Dermatology News

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

A version of this article first appeared on WebMD.com.

This article was updated 7/13/23.

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

A version of this article first appeared on WebMD.com.

This article was updated 7/13/23.

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

A version of this article first appeared on WebMD.com.

This article was updated 7/13/23.

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

A version of this article first appeared on Medscape.com.

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

A version of this article first appeared on Medscape.com.

SINGAPORE – Treatment with an investigational oral interleukin-23 receptor (IL-23R) antagonist peptide – currently known as JNJ-2113 – significantly improved skin lesions in patients with moderate to severe plaque psoriasis across all doses, compared with placebo, according to results of the FRONTIER 1 trial.

In the 16-week phase 2b study, 255 adults with moderate to severe plaque psoriasis were randomly assigned into six treatment groups: placebo (n = 43), JNJ-2113 25 mg daily (n = 43), 25 mg twice daily (n = 41), 50 mg daily (n = 43), 100 mg daily (n = 43), or 100 mg twice daily (n = 42).

Of those who took the placebo, only 9.3% achieved the study’s primary endpoint of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI-75) by week 16. This was compared with 78.6% in the group that took the highest dose.

Sandy Ong, MDedge

“Additionally, the onset of action was fairly fast: at week 4, more than 20% of patients had achieved PASI 75,” said Robert Bissonnette, MD, CEO of Innovaderm Research in Montreal, who presented the findings during a late-breaker session at the World Congress of Dermatology.

Patients in the remaining groups demonstrated a response that corresponded to dosing level: with 37.2%, 51.2%, 58.1%, and 65.1% achieving PASI-75 in the 25 mg daily, 25 mg twice-daily, 50 mg daily, and 100 mg daily groups, respectively.

“These results are very interesting because in terms of psoriasis treatment, if this is confirmed in phase 3, it would give us an oral alternative that would be selective for IL-23,” said Dr. Bissonnette, referring to the signaling pathway that plays a critical role in the pathogenesis of several immune-mediated inflammatory diseases, including plaque psoriasis.

Although rarely life-threatening, the skin disorder is often intractable to treatment. In recent years, therapies that block IL-23 signaling and downstream inflammatory cytokine production have proven useful. “We have on the market a number of biological agents targeting IL-23 that we use on a regular basis,” said Dr. Bissonnette. “However, there are currently no orally delivered therapies.”

If successful, JNJ-2113 – a first-in-class oral IL-23 antagonist peptide developed by Janssen – could change the treatment paradigm for patients with moderate to severe plaque psoriasis. “When I was first introduced to the concept, I thought it wouldn’t work as it’s a peptide, that it would be digested by the stomach,” he told the audience. “But because of its GI stability and its potency, when you administer it orally, you can detect pharmacological activity.”
 

A well-tolerated alternative

Participants in the FRONTIER 1 trial were on average about 44 years old and weighed 88.9 kg (195 lb). Most had been living with psoriasis for about 18 years, with a total PASI score of 19.05. In addition, 43.1% had been treated with phototherapy in the past, 22% with biologics, and 78.4% with systemics.

PASI 90 and 100 were among some of the secondary outcomes measured. Similar to the primary outcome of PASI 75, all treatment groups demonstrated a statistically significant dose-response in PASI 90, compared with placebo. For those on the highest dose of JNJ-2113, 59.5% and 40.5% achieved PASI 90 and PASI 100, respectively, by week 16. The corresponding figures for those receiving placebo were 2.3% and 0%.

The safety profile for JNJ-2113 across all doses was similar to that of placebo, with no evidence of a dose-dependent increase in the occurrence of adverse events (AEs). The most frequently reported AEs were COVID-19 and nasopharyngitis. There were three serious AEs (COVID-19, infected cyst, suicide attempt) among those on the active drug, but the investigators assessed that they were not related to the study intervention. No deaths, major adverse cardiac events, or malignancies were reported during the study.

Approached for an independent comment, Marius-Anton Ionescu, MD, PhD, from the University Hospital Saint Louis, Paris, who specializes in psoriasis, told this news organization that the new development with JNJ-2113 “is really promising.”

