame” in both professional and personal life.

©stanciuc/thinkstockphotos.com

“Wellness is not an afterthought. It simply cannot be,” she said at the annual meeting of the Florida Society of Rheumatology. The “data demand that wellness be elevated.”

That’s true both for patient care and for self care, she stressed, noting that by “wellness” she is referring to the 1948 World Health Organization definition: “... a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

Wellness-enhancing practices – she discussed five that have “the most robust dataset”: exercise, nutrition, mindfulness, social connectedness, and sleep – can improve well-being and reduce burnout through a number of mechanisms, not the least of which are reduced inflammation and reduced depression and anxiety, said Dr. Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

For example, regular exercise is known to reduce chronic inflammation, and the effect has been shown to be independent of weight loss, she noted (Sports Med. 2013;43[4]:243-56).

Mindfulness also has been shown to reduce cortisol production in response to a psychological stressor, and thus may positively affect inflammatory responses, she said (Brain Behav Immun. 2013;27:174-184).

People struggle with the concept of mindfulness, because for many it is a bit foreign to their experience, she said, adding that “what we don’t know, we’re sometimes a little bit afraid of.

“But the data around mindfulness, honestly, is robust – it really, really is,” she said, adding that “you can take people who have not meditated at all, and in 8 weeks impact their inflammation.

“So you don’t have to be a long-term meditator – you do not have to meditate for 18 hours a day sitting in a lotus position in a serene, beautiful location.”

There is no right or wrong way to meditate; it’s all about the practice, she added.

In an effort to help her own patients find wellness, Dr. Jain cofounded the WILD 5 Wellness program and coauthored a related workbook and program called KickStart30 designed to help kick-start the wellness journey.

WILD stands for Wellness Interventions for Life’s Demands, and the program combines the five key evidence-based wellness elements into an easy-to-follow program, she said.

The KickStart30 workbook is available for purchase, with all profits benefiting mental health charities. The approach is as applicable for physician wellness as for patient wellness, she said. The program is simple, prescriptive, trackable, and self-contained, she added.

Wellness-enhancing practices as recommended in the program include:

• 30 minutes of exercise daily for 30 days, with an aim of at least moderate intensity.
• 10 minutes of mindfulness practice each day for 30 days. (Free guided meditations, which she and her colleagues use in their studies of the program, are available at www.WILD5Meditations.com, but a number of other guided meditation apps are available online, she said.) “Of the apps that are available, Headspace, without a doubt, is my favorite,” she said. It requires a paid subscription, but “is so worth it.”
• Implementation of at least four of six sleep hygiene practices each day for 30 days.
• Meeting or calling a minimum of two friends or family members each day for 30 days.
• Logging meals/snacks/beverages/alcohol consumption each day for 30 days, following the Mediterranean-DASH intervention for Neurodegenerative Delay (MIND) diet principles as closely as possible.

Program success requires effort, not perfection, in following the recommendations, and measurement and tracking are essential, Dr. Jain said, noting that a simple tracking tool – the KickStart30–HERO Wellness Scale – was validated in a recent study that has been accepted for publication in Annals of Psychology in the coming months).

A prior study of 82 participants, which she presented in 2016 in a poster at the 29th Annual U.S. Psychiatric and Mental Health Congress, showed that completion of the KickStart30 program was associated with improvements on a variety of wellness measures, including happiness (30%), enthusiasm (51%), resilience 63%, and optimism (45%), she said.

Participants also experienced important improvements in disease markers, including depression (43% based on the 9-item Patient Health Questionnaire), anxiety (40% as measured by the 7-item Generalized Anxiety Disorder scale), and sleep quality (29% based on the 9-item Pittsburgh Sleep Quality Index).

“The one thing I want when you leave and you think about this session is a feeling ... that ‘there are actually things that I can do to improve my wellness.’ There’s something about the power, the synergy between the elements ... it’s reigniting the flame, the interest in wellness,” she said, adding that taking care of others requires “learning to take better care of ourselves.”

“We have to walk the walk of wellness; we cannot simply sit in the ivory tower and talk about it,” she said. “To be genuine and to really engage our patients, we have to walk the walk.”

Dr. Jain is cofounder of the WILD 5 Wellness program, and has served on advisory boards or panels for numerous pharmaceutical companies and other organizations.

sworcester@mdedge.com