Dermatology News

Researchers are reporting impressive results in a small, open-label trial of the JAK inhibitor tofacitinib in cutaneous sarcoidosis: 6 of 10 patients improved so much that they reached a disease activity level of zero, and all patients improved by an average of 83% via a scoring system.

“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.

Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.

“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.


“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”

Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.

Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.

The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.

In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”

Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.

In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.

She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”

The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.

This article was updated 5/5/21.

Researchers are reporting impressive results in a small, open-label trial of the JAK inhibitor tofacitinib in cutaneous sarcoidosis: 6 of 10 patients improved so much that they reached a disease activity level of zero, and all patients improved by an average of 83% via a scoring system.

“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.

Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.

“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.


“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”

Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.

Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.

The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.

In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”

Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.

In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.

She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”

The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.

This article was updated 5/5/21.

Researchers are reporting impressive results in a small, open-label trial of the JAK inhibitor tofacitinib in cutaneous sarcoidosis: 6 of 10 patients improved so much that they reached a disease activity level of zero, and all patients improved by an average of 83% via a scoring system.

“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.

Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.

“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.


“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”

Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.

Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.

The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.

In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”

Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.

In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.

She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”

The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.

This article was updated 5/5/21.

Sofpironium bromide, a new topical anticholinergic agent, appears to be a safer version of glycopyrrolate for the treatment of axillary hyperhidrosis, according to 48-week safety and outcome data.

Koldunov/Thinkstock

A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.

The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.

In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.

The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.

“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”

The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).

At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.

“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.

While response rates climbed over the course of the study, rates of adverse events fell markedly.

After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.

The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.

For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.

These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.

The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.

The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.

In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.

The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.

This article was updated 4/26/21.

Sofpironium bromide, a new topical anticholinergic agent, appears to be a safer version of glycopyrrolate for the treatment of axillary hyperhidrosis, according to 48-week safety and outcome data.

Koldunov/Thinkstock

A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.

The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.

In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.

The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.

“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”

The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).

At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.

“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.

While response rates climbed over the course of the study, rates of adverse events fell markedly.

After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.

The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.

For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.

These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.

The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.

The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.

In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.

The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.

This article was updated 4/26/21.

Sofpironium bromide, a new topical anticholinergic agent, appears to be a safer version of glycopyrrolate for the treatment of axillary hyperhidrosis, according to 48-week safety and outcome data.

Koldunov/Thinkstock

A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.

The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.

In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.

The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.

“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”

The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).

At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.

“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.

While response rates climbed over the course of the study, rates of adverse events fell markedly.

After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.

The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.

For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.

These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.

The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.

The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.

In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.

The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.

This article was updated 4/26/21.

Secukinumab is the latest adult plaque psoriasis treatment to be bested by a newcomer, the interleukin 17A and 17F blocker bimekizumab.

Rates of complete clearance were substantially higher with bimekizumab in a phase 3 trial with 743 patients with moderate-to-severe plaque psoriasis, but oral candidiasis (oral thrush) again emerged as a particular issue with the agent.

Clinical improvements seen with bimekizumab have exceeded those with two standard options for adult plaque psoriasis — the tumor necrosis factor blocker adalimumab and the interleukin (IL) 12/23 inhibitor ustekinumab

 — in phase 3 trials from manufacturer UCB Pharma, and it›s under review for the indication by the U.S. Food and Drug Administration and the European Medicines Agency.

The biologic is also being evaluated in phase 3 trials for treating psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa.

Results of the trial comparing bimekizumab to secukinumab, dubbed BE RADIANT, were presented at the American Academy of Dermatology Virtual Meeting Experience and published online concurrently April 23 in the New England Journal of Medicine.

The results “suggest that inhibition of both interleukin-17A and interleukin-17F with bimekizumab may provide greater clinical benefit for patients with moderate-to-severe plaque psoriasis than inhibition of interleukin-17A alone,” as with secukinumab, said the investigators, led by Kristian Reich, MD,  professor of dermatology at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany.

The trial randomly assigned 373 adults to bimekizumab 320 mg every 4 weeks to week 16, then rerandomized them to maintenance dosing either every 4 weeks or every 8 weeks to week 48; another 370 adults were randomly assigned to secukinumab 300 mg weekly for the first 4 weeks, then every 4 weeks to week 48. Baseline Psoriasis Area and Severity Index (PASI) scores were about 20 points in both treatment groups.

At the 1-month point, 71% in the bimekizumab group, vs 47.3% on secukinumab, had a 75% or greater reduction from their baseline PASI score. At 4 months, 61.7% of those on bimekizumab but 48.9% in the secukinumab group had complete clearance with a PASI score of 100.

At 48 weeks, 67% of those on bimekizumab had a PASI 100 response — which was numerically similar between the two bimekizumab dosing regimens after week 16 — vs 46.2% of the secukinumab group (P for all < .001).

The incidence of serious adverse events was just under 6% in both groups, with adverse events leading to discontinuation in 3.5% of bimekizumab and 2.7% of secukinumab subjects. The rate of serious infections was similar in both groups.

However, as in past trials, oral candidiasis was an issue, occurring in 19.3% of bimekizumab subjects vs 3% on secukinumab. Half of the 72 bimekizumab cases were classified as mild, and all but two of the rest as moderate. Over 40% of affected subjects reported more than one case, but none led to treatment discontinuation.

More than 85% of oral candidiasis cases in the study were treated with antifungal therapy and resolved during the trial. Inflammatory bowel disease is a concern with IL-17 blockade, but this hasn’t emerged as a particular issue with bimekizumab. There was one case each of ulcerative colitis in both the bimekizumab and secukinumab groups, and just one case of ulcerative colitis in three previous phase 3 bimekizumab trials, according to the investigators.