Treatment for plaque psoriasis has improved to the point where some biologics, such as risankizumab (Skyrizi), only require patients to have “four shots a year,” he says. “This is the future of psoriasis treatment; it might go down to two shots a year” – a regimen that will be easier than taking an oral medication once or twice a day.

“But it’s good to have an oral option because you will always have some patients who say: ‘Shots are not for me, I’m afraid,’ ” he says.

However, Dr. Ionescu noted that if JNJ-2113 were to pass phase 3 trials, it might face stiff competition from the selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu), which the U.S. Food and Drug Administration approved for use in adults with moderate to severe plaque psoriasis last September. “It has very good results and is the first oral therapy that is comparable with biologics for plaque psoriasis,” he says.

But Dr. Bissonnette remains hopeful for the future. “I think JNJ-2113 goes way beyond psoriasis because this type of strategy using oral peptide–blocking receptors could be used in other immune-mediated diseases, including atopic dermatitis and other diseases outside of dermatology.” In addition to running a phase 3 study for moderate to severe plaque psoriasis, Janssen is planning to initiate a phase 2b clinical trial of JNJ-2113 in adults with ulcerative colitis.

The study was funded by Janssen. Dr. Bissonnette reports consulting and investigating for Janssen, and being on advisory panels and receiving research funding from multiple other pharmaceutical companies. Dr. Ionescu is an investigator for Psoriasis National Register France Psobioteq (no honoraria), and an investigator and speaker for Uriage cosmetics (honoraria).

A version of this article first appeared on Medscape.com.

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

SINGAPORE – Three oral Janus kinase (JAK) inhibitors – abrocitinib, baricitinib, and upadacitinib – have demonstrated a good treatment response in Asian patients with atopic dermatitis (AD), a small retrospective study conducted in Singapore has found.

“Abrocitinib and upadacitinib surprisingly appeared to have better treatment efficacy compared to baricitinib,” said study lead Yik Weng Yew, MD, PhD, MPH, deputy head of research at Singapore’s National Skin Centre (NSC), who presented the results at the 25th World Congress of Dermatology. “But overall, as a group, I think they show a very good treatment response, as well as a good effect on itch response.”

Sandy Ong

JAK inhibitors are used to treat a variety of inflammatory diseases including alopecia areata, rheumatoid arthritis, and inflammatory bowel disease. Although treatment for severe eczema was previously limited to topical steroids and oral immunosuppressants, there are now two oral JAK inhibitors – abrocitinib and upadacitinib – approved in 2022 by the Food and Drug Administration for treating AD, which affects up to 2.4% of the global population. (A topical formulation of ruxolitinib, a JAK inhibitor, was approved for AD in 2021.)

The Singapore study is one of the few that have examined the safety and efficacy of JAK inhibitors for treatment of AD in a non-White population.
 

Chinese population

For the 12-week trial, conducted in 2022, Dr. Yew and associates recruited 35 patients from the NSC. More than half of participants (64%) were men and most (96%) were of Chinese ethnicity. Four of every five patients had previously received systemic agents: 17% had been treated with one systemic agent, 18.9% with two, 15.1% with three, 22.6% with four, and 3.8% with five. The most commonly used agents were cyclosporine (62.3%), methotrexate (47.2%), azathioprine (39.6%), and dupilumab (35.8%).  

“The switch in therapy could have been a result of inadequate efficacy or cost reasons because in Singapore patients pay out of pocket for AD treatments,” said Dr. Yew.

Additionally, he offered a caveat on the profile of participants: “Perhaps they were more difficult atopic eczema patients, and therefore, the efficacy [of JAK inhibitors] might be a bit different.”
 

Clearer skin, less itch

Patients received one of the three study drugs: baricitinib (66%), abrocitinib (21%), and upadacitinib (13%). The distribution was “affected by reimbursement patterns and availability of the drug,” explained Dr. Yew.

They were assessed at weeks 4 and 12. By study end, the proportion of patients who self-reported an improvement in their condition was 100% for upadacitinib, 90% for abrocitinib, and 69% for baricitinib. 

Scores on the Investigator Global Assessment (IGA) also improved with treatment. Patients in the baricitinib group saw their mean score fall from 4.0 to 3.0 by week 4, then to 2.0 by week 12. With upadacitinib and abrocitinib, “you can see that there is a nice decrease in IGA responses,” said Dr. Yew, referring to the larger improvement in scores experienced by patients on those two treatments. For patients on upadacitinib, IGA decreased from 3.5 to 2 at 4 weeks, then to 0.5 at 12 weeks, while those taking abrocitinib had their scores drop from 4.0 to 2.0 at 4 weeks, then to 1.0 at 12 weeks.

When it came to itch reduction, the abrocitinib group experienced the biggest reduction, with a median reduction of 5.5 points in itch score. Median reduction in itch score was 4 points for the other two groups. “Oral JAK inhibitors appear to have a good effect on itch response,” said Dr. Yew.

However, the researchers observed no significant reduction in percentage of body surface area affected, the last outcome assessed.

The most commonly reported adverse events were increased creatine kinase levels (11.3% of patients), increased LDL cholesterol levels (9.4%), and herpes zoster (9.4%). Those in the abrocitinib reported a higher number of these adverse events, compared with the other two treatment groups. (There were no herpes zoster cases among those taking baricitinib.)

For herpes zoster, Dr. Yew said “the common recommendation” is to give the inactivated shingles vaccine. “But the problem is that, number one, these patients would have probably failed multiple agents so they probably can’t wait for you to vaccinate before you initiate treatment.”

In addition, people in Singapore have to pay out-of-pocket for the two vaccine doses, “which is probably a month’s worth of medication,” he noted. “So we have a lot of resistance from patients.”

Additionally, Dr. Yew noted that contrary to what has previously been reported in the literature, there were few complaints of acne as a side effect in the Singaporean study population.
 

Toward greater representation

Dr. Yew pointed out that the study was limited by a few factors: neither the Eczema Area and Severity Index or Scoring of Atopic Dermatitis index data was used, and the study population was small and not representative of the real world.

Still, the new findings contribute to the overall safety and efficacy profile of JAK inhibitors in AD, which has so far been scarce in non-White populations.

“In Western studies, unfortunately, the representation of the population of skin of color or different ethnicities is underrepresented,” said Yousef Binamer, MD, chair of the dermatology department at King Faisal Specialist Hospital, Riyadh, Saudi Arabia, when approached for an independent comment on the results.

“This is now why researchers are looking into specific groups to study them,” which he pointed out, is crucial because “the immunophenotyping of AD is different for each background.”

The incidence and severity of AD tend to be higher in Asian and Middle Eastern populations, for instance, he noted. “It’s very common in Asia, and not so common in very white skin. I did my training in Canada so I see the difference,” said Dr. Binamer. “Asian people tend to be more itchy and have a tendency to scar on pigmentation.” Whereas White people “usually do not have this issue.” 

“So I think real-world evidence of JAK inhibitors in the other populations is important,” he said. Studies such as the one conducted in Singapore, as well as the recently reported QUARTZ3 study, which examined the use of the JAK inhibitor ivarmacitinib in 256 Chinese patients with AD, are helping to pave the way.

The study was independently supported. Dr. Yew and Dr. Binamer have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

SINGAPORE – When injected subcutaneously, the interleukin-36 receptor antagonist spesolimab significantly reduced the risk for generalized pustular psoriasis (GPP) flares, according to results of a study presented in a late-breaker session at the World Congress of Dermatology,

In the phase 2b study, patients who received the high-dose regimen (a 600-mg subcutaneous loading dose, then 300-mg SC every 4 weeks) of spesolimab experienced 84% fewer GPP fares over 48 weeks, compared with those on placebo, reported Bruce Strober, MD, PhD, Central Connecticut Dermatology, Cromwell, and clinical professor of dermatology, Yale University, New Haven, Conn. “Additionally, no flares occurred after week 4, and this, in turn, translated into improved patient outcomes.”

GPP is a rare, chronic, systemic neutrophilic skin disease. The resulting flares, characterized by painful pustules all over the body, can lead to sepsis, shock, and other life-threatening complications. “People who have it are considerably burdened by it, so targeted therapy of this disease is incredibly important because it leads to lessened morbidity and, importantly, mortality for these patients,” Dr. Strober said.

“It’s important not only to treat the flares but also to prevent them,” he noted.