Among the trial limitations: Patients who had been on bimekizumab or secukinumab previously were excluded, as were patients who had no response to an IL-17 biologic or more than one biologic agent of any other class within the previous 12 weeks. The limitations could reduce generalizability, the investigators said.

Patients in the trial were about 45 years old, on average, and about two thirds were men; over 90% were White.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Reich who reported grants and personal fees from companies including UCB Pharma. The full list of disclosures can be found with the New England Journal of Medicine article.

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

Secukinumab is the latest adult plaque psoriasis treatment to be bested by a newcomer, the interleukin 17A and 17F blocker bimekizumab.

Rates of complete clearance were substantially higher with bimekizumab in a phase 3 trial with 743 patients with moderate-to-severe plaque psoriasis, but oral candidiasis (oral thrush) again emerged as a particular issue with the agent.

Clinical improvements seen with bimekizumab have exceeded those with two standard options for adult plaque psoriasis — the tumor necrosis factor blocker adalimumab and the interleukin (IL) 12/23 inhibitor ustekinumab

 — in phase 3 trials from manufacturer UCB Pharma, and it›s under review for the indication by the U.S. Food and Drug Administration and the European Medicines Agency.

The biologic is also being evaluated in phase 3 trials for treating psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa.

Results of the trial comparing bimekizumab to secukinumab, dubbed BE RADIANT, were presented at the American Academy of Dermatology Virtual Meeting Experience and published online concurrently April 23 in the New England Journal of Medicine.

The results “suggest that inhibition of both interleukin-17A and interleukin-17F with bimekizumab may provide greater clinical benefit for patients with moderate-to-severe plaque psoriasis than inhibition of interleukin-17A alone,” as with secukinumab, said the investigators, led by Kristian Reich, MD,  professor of dermatology at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany.

The trial randomly assigned 373 adults to bimekizumab 320 mg every 4 weeks to week 16, then rerandomized them to maintenance dosing either every 4 weeks or every 8 weeks to week 48; another 370 adults were randomly assigned to secukinumab 300 mg weekly for the first 4 weeks, then every 4 weeks to week 48. Baseline Psoriasis Area and Severity Index (PASI) scores were about 20 points in both treatment groups.

At the 1-month point, 71% in the bimekizumab group, vs 47.3% on secukinumab, had a 75% or greater reduction from their baseline PASI score. At 4 months, 61.7% of those on bimekizumab but 48.9% in the secukinumab group had complete clearance with a PASI score of 100.

At 48 weeks, 67% of those on bimekizumab had a PASI 100 response — which was numerically similar between the two bimekizumab dosing regimens after week 16 — vs 46.2% of the secukinumab group (P for all < .001).

The incidence of serious adverse events was just under 6% in both groups, with adverse events leading to discontinuation in 3.5% of bimekizumab and 2.7% of secukinumab subjects. The rate of serious infections was similar in both groups.

However, as in past trials, oral candidiasis was an issue, occurring in 19.3% of bimekizumab subjects vs 3% on secukinumab. Half of the 72 bimekizumab cases were classified as mild, and all but two of the rest as moderate. Over 40% of affected subjects reported more than one case, but none led to treatment discontinuation.

More than 85% of oral candidiasis cases in the study were treated with antifungal therapy and resolved during the trial. Inflammatory bowel disease is a concern with IL-17 blockade, but this hasn’t emerged as a particular issue with bimekizumab. There was one case each of ulcerative colitis in both the bimekizumab and secukinumab groups, and just one case of ulcerative colitis in three previous phase 3 bimekizumab trials, according to the investigators.

Among the trial limitations: Patients who had been on bimekizumab or secukinumab previously were excluded, as were patients who had no response to an IL-17 biologic or more than one biologic agent of any other class within the previous 12 weeks. The limitations could reduce generalizability, the investigators said.

Patients in the trial were about 45 years old, on average, and about two thirds were men; over 90% were White.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Reich who reported grants and personal fees from companies including UCB Pharma. The full list of disclosures can be found with the New England Journal of Medicine article.

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

Secukinumab is the latest adult plaque psoriasis treatment to be bested by a newcomer, the interleukin 17A and 17F blocker bimekizumab.

Rates of complete clearance were substantially higher with bimekizumab in a phase 3 trial with 743 patients with moderate-to-severe plaque psoriasis, but oral candidiasis (oral thrush) again emerged as a particular issue with the agent.

Clinical improvements seen with bimekizumab have exceeded those with two standard options for adult plaque psoriasis — the tumor necrosis factor blocker adalimumab and the interleukin (IL) 12/23 inhibitor ustekinumab

 — in phase 3 trials from manufacturer UCB Pharma, and it›s under review for the indication by the U.S. Food and Drug Administration and the European Medicines Agency.

The biologic is also being evaluated in phase 3 trials for treating psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa.

Results of the trial comparing bimekizumab to secukinumab, dubbed BE RADIANT, were presented at the American Academy of Dermatology Virtual Meeting Experience and published online concurrently April 23 in the New England Journal of Medicine.

The results “suggest that inhibition of both interleukin-17A and interleukin-17F with bimekizumab may provide greater clinical benefit for patients with moderate-to-severe plaque psoriasis than inhibition of interleukin-17A alone,” as with secukinumab, said the investigators, led by Kristian Reich, MD,  professor of dermatology at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany.