The intravenous formulation of spesolimab (Spevigo) was approved for the treatment of GPP flares in adults by the Food and Drug Administration in September 2022. It is now authorized in nearly 40 countries, including Japan, China, and the European Union.

The phase 2 Effisayil 2 study presented at the meeting evaluated the subcutaneous formulation of spesolimab. Data on subcutaneous spesolimab has been submitted to the FDA, and has received breakthrough therapy designation, according to the manufacturer, Boehringer Ingelheim.

Flare prevention

In the study, 123 patients with GPP were randomly assigned 1:1:1:1 to one of four groups: high-dose spesolimab, medium-dose (600-mg SC loading dose, then 300-mg SC every 12 weeks), low-dose (300-mg SC loading dose, then 150-mg SC every 12 weeks), or placebo. In the event of a flare during the randomized treatment period, a patient was administered a single, 900-mg intravenous dose of spesolimab.

Nearly two-thirds of the participants were female and nearly two-thirds were Asian, with a mean age of about 39-43 years.

The mean numbers of GPP flares experienced annually by those in the low-, medium-, and high-dose spesolimab groups were 2.7, 1.9, and 2.4, respectively (2.4% in the placebo group). Fewer than a third had concurrent plaque psoriasis at baseline. Most (48.4%-63.3%) did not have an IL-36RN mutation.

Additionally, the Generalized Pustular Psoriasis Physician Global Assessment total score was 1 in 74.2%-93.5% of participants, and 0 in the remainder.

The primary study endpoint was the time to GPP flare by week 48. The risk of developing a flare among those on high-dose spesolimab was 84% lower, compared with that of those on placebo (hazard ratio, 0.16; 95% confidence interval, 0.05-0.54; P = .0005). No patients on the high dose had a flare after the 4th week of the study.

Similarly, for the secondary endpoint (occurrence of at least one GPP flare by week 48). Dr. Strober and his colleagues reported that high-dose spesolimab was superior to placebo with a risk difference of -39% (95% CI, –0.62 to –0.16; P = .0013). By contrast, the risk differences for the medium- and low-dose spesolimab arms were –0.23 (95% CI, –0.46 to 0.01) and -0.31 (95% CI, –0.54 to –0.08), respectively.

The safety profile of subcutaneous spesolimab across all three doses was similar to that of placebo, and there was no dose-dependent trend. Reported adverse events (AEs) were mild. There were five (5.4%) AEs leading to discontinuation of the drug in the medium- and high-dose groups, but none in the low-dose group. Overall, there were nine (9.7%) serious AEs reported in the spesolimab groups, and three (10%) in the high-dose group; no deaths occurred on any dose.

Participants most often reported injection-site erythema, reported in 13 (14%) of the patients on spesolimab versus 1 (3.3%) of those on placebo.

“Overall, the study demonstrates that subcutaneous spesolimab is effective at controlling GPP flares, especially at a high dose relative to placebo, and supports subcutaneous spesolimab for the therapy for GPP flare prevention,” Dr. Strober said at the meeting.
 

Targeting the IL-36 pathway

In a comment, Todd Schlesinger, MD, Clinical Research Center of the Carolinas, Charleston, S.C., who moderated the session, said: “It’s very exciting to be able to have a subcutaneous version of the medication.”

“I think the IL-36 is a great pathway,” he said, referring to the signaling pathway within the immune system that is central to the pathogenesis of GPP and several other autoinflammatory diseases.

However, Dr. Schlesinger said that he would have liked to have seen data on how many patients ended up treated with intravenous spesolimab.

He added that he would like future studies of subcutaneous spesolimab to examine the effect in different populations that vary by parameters such as weight, race, and disease severity. “Just seeing how somebody who’s flaring five times a year and you give them this medication and they’re now flaring once a year – that’s interesting data that we might like to know in the future.”

Other than for preventing GPP flares, spesolimab is being studied for treating other IL-36–mediated skin diseases, such as palmoplantar pustulosis.

The study was funded by Boehringer Ingelheim; both Dr. Strober and Dr. Schlesinger do research and consulting for BI, and receive funding from multiple other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

A version of this article first appeared on Medscape.com.

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

A version of this article first appeared on Medscape.com.

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

A version of this article first appeared on Medscape.com.

Flares of systemic lupus erythematosus (SLE), particularly those involving severe kidney disease, were associated with growth spikes of the gut bacteria Ruminococcus blautia gnavus in a small, 4-year observational study that also demonstrated an underlying, inherent instability in the gut microbiome of patients with SLE.

Of 16 patients with SLE studied during the provision of routine care and monitoring, 5 had R. gnavus blooms that were “strikingly concordant with periods of raised disease activity,” Gregg J. Silverman, MD, of NYU Grossman School of Medicine, New York, and coinvestigators reported in Annals of the Rheumatic Diseases.

Four of the five patients with flare-associated R. gnavus blooms had lupus nephritis (LN); the other had a flare involving inflammation in multiple joints. The four patients with concurrent LN and spikes in R. gnavus also represented almost half of patients who had LN disease flares (four of nine) during the study period. The nine patients in the study with renal involvement, and the four with concurrent R. gnavus spikes and flares, represented different races and ethnicities.

The findings build upon research published by the NYU group several years ago showing that patients with SLE had more R. gnavus in the gut than similar patients without the disease, and that flares closely tracked major increases in R. gnavus growth. Evidence of R. gnavus expansions in patients with SLE now comes from several cohorts in the United States as well as cohorts in Europe and China, the researchers noted in their new paper.
 

An underlying, unstable microbiome

The new study at NYU took a “deeper dive” than previous research, looking at individuals over a longer period of time, Dr. Silverman, the study’s senior investigator and associate director of rheumatology at NYU Langone Health, said in an interview. Blood and a total of 44 stool samples from the 16 patients were analyzed, as were a total of 72 stool samples from 22 healthy control volunteers.

Importantly, he said, the gut microbiome in patients with SLE was found to be inherently unstable over time, compared with the microbiota communities of the controls. “There was an instability, a shifting dynamic composition of the microbiome [in patients with lupus]. ... Healthy individuals had more of a balance, with small changes over time” and a stable, low abundance of R. gnavus, Dr. Silverman said.

Transient expansions of several pathogenic species occurred in some of the patients with lupus (and not in controls), but blooms of R. gnavus were the most common. The researchers said in their paper that they “speculate that susceptibility for specific clinical features during R. gnavus blooms reflect in part differences in genetic susceptibility of the patient.”

Patients on cytotoxic agents or antibiotics were excluded from the study, but the study was not designed to disentangle the potential influence of diet or prior antibiotic exposure, they noted. Larger studies are needed that are better controlled and that include more frequent assessments, Dr. Silverman added.
 

A sure association and probable cause

“There seems to be a special connection [of R. gnavus] to lupus nephritis, which is an important, major subset of disease,” said Martin Kriegel, MD, PhD, chief or rheumatology and clinical immunology at the University of Munster (Germany). Dr. Kriegel also researches the gut microbiome in lupus and was asked to comment on the new findings from NYU.

The “difficult question is, is the bug driving the flare [as the NYU paper proposes], or is it the lupus nephritis that leads to overgrowth?” he said, noting that it “is well known that kidney disease, whether from lupus or other causes, creates disturbances in the microbiome.”

It’s “likely the case” that the pathobiome – with R. gnavus being an important pathobiont – helps to drive flares, he said. The new research shows only an association, but studies done in mice – including prior research by Dr. Silverman – support a mechanistic link, said Dr. Kriegel, also adjunct associate professor of immunobiology and of medicine at Yale University, New Haven, Conn.

Investigators in the microbiome space are moving toward more strain-level analysis – “not only measuring what organisms are there, but culturing them and sequencing them,” Dr. Kriegel noted, and the new study does just this.

The R. gnavus strains isolated during lupus flares were distinguishable from strains found in healthy people – and from strains found by other researchers in patients with inflammatory bowel disease – by their common expression of a novel type of cell membrane–associated lipoglycan. The lipoglycans were recognized by specific serum IgG2 antibodies that were detected concurrently with R. gnavus blooms and lupus flares, Dr. Silverman and his colleagues reported.