The trial randomly assigned 373 adults to bimekizumab 320 mg every 4 weeks to week 16, then rerandomized them to maintenance dosing either every 4 weeks or every 8 weeks to week 48; another 370 adults were randomly assigned to secukinumab 300 mg weekly for the first 4 weeks, then every 4 weeks to week 48. Baseline Psoriasis Area and Severity Index (PASI) scores were about 20 points in both treatment groups.

At the 1-month point, 71% in the bimekizumab group, vs 47.3% on secukinumab, had a 75% or greater reduction from their baseline PASI score. At 4 months, 61.7% of those on bimekizumab but 48.9% in the secukinumab group had complete clearance with a PASI score of 100.

At 48 weeks, 67% of those on bimekizumab had a PASI 100 response — which was numerically similar between the two bimekizumab dosing regimens after week 16 — vs 46.2% of the secukinumab group (P for all < .001).

The incidence of serious adverse events was just under 6% in both groups, with adverse events leading to discontinuation in 3.5% of bimekizumab and 2.7% of secukinumab subjects. The rate of serious infections was similar in both groups.

However, as in past trials, oral candidiasis was an issue, occurring in 19.3% of bimekizumab subjects vs 3% on secukinumab. Half of the 72 bimekizumab cases were classified as mild, and all but two of the rest as moderate. Over 40% of affected subjects reported more than one case, but none led to treatment discontinuation.

More than 85% of oral candidiasis cases in the study were treated with antifungal therapy and resolved during the trial. Inflammatory bowel disease is a concern with IL-17 blockade, but this hasn’t emerged as a particular issue with bimekizumab. There was one case each of ulcerative colitis in both the bimekizumab and secukinumab groups, and just one case of ulcerative colitis in three previous phase 3 bimekizumab trials, according to the investigators.

Among the trial limitations: Patients who had been on bimekizumab or secukinumab previously were excluded, as were patients who had no response to an IL-17 biologic or more than one biologic agent of any other class within the previous 12 weeks. The limitations could reduce generalizability, the investigators said.

Patients in the trial were about 45 years old, on average, and about two thirds were men; over 90% were White.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Reich who reported grants and personal fees from companies including UCB Pharma. The full list of disclosures can be found with the New England Journal of Medicine article.

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

For pain related to skin disorders, dermatologists should generally consider management as their direct responsibility without referrals, according to an expert who outlined his strategies at the American Academy of Dermatology Virtual Meeting Experience.

The exceptions relate primarily to patients with issues complicating pain control, such as those with psychosocial problems exacerbating the pain response, drug-seeking behavior, or both, according to Robert G. Micheletti, MD, chief of hospital dermatology, University of Pennsylvania, Philadelphia.

To stay out of trouble, Dr. Micheletti advocated a systematic approach to the control of pain that includes documentation, clear expectations, and a sparing use of opioids only at the lowest acceptable dose for periods measured in days.

Using a case of pyoderma gangrenosum to make several points, he recognized that some patients do have a level of pain that warrants a short course of opioids, but this is not his first step. Rather, the initial focus, after administering standard therapies for this disease, is wound care, which often attenuates symptoms. He adds non-pharmacologic treatments, such as ice, heat, and rest when appropriate. The initial pharmacologic approach is alternating doses of an NSAID and acetaminophen.

“If necessary, a short course of opioids is reasonable for patients with acute pain,” he acknowledged. But he wants to avoid providing more opioids than needed to address the initial period of acute pain. In the case of pyoderma gangrenosum, he suggested a typical prescription might be 12 pills of 5 mg oxycodone taken every six hours. A followup appointment within a week provides the opportunity to reassess.

“Set clear expectations,” Dr. Micheletti said. This includes explaining that the goal is manageable pain, not complete pain relief, which is often unobtainable. For painful conditions such as pyoderma gangrenosum, hidradenitis suppurativa, or vasculitis, a short course will generally be sufficient to get past the most significant discomfort.

There are several reasons that Dr. Micheletti encourages dermatologists to take responsibility for pain related to skin diseases. One is the potential for inefficiencies and delays common to referrals, but another is the value of the dermatologist’s expertise in judging pain as a symptom of the disorder. With effective treatment, pain should self-resolve.

“If the patient is not getting better medically, then change therapies,” Dr. Micheletti said. When referred to a non-dermatologist, the pain expert might not recognize what persistent pain is revealing about the underlying condition.

Repeatedly, Dr. Micheletti made the point that dermatologists should manage pain related to skin disorders because of their ability to assess complaints in the context of the disease.

“We are the experts. We should understand when what we are seeing should or should not be painful,” he said. He added that dermatologists are also in the best position to judge “when analgesia is no longer needed.”

With this same logic, dermatologists are in a good position to distinguish nociceptive from neuropathic pain. Some conditions are likely to have both, and this should influence choice of pain relief. Citing a patient with calciphylaxis as an example, Dr. Micheletti suggested that drugs with efficacy against neuropathic pain, such as gabapentin, should be one of the options to consider before moving to opioids. In those with sufficient pain to warrant an opioid, however, Dr. Micheletti would consider tramadol, which acts on both types of pain.

Treating pain is not always straightforward, Dr. Micheletti acknowledged. For example, depression and mood disorders are known to exacerbate pain and are reasonable targets of pain control. The stress related to disruptive psychosocial problems can be another factor in risk of pain.

“Be prepared to acknowledge and address these types of issues,” Dr. Micheletti said. Although these are the types of patients some dermatologists might prefer to refer to a pain specialist, he said that the contribution of factors outside of skin disease should not be allowed to obscure a dermatologic source of pain.

“Just because a patient has psychosocial issues does not mean that there is no pain,” he said.

A systematic approach to the assessment and treatment of pain will help sort out these issues, but Dr. Micheletti also said, “Know your comfort zone.” When patients require opioids, there are several appropriate steps important or mandatory to provide adequate protection for the patient and the physician. In addition to documentation, it is reasonable to verify that the patient is not obtaining opioids from other prescribers, a step that is mandatory in some states.

When opioids are needed, Dr. Micheletti suggested a standard approach that includes short courses without refills. He recommended avoiding long-acting opioids and drugs not commonly used by non-pain specialists, such as codeine, hydrocodone, or fentanyl.

“This is not a prescribe and walk away situation,” he said.

Although the same general approach is employed by Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, he is a little less reluctant to refer patients to pain specialists.

“For complex situations, you need complex solutions. In the case of significant pain and even itch, I will collaborate with the GW Pain Center,” he said. For severe pain, the solutions might include nerve blocks or even intravenous ketamine for in-patients.

He also made the point that dermatologists, even if they are uncomfortable prescribing opioids, “should be equipped to use relevant medications such as topical anesthetics, gabapentinoids, and SSRIs” to control pain related to skin conditions.

Dr. Micheletti reports no relevant conflicts of interest. Dr. Friedman has consulting relationships with several pharmaceutical companies, including Amgen, GlaxoSmithKline, and Valeant.

For pain related to skin disorders, dermatologists should generally consider management as their direct responsibility without referrals, according to an expert who outlined his strategies at the American Academy of Dermatology Virtual Meeting Experience.

The exceptions relate primarily to patients with issues complicating pain control, such as those with psychosocial problems exacerbating the pain response, drug-seeking behavior, or both, according to Robert G. Micheletti, MD, chief of hospital dermatology, University of Pennsylvania, Philadelphia.

To stay out of trouble, Dr. Micheletti advocated a systematic approach to the control of pain that includes documentation, clear expectations, and a sparing use of opioids only at the lowest acceptable dose for periods measured in days.

Using a case of pyoderma gangrenosum to make several points, he recognized that some patients do have a level of pain that warrants a short course of opioids, but this is not his first step. Rather, the initial focus, after administering standard therapies for this disease, is wound care, which often attenuates symptoms. He adds non-pharmacologic treatments, such as ice, heat, and rest when appropriate. The initial pharmacologic approach is alternating doses of an NSAID and acetaminophen.

“If necessary, a short course of opioids is reasonable for patients with acute pain,” he acknowledged. But he wants to avoid providing more opioids than needed to address the initial period of acute pain. In the case of pyoderma gangrenosum, he suggested a typical prescription might be 12 pills of 5 mg oxycodone taken every six hours. A followup appointment within a week provides the opportunity to reassess.

“Set clear expectations,” Dr. Micheletti said. This includes explaining that the goal is manageable pain, not complete pain relief, which is often unobtainable. For painful conditions such as pyoderma gangrenosum, hidradenitis suppurativa, or vasculitis, a short course will generally be sufficient to get past the most significant discomfort.

There are several reasons that Dr. Micheletti encourages dermatologists to take responsibility for pain related to skin diseases. One is the potential for inefficiencies and delays common to referrals, but another is the value of the dermatologist’s expertise in judging pain as a symptom of the disorder. With effective treatment, pain should self-resolve.

“If the patient is not getting better medically, then change therapies,” Dr. Micheletti said. When referred to a non-dermatologist, the pain expert might not recognize what persistent pain is revealing about the underlying condition.

Repeatedly, Dr. Micheletti made the point that dermatologists should manage pain related to skin disorders because of their ability to assess complaints in the context of the disease.

“We are the experts. We should understand when what we are seeing should or should not be painful,” he said. He added that dermatologists are also in the best position to judge “when analgesia is no longer needed.”

With this same logic, dermatologists are in a good position to distinguish nociceptive from neuropathic pain. Some conditions are likely to have both, and this should influence choice of pain relief. Citing a patient with calciphylaxis as an example, Dr. Micheletti suggested that drugs with efficacy against neuropathic pain, such as gabapentin, should be one of the options to consider before moving to opioids. In those with sufficient pain to warrant an opioid, however, Dr. Micheletti would consider tramadol, which acts on both types of pain.

Treating pain is not always straightforward, Dr. Micheletti acknowledged. For example, depression and mood disorders are known to exacerbate pain and are reasonable targets of pain control. The stress related to disruptive psychosocial problems can be another factor in risk of pain.

“Be prepared to acknowledge and address these types of issues,” Dr. Micheletti said. Although these are the types of patients some dermatologists might prefer to refer to a pain specialist, he said that the contribution of factors outside of skin disease should not be allowed to obscure a dermatologic source of pain.

“Just because a patient has psychosocial issues does not mean that there is no pain,” he said.

A systematic approach to the assessment and treatment of pain will help sort out these issues, but Dr. Micheletti also said, “Know your comfort zone.” When patients require opioids, there are several appropriate steps important or mandatory to provide adequate protection for the patient and the physician. In addition to documentation, it is reasonable to verify that the patient is not obtaining opioids from other prescribers, a step that is mandatory in some states.

When opioids are needed, Dr. Micheletti suggested a standard approach that includes short courses without refills. He recommended avoiding long-acting opioids and drugs not commonly used by non-pain specialists, such as codeine, hydrocodone, or fentanyl.

“This is not a prescribe and walk away situation,” he said.

Although the same general approach is employed by Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, he is a little less reluctant to refer patients to pain specialists.

“For complex situations, you need complex solutions. In the case of significant pain and even itch, I will collaborate with the GW Pain Center,” he said. For severe pain, the solutions might include nerve blocks or even intravenous ketamine for in-patients.