Dr. Silverman and Dr. Kriegel both study the paradigm of a gut-barrier breach, whereby pathogenic bacteria cause intestinal permeability, allowing bacterial leakages that trigger inflammation and immune responses. “We think that in lupus and other rheumatic diseases like rheumatoid arthritis, a leaky gut barrier is an important mechanism, even though these patients don’t have gastrointestinal symptoms,” said Dr. Kriegel, who has studied the role of another potentially pathogenic bacteria, Enterococcus gallinarum, in SLE.

Strengthening the gut barrier may be a plausible, general approach to reducing the severity of diseases like SLE and RA until more personalized approaches targeting individuals’ microbiome are developed, he noted.

Future treatments involving antibacterial agents, probiotics or dietary regimens that prevent imbalances in the gut microbiome would be “benign,” compared with currently utilized immunosuppressive medications, Dr. Silverman said.

The NYU study was funded in part by grants from the National Institutes of Health and the Lupus Research Alliance. Dr. Silverman disclosed that NYU has filed a patent application for an antibody test to detect serum antibodies to the lipoglycan made by some strains of R. gnavus. Dr. Kriegel disclosed that he holds a patent at Yale related to the Enterococcus bacteria he studies, and that he consults for Roche, Enterome, and Eligo Biosciences.

Flares of systemic lupus erythematosus (SLE), particularly those involving severe kidney disease, were associated with growth spikes of the gut bacteria Ruminococcus blautia gnavus in a small, 4-year observational study that also demonstrated an underlying, inherent instability in the gut microbiome of patients with SLE.

Of 16 patients with SLE studied during the provision of routine care and monitoring, 5 had R. gnavus blooms that were “strikingly concordant with periods of raised disease activity,” Gregg J. Silverman, MD, of NYU Grossman School of Medicine, New York, and coinvestigators reported in Annals of the Rheumatic Diseases.

Four of the five patients with flare-associated R. gnavus blooms had lupus nephritis (LN); the other had a flare involving inflammation in multiple joints. The four patients with concurrent LN and spikes in R. gnavus also represented almost half of patients who had LN disease flares (four of nine) during the study period. The nine patients in the study with renal involvement, and the four with concurrent R. gnavus spikes and flares, represented different races and ethnicities.

The findings build upon research published by the NYU group several years ago showing that patients with SLE had more R. gnavus in the gut than similar patients without the disease, and that flares closely tracked major increases in R. gnavus growth. Evidence of R. gnavus expansions in patients with SLE now comes from several cohorts in the United States as well as cohorts in Europe and China, the researchers noted in their new paper.
 

An underlying, unstable microbiome

The new study at NYU took a “deeper dive” than previous research, looking at individuals over a longer period of time, Dr. Silverman, the study’s senior investigator and associate director of rheumatology at NYU Langone Health, said in an interview. Blood and a total of 44 stool samples from the 16 patients were analyzed, as were a total of 72 stool samples from 22 healthy control volunteers.

Importantly, he said, the gut microbiome in patients with SLE was found to be inherently unstable over time, compared with the microbiota communities of the controls. “There was an instability, a shifting dynamic composition of the microbiome [in patients with lupus]. ... Healthy individuals had more of a balance, with small changes over time” and a stable, low abundance of R. gnavus, Dr. Silverman said.

Transient expansions of several pathogenic species occurred in some of the patients with lupus (and not in controls), but blooms of R. gnavus were the most common. The researchers said in their paper that they “speculate that susceptibility for specific clinical features during R. gnavus blooms reflect in part differences in genetic susceptibility of the patient.”

Patients on cytotoxic agents or antibiotics were excluded from the study, but the study was not designed to disentangle the potential influence of diet or prior antibiotic exposure, they noted. Larger studies are needed that are better controlled and that include more frequent assessments, Dr. Silverman added.
 

A sure association and probable cause

“There seems to be a special connection [of R. gnavus] to lupus nephritis, which is an important, major subset of disease,” said Martin Kriegel, MD, PhD, chief or rheumatology and clinical immunology at the University of Munster (Germany). Dr. Kriegel also researches the gut microbiome in lupus and was asked to comment on the new findings from NYU.