He also made the point that dermatologists, even if they are uncomfortable prescribing opioids, “should be equipped to use relevant medications such as topical anesthetics, gabapentinoids, and SSRIs” to control pain related to skin conditions.

Dr. Micheletti reports no relevant conflicts of interest. Dr. Friedman has consulting relationships with several pharmaceutical companies, including Amgen, GlaxoSmithKline, and Valeant.

For pain related to skin disorders, dermatologists should generally consider management as their direct responsibility without referrals, according to an expert who outlined his strategies at the American Academy of Dermatology Virtual Meeting Experience.

The exceptions relate primarily to patients with issues complicating pain control, such as those with psychosocial problems exacerbating the pain response, drug-seeking behavior, or both, according to Robert G. Micheletti, MD, chief of hospital dermatology, University of Pennsylvania, Philadelphia.

To stay out of trouble, Dr. Micheletti advocated a systematic approach to the control of pain that includes documentation, clear expectations, and a sparing use of opioids only at the lowest acceptable dose for periods measured in days.

Using a case of pyoderma gangrenosum to make several points, he recognized that some patients do have a level of pain that warrants a short course of opioids, but this is not his first step. Rather, the initial focus, after administering standard therapies for this disease, is wound care, which often attenuates symptoms. He adds non-pharmacologic treatments, such as ice, heat, and rest when appropriate. The initial pharmacologic approach is alternating doses of an NSAID and acetaminophen.

“If necessary, a short course of opioids is reasonable for patients with acute pain,” he acknowledged. But he wants to avoid providing more opioids than needed to address the initial period of acute pain. In the case of pyoderma gangrenosum, he suggested a typical prescription might be 12 pills of 5 mg oxycodone taken every six hours. A followup appointment within a week provides the opportunity to reassess.

“Set clear expectations,” Dr. Micheletti said. This includes explaining that the goal is manageable pain, not complete pain relief, which is often unobtainable. For painful conditions such as pyoderma gangrenosum, hidradenitis suppurativa, or vasculitis, a short course will generally be sufficient to get past the most significant discomfort.

There are several reasons that Dr. Micheletti encourages dermatologists to take responsibility for pain related to skin diseases. One is the potential for inefficiencies and delays common to referrals, but another is the value of the dermatologist’s expertise in judging pain as a symptom of the disorder. With effective treatment, pain should self-resolve.

“If the patient is not getting better medically, then change therapies,” Dr. Micheletti said. When referred to a non-dermatologist, the pain expert might not recognize what persistent pain is revealing about the underlying condition.

Repeatedly, Dr. Micheletti made the point that dermatologists should manage pain related to skin disorders because of their ability to assess complaints in the context of the disease.

“We are the experts. We should understand when what we are seeing should or should not be painful,” he said. He added that dermatologists are also in the best position to judge “when analgesia is no longer needed.”

With this same logic, dermatologists are in a good position to distinguish nociceptive from neuropathic pain. Some conditions are likely to have both, and this should influence choice of pain relief. Citing a patient with calciphylaxis as an example, Dr. Micheletti suggested that drugs with efficacy against neuropathic pain, such as gabapentin, should be one of the options to consider before moving to opioids. In those with sufficient pain to warrant an opioid, however, Dr. Micheletti would consider tramadol, which acts on both types of pain.

Treating pain is not always straightforward, Dr. Micheletti acknowledged. For example, depression and mood disorders are known to exacerbate pain and are reasonable targets of pain control. The stress related to disruptive psychosocial problems can be another factor in risk of pain.

“Be prepared to acknowledge and address these types of issues,” Dr. Micheletti said. Although these are the types of patients some dermatologists might prefer to refer to a pain specialist, he said that the contribution of factors outside of skin disease should not be allowed to obscure a dermatologic source of pain.

“Just because a patient has psychosocial issues does not mean that there is no pain,” he said.

A systematic approach to the assessment and treatment of pain will help sort out these issues, but Dr. Micheletti also said, “Know your comfort zone.” When patients require opioids, there are several appropriate steps important or mandatory to provide adequate protection for the patient and the physician. In addition to documentation, it is reasonable to verify that the patient is not obtaining opioids from other prescribers, a step that is mandatory in some states.

When opioids are needed, Dr. Micheletti suggested a standard approach that includes short courses without refills. He recommended avoiding long-acting opioids and drugs not commonly used by non-pain specialists, such as codeine, hydrocodone, or fentanyl.

“This is not a prescribe and walk away situation,” he said.

Although the same general approach is employed by Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, he is a little less reluctant to refer patients to pain specialists.

“For complex situations, you need complex solutions. In the case of significant pain and even itch, I will collaborate with the GW Pain Center,” he said. For severe pain, the solutions might include nerve blocks or even intravenous ketamine for in-patients.

He also made the point that dermatologists, even if they are uncomfortable prescribing opioids, “should be equipped to use relevant medications such as topical anesthetics, gabapentinoids, and SSRIs” to control pain related to skin conditions.

Dr. Micheletti reports no relevant conflicts of interest. Dr. Friedman has consulting relationships with several pharmaceutical companies, including Amgen, GlaxoSmithKline, and Valeant.

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson

A novel, highly selective oral sphingosine 1-phosphate (S1P)–receptor modulator showed promise as a treatment for atopic dermatitis (AD) in a 12-week phase 2b trial, according to researchers who released their findings at the American Academy of Dermatology Virtual Meeting Experience.

Courtesy Mount Sinai Health System

The drug, called etrasimod, did not meet the primary endpoint for improvement in the Eczema Area and Severity Index. However, nearly a third (29.8%) of those treated with a 2-mg dose daily reached “clear” or “almost clear” skin at 12 weeks vs. 13% for placebo as measured with clinician-reported Validated Investigator Global Assessment (vIGA) scores of 0 or 1 (P = .0450), study presenter Emma Guttman-Yassky, MD, PhD, professor and chair, department of dermatology, Icahn School of Medicine at Mount Sinai, New York, noted in an interview.

“This was a short proof-of-concept study to show this mechanism is valid. The results are promising,” Dr. Guttman-Yassky said. “They tell us that this can be a valid treatment for atopic dermatitis, a completely new mechanism of action that has potential in improving and even modifying the disease.”

Arena Pharmaceuticals, which developed the drug, hopes to launch a phase 3 study of the medication.

The ADVISE study enrolled 140 people in the United States, Australia, and Canada with chronic, moderate to severe eczema lasting for at least a year. (Their average age was 43, 61% were female, and 60% were White). They were randomly assigned to cohorts who took 1 mg or 2 mg daily of etrasimod or placebo for 12 weeks.

Those in the 2-mg cohort saw their scores on the peak pruritus numeric rating scale (PP-NRS) fall by 15.3% at week 4, compared with 1% for placebo (P = .0380); at week 12, the scores fell by 34.1% among those on 2 mg vs. 23.9% for placebo (P = .15 49). At 12 weeks, patients on the 2-mg dose also had more improvement in the Dermatology Life Quality Index or DLQI (a 7.6-point decline in degree of impairment vs. 4.2 points for placebo, P = .0122) and in the Patient-Oriented Eczema Measure or POEM (8.4-point reduction versus 4 points for placebo, P = .0045).

“Basically, there was a dose response. It doesn’t show a plateau,” Dr. Guttman-Yassky said. “ I think the data will be even better in a longer study.”

In regards to adverse events, participants who took etrasimod reported nausea, constipation, back pain, and dizziness at levels above 5% and above the levels for the placebo.

The drug appears to work by preventing immune cells from entering the skin, Dr. Guttman-Yassky said, and may be able to treat existing lesions and prevent new ones from appearing. Etrasimod is also being explored as a treatment for ulcerative colitis, alopecia areata, and multiple sclerosis, she said.

Dr. Guttman-Yassky noted that 12 weeks is a short time in AD, and she said some participants left the study because it took place during the coronavirus pandemic.

“There’s a huge unmet need in atopic dermatitis,” she said. “We need more drugs and different classes of drugs to treat the disease in all patients.” While biologics are often helpful, she said, they don’t work in many cases. And “some patients just don’t want a biologic, no matter how much we tell them it’s safe, and they may want an oral medication,” she said.

Dr. Guttman-Yassky is a paid consultant and researcher for Arena.

A novel, highly selective oral sphingosine 1-phosphate (S1P)–receptor modulator showed promise as a treatment for atopic dermatitis (AD) in a 12-week phase 2b trial, according to researchers who released their findings at the American Academy of Dermatology Virtual Meeting Experience.

Courtesy Mount Sinai Health System

The drug, called etrasimod, did not meet the primary endpoint for improvement in the Eczema Area and Severity Index. However, nearly a third (29.8%) of those treated with a 2-mg dose daily reached “clear” or “almost clear” skin at 12 weeks vs. 13% for placebo as measured with clinician-reported Validated Investigator Global Assessment (vIGA) scores of 0 or 1 (P = .0450), study presenter Emma Guttman-Yassky, MD, PhD, professor and chair, department of dermatology, Icahn School of Medicine at Mount Sinai, New York, noted in an interview.

“This was a short proof-of-concept study to show this mechanism is valid. The results are promising,” Dr. Guttman-Yassky said. “They tell us that this can be a valid treatment for atopic dermatitis, a completely new mechanism of action that has potential in improving and even modifying the disease.”

Arena Pharmaceuticals, which developed the drug, hopes to launch a phase 3 study of the medication.

The ADVISE study enrolled 140 people in the United States, Australia, and Canada with chronic, moderate to severe eczema lasting for at least a year. (Their average age was 43, 61% were female, and 60% were White). They were randomly assigned to cohorts who took 1 mg or 2 mg daily of etrasimod or placebo for 12 weeks.

Those in the 2-mg cohort saw their scores on the peak pruritus numeric rating scale (PP-NRS) fall by 15.3% at week 4, compared with 1% for placebo (P = .0380); at week 12, the scores fell by 34.1% among those on 2 mg vs. 23.9% for placebo (P = .15 49). At 12 weeks, patients on the 2-mg dose also had more improvement in the Dermatology Life Quality Index or DLQI (a 7.6-point decline in degree of impairment vs. 4.2 points for placebo, P = .0122) and in the Patient-Oriented Eczema Measure or POEM (8.4-point reduction versus 4 points for placebo, P = .0045).

“Basically, there was a dose response. It doesn’t show a plateau,” Dr. Guttman-Yassky said. “ I think the data will be even better in a longer study.”

In regards to adverse events, participants who took etrasimod reported nausea, constipation, back pain, and dizziness at levels above 5% and above the levels for the placebo.

The drug appears to work by preventing immune cells from entering the skin, Dr. Guttman-Yassky said, and may be able to treat existing lesions and prevent new ones from appearing. Etrasimod is also being explored as a treatment for ulcerative colitis, alopecia areata, and multiple sclerosis, she said.

Dr. Guttman-Yassky noted that 12 weeks is a short time in AD, and she said some participants left the study because it took place during the coronavirus pandemic.