The “difficult question is, is the bug driving the flare [as the NYU paper proposes], or is it the lupus nephritis that leads to overgrowth?” he said, noting that it “is well known that kidney disease, whether from lupus or other causes, creates disturbances in the microbiome.”

It’s “likely the case” that the pathobiome – with R. gnavus being an important pathobiont – helps to drive flares, he said. The new research shows only an association, but studies done in mice – including prior research by Dr. Silverman – support a mechanistic link, said Dr. Kriegel, also adjunct associate professor of immunobiology and of medicine at Yale University, New Haven, Conn.

Investigators in the microbiome space are moving toward more strain-level analysis – “not only measuring what organisms are there, but culturing them and sequencing them,” Dr. Kriegel noted, and the new study does just this.

The R. gnavus strains isolated during lupus flares were distinguishable from strains found in healthy people – and from strains found by other researchers in patients with inflammatory bowel disease – by their common expression of a novel type of cell membrane–associated lipoglycan. The lipoglycans were recognized by specific serum IgG2 antibodies that were detected concurrently with R. gnavus blooms and lupus flares, Dr. Silverman and his colleagues reported.

Dr. Silverman and Dr. Kriegel both study the paradigm of a gut-barrier breach, whereby pathogenic bacteria cause intestinal permeability, allowing bacterial leakages that trigger inflammation and immune responses. “We think that in lupus and other rheumatic diseases like rheumatoid arthritis, a leaky gut barrier is an important mechanism, even though these patients don’t have gastrointestinal symptoms,” said Dr. Kriegel, who has studied the role of another potentially pathogenic bacteria, Enterococcus gallinarum, in SLE.

Strengthening the gut barrier may be a plausible, general approach to reducing the severity of diseases like SLE and RA until more personalized approaches targeting individuals’ microbiome are developed, he noted.

Future treatments involving antibacterial agents, probiotics or dietary regimens that prevent imbalances in the gut microbiome would be “benign,” compared with currently utilized immunosuppressive medications, Dr. Silverman said.

The NYU study was funded in part by grants from the National Institutes of Health and the Lupus Research Alliance. Dr. Silverman disclosed that NYU has filed a patent application for an antibody test to detect serum antibodies to the lipoglycan made by some strains of R. gnavus. Dr. Kriegel disclosed that he holds a patent at Yale related to the Enterococcus bacteria he studies, and that he consults for Roche, Enterome, and Eligo Biosciences.

Flares of systemic lupus erythematosus (SLE), particularly those involving severe kidney disease, were associated with growth spikes of the gut bacteria Ruminococcus blautia gnavus in a small, 4-year observational study that also demonstrated an underlying, inherent instability in the gut microbiome of patients with SLE.

Of 16 patients with SLE studied during the provision of routine care and monitoring, 5 had R. gnavus blooms that were “strikingly concordant with periods of raised disease activity,” Gregg J. Silverman, MD, of NYU Grossman School of Medicine, New York, and coinvestigators reported in Annals of the Rheumatic Diseases.

Four of the five patients with flare-associated R. gnavus blooms had lupus nephritis (LN); the other had a flare involving inflammation in multiple joints. The four patients with concurrent LN and spikes in R. gnavus also represented almost half of patients who had LN disease flares (four of nine) during the study period. The nine patients in the study with renal involvement, and the four with concurrent R. gnavus spikes and flares, represented different races and ethnicities.

The findings build upon research published by the NYU group several years ago showing that patients with SLE had more R. gnavus in the gut than similar patients without the disease, and that flares closely tracked major increases in R. gnavus growth. Evidence of R. gnavus expansions in patients with SLE now comes from several cohorts in the United States as well as cohorts in Europe and China, the researchers noted in their new paper.
 

An underlying, unstable microbiome

The new study at NYU took a “deeper dive” than previous research, looking at individuals over a longer period of time, Dr. Silverman, the study’s senior investigator and associate director of rheumatology at NYU Langone Health, said in an interview. Blood and a total of 44 stool samples from the 16 patients were analyzed, as were a total of 72 stool samples from 22 healthy control volunteers.

Importantly, he said, the gut microbiome in patients with SLE was found to be inherently unstable over time, compared with the microbiota communities of the controls. “There was an instability, a shifting dynamic composition of the microbiome [in patients with lupus]. ... Healthy individuals had more of a balance, with small changes over time” and a stable, low abundance of R. gnavus, Dr. Silverman said.