“There’s a huge unmet need in atopic dermatitis,” she said. “We need more drugs and different classes of drugs to treat the disease in all patients.” While biologics are often helpful, she said, they don’t work in many cases. And “some patients just don’t want a biologic, no matter how much we tell them it’s safe, and they may want an oral medication,” she said.

Dr. Guttman-Yassky is a paid consultant and researcher for Arena.

A novel, highly selective oral sphingosine 1-phosphate (S1P)–receptor modulator showed promise as a treatment for atopic dermatitis (AD) in a 12-week phase 2b trial, according to researchers who released their findings at the American Academy of Dermatology Virtual Meeting Experience.

Courtesy Mount Sinai Health System

The drug, called etrasimod, did not meet the primary endpoint for improvement in the Eczema Area and Severity Index. However, nearly a third (29.8%) of those treated with a 2-mg dose daily reached “clear” or “almost clear” skin at 12 weeks vs. 13% for placebo as measured with clinician-reported Validated Investigator Global Assessment (vIGA) scores of 0 or 1 (P = .0450), study presenter Emma Guttman-Yassky, MD, PhD, professor and chair, department of dermatology, Icahn School of Medicine at Mount Sinai, New York, noted in an interview.

“This was a short proof-of-concept study to show this mechanism is valid. The results are promising,” Dr. Guttman-Yassky said. “They tell us that this can be a valid treatment for atopic dermatitis, a completely new mechanism of action that has potential in improving and even modifying the disease.”

Arena Pharmaceuticals, which developed the drug, hopes to launch a phase 3 study of the medication.

The ADVISE study enrolled 140 people in the United States, Australia, and Canada with chronic, moderate to severe eczema lasting for at least a year. (Their average age was 43, 61% were female, and 60% were White). They were randomly assigned to cohorts who took 1 mg or 2 mg daily of etrasimod or placebo for 12 weeks.

Those in the 2-mg cohort saw their scores on the peak pruritus numeric rating scale (PP-NRS) fall by 15.3% at week 4, compared with 1% for placebo (P = .0380); at week 12, the scores fell by 34.1% among those on 2 mg vs. 23.9% for placebo (P = .15 49). At 12 weeks, patients on the 2-mg dose also had more improvement in the Dermatology Life Quality Index or DLQI (a 7.6-point decline in degree of impairment vs. 4.2 points for placebo, P = .0122) and in the Patient-Oriented Eczema Measure or POEM (8.4-point reduction versus 4 points for placebo, P = .0045).

“Basically, there was a dose response. It doesn’t show a plateau,” Dr. Guttman-Yassky said. “ I think the data will be even better in a longer study.”

In regards to adverse events, participants who took etrasimod reported nausea, constipation, back pain, and dizziness at levels above 5% and above the levels for the placebo.

The drug appears to work by preventing immune cells from entering the skin, Dr. Guttman-Yassky said, and may be able to treat existing lesions and prevent new ones from appearing. Etrasimod is also being explored as a treatment for ulcerative colitis, alopecia areata, and multiple sclerosis, she said.

Dr. Guttman-Yassky noted that 12 weeks is a short time in AD, and she said some participants left the study because it took place during the coronavirus pandemic.

“There’s a huge unmet need in atopic dermatitis,” she said. “We need more drugs and different classes of drugs to treat the disease in all patients.” While biologics are often helpful, she said, they don’t work in many cases. And “some patients just don’t want a biologic, no matter how much we tell them it’s safe, and they may want an oral medication,” she said.

Dr. Guttman-Yassky is a paid consultant and researcher for Arena.

Bimekizumab bested adalimumab for moderate to severe plaque psoriasis in a phase 3 trial of adults from the agent’s maker UCB Pharma.

The interleukin-17A and 17F blocker has also racked up significant wins against ustekinumab and secukinumab, other standard biologic options for adults with moderate to severe plaque psoriasis, and is currently under review for the indication by the U.S. Food and Drug Administration and European Medicines Agency.

In the adalimumab trial, dubbed BE SURE, bimekizumab had higher clinical response rates than the tumor necrosis factor (TNF) blocker over the 24-week head-to-head phase of the 478-patient trial, with substantial improvements in both Psoriasis Area and Severity Index (PASI) 90 response and Investigator’s Global Assessment (IGA) scores of 0 or 1, which signifies clear or almost clear skin.

The results were published in the New England Journal of Medicine and scheduled to be presented at the American Academy of Dermatology Virtual Meeting Experience on April 24.

“The data look good,” said psoriasis specialist Steven Feldman, MD, PhD, professor of dermatology at Wake Forest School of Medicine in Winston-Salem, N.C., when asked for comment.

Bimekizumab “appears more effective than current options. The big question is safety. The 10%-20% rate of oral candidiasis is much higher than other treatments but should be entirely manageable, as long as there are no unknown worse candida issues.” In addition, that there were no cases of inflammatory bowel disease in BE SURE “is very encouraging, as that is one of the limitations for existing IL-17 blockers,” he said.

The trial was launched after previous reports suggested that IL-17A inhibition may be better than TNF blockade in controlling psoriasis, said investigators led by Richard Warren, MBChB, PhD, a dermatology professor at the University of Manchester (England).

Patients were assigned evenly to one of three regimens: subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks; bimekizumab at 320 mg every 4 weeks for 16 weeks, then every 8 weeks out to 56 weeks; or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56.

At week 16, 86.2% of those in the bimekizumab group but just 47.2% in the adalimumab group had a PASI 90 response (P < .001), and 85.3% of the bimekizumab versus 57.2% in the adalimumab group had an IGA score of 0 or 1 (P < .001).

About 52% of the adalimumab group had a PASI 90 response at week 24, when they were switched to bimekizumab. By week 56, their PASI 90 response rate rose to 81.8%. Skin clearance was maintained through week 56 whether subjects were dosed every 4 or every 8 weeks with the interleukin blocker.

The incidence of oral candidiasis (9.5%-17.4% vs. 0% with adalimumab alone) was similar to other trials and likely because of the short circuiting of interleukin-17, which plays a role protecting against candida. Most cases were mild to moderate.

The increased risk of oral thrush with bimekizumab “may not be particularly clinically meaningful, especially if” it can be managed by an occasional fluconazole pill. It’s “reassuring … if that’s the biggest problem with the drug, or we may wonder if, in real life use, more severe, perhaps esophageal or systemic fungal infection may be observed,” Dr. Feldman said in a recent editorial.

“Not knowing the future may make some physicians reticent about using the drug when other options are available, at least until data are available on much larger numbers of exposed patients treated for longer periods of time,” he and his colleague William Huang, MD, also a dermatologist at Wake Forest, said.

One of the limits of the trial was that the head-to-head portion was only 24 weeks, “which was too brief for a comparison of safety between bimekizumab and adalimumab in a lifelong disease,” the investigators noted.

The mean age of the patients was 44.9 years, and the mean baseline PASI score was 19.8.

Although the initial dose of adalimumab in the study was 40 mg, labeling recommends an initial dose of 80 mg for the TNF blocker.

Bimekizumab is also being evaluated in phase 3 trials for psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa, according to UCB Pharma.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Dr. Warren who reported grants and personal fees from the company. Dr. Feldman reported receiving research, speaking, and/or consulting support from UCB Pharma and other companies.

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

Bimekizumab bested adalimumab for moderate to severe plaque psoriasis in a phase 3 trial of adults from the agent’s maker UCB Pharma.

The interleukin-17A and 17F blocker has also racked up significant wins against ustekinumab and secukinumab, other standard biologic options for adults with moderate to severe plaque psoriasis, and is currently under review for the indication by the U.S. Food and Drug Administration and European Medicines Agency.

In the adalimumab trial, dubbed BE SURE, bimekizumab had higher clinical response rates than the tumor necrosis factor (TNF) blocker over the 24-week head-to-head phase of the 478-patient trial, with substantial improvements in both Psoriasis Area and Severity Index (PASI) 90 response and Investigator’s Global Assessment (IGA) scores of 0 or 1, which signifies clear or almost clear skin.

The results were published in the New England Journal of Medicine and scheduled to be presented at the American Academy of Dermatology Virtual Meeting Experience on April 24.

“The data look good,” said psoriasis specialist Steven Feldman, MD, PhD, professor of dermatology at Wake Forest School of Medicine in Winston-Salem, N.C., when asked for comment.

Bimekizumab “appears more effective than current options. The big question is safety. The 10%-20% rate of oral candidiasis is much higher than other treatments but should be entirely manageable, as long as there are no unknown worse candida issues.” In addition, that there were no cases of inflammatory bowel disease in BE SURE “is very encouraging, as that is one of the limitations for existing IL-17 blockers,” he said.

The trial was launched after previous reports suggested that IL-17A inhibition may be better than TNF blockade in controlling psoriasis, said investigators led by Richard Warren, MBChB, PhD, a dermatology professor at the University of Manchester (England).

Patients were assigned evenly to one of three regimens: subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks; bimekizumab at 320 mg every 4 weeks for 16 weeks, then every 8 weeks out to 56 weeks; or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56.

At week 16, 86.2% of those in the bimekizumab group but just 47.2% in the adalimumab group had a PASI 90 response (P < .001), and 85.3% of the bimekizumab versus 57.2% in the adalimumab group had an IGA score of 0 or 1 (P < .001).

About 52% of the adalimumab group had a PASI 90 response at week 24, when they were switched to bimekizumab. By week 56, their PASI 90 response rate rose to 81.8%. Skin clearance was maintained through week 56 whether subjects were dosed every 4 or every 8 weeks with the interleukin blocker.

The incidence of oral candidiasis (9.5%-17.4% vs. 0% with adalimumab alone) was similar to other trials and likely because of the short circuiting of interleukin-17, which plays a role protecting against candida. Most cases were mild to moderate.

The increased risk of oral thrush with bimekizumab “may not be particularly clinically meaningful, especially if” it can be managed by an occasional fluconazole pill. It’s “reassuring … if that’s the biggest problem with the drug, or we may wonder if, in real life use, more severe, perhaps esophageal or systemic fungal infection may be observed,” Dr. Feldman said in a recent editorial.

“Not knowing the future may make some physicians reticent about using the drug when other options are available, at least until data are available on much larger numbers of exposed patients treated for longer periods of time,” he and his colleague William Huang, MD, also a dermatologist at Wake Forest, said.

One of the limits of the trial was that the head-to-head portion was only 24 weeks, “which was too brief for a comparison of safety between bimekizumab and adalimumab in a lifelong disease,” the investigators noted.

The mean age of the patients was 44.9 years, and the mean baseline PASI score was 19.8.

Although the initial dose of adalimumab in the study was 40 mg, labeling recommends an initial dose of 80 mg for the TNF blocker.

Bimekizumab is also being evaluated in phase 3 trials for psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa, according to UCB Pharma.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Dr. Warren who reported grants and personal fees from the company. Dr. Feldman reported receiving research, speaking, and/or consulting support from UCB Pharma