Transient expansions of several pathogenic species occurred in some of the patients with lupus (and not in controls), but blooms of R. gnavus were the most common. The researchers said in their paper that they “speculate that susceptibility for specific clinical features during R. gnavus blooms reflect in part differences in genetic susceptibility of the patient.”

Patients on cytotoxic agents or antibiotics were excluded from the study, but the study was not designed to disentangle the potential influence of diet or prior antibiotic exposure, they noted. Larger studies are needed that are better controlled and that include more frequent assessments, Dr. Silverman added.
 

A sure association and probable cause

“There seems to be a special connection [of R. gnavus] to lupus nephritis, which is an important, major subset of disease,” said Martin Kriegel, MD, PhD, chief or rheumatology and clinical immunology at the University of Munster (Germany). Dr. Kriegel also researches the gut microbiome in lupus and was asked to comment on the new findings from NYU.

The “difficult question is, is the bug driving the flare [as the NYU paper proposes], or is it the lupus nephritis that leads to overgrowth?” he said, noting that it “is well known that kidney disease, whether from lupus or other causes, creates disturbances in the microbiome.”

It’s “likely the case” that the pathobiome – with R. gnavus being an important pathobiont – helps to drive flares, he said. The new research shows only an association, but studies done in mice – including prior research by Dr. Silverman – support a mechanistic link, said Dr. Kriegel, also adjunct associate professor of immunobiology and of medicine at Yale University, New Haven, Conn.

Investigators in the microbiome space are moving toward more strain-level analysis – “not only measuring what organisms are there, but culturing them and sequencing them,” Dr. Kriegel noted, and the new study does just this.

The R. gnavus strains isolated during lupus flares were distinguishable from strains found in healthy people – and from strains found by other researchers in patients with inflammatory bowel disease – by their common expression of a novel type of cell membrane–associated lipoglycan. The lipoglycans were recognized by specific serum IgG2 antibodies that were detected concurrently with R. gnavus blooms and lupus flares, Dr. Silverman and his colleagues reported.

Dr. Silverman and Dr. Kriegel both study the paradigm of a gut-barrier breach, whereby pathogenic bacteria cause intestinal permeability, allowing bacterial leakages that trigger inflammation and immune responses. “We think that in lupus and other rheumatic diseases like rheumatoid arthritis, a leaky gut barrier is an important mechanism, even though these patients don’t have gastrointestinal symptoms,” said Dr. Kriegel, who has studied the role of another potentially pathogenic bacteria, Enterococcus gallinarum, in SLE.

Strengthening the gut barrier may be a plausible, general approach to reducing the severity of diseases like SLE and RA until more personalized approaches targeting individuals’ microbiome are developed, he noted.

Future treatments involving antibacterial agents, probiotics or dietary regimens that prevent imbalances in the gut microbiome would be “benign,” compared with currently utilized immunosuppressive medications, Dr. Silverman said.

The NYU study was funded in part by grants from the National Institutes of Health and the Lupus Research Alliance. Dr. Silverman disclosed that NYU has filed a patent application for an antibody test to detect serum antibodies to the lipoglycan made by some strains of R. gnavus. Dr. Kriegel disclosed that he holds a patent at Yale related to the Enterococcus bacteria he studies, and that he consults for Roche, Enterome, and Eligo Biosciences.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

On July 6, the Food and Drug Administration updated its informational webpage on dermal fillers to reflect the risk of delayed-onset inflammation near dermal filler treatment sites.

Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.

“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.

The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”

Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.

Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.

Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

A version of this article originally appeared on Medscape.com.

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

A version of this article originally appeared on Medscape.com.

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

A version of this article originally appeared on Medscape.com.

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

fpnews@mdedge.com

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

fpnews@mdedge.com

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

fpnews@mdedge.com

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.

While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.

Those are among 46 evidence- and consensus-based recommendations about the use of MTX for inflammatory skin disease in pediatric patients that were developed by a committee of 23 experts and published online in Pediatric Dermatology.

“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”

• MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
• Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
• Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
• Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
• Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
• Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
• Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.

According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.

Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.

The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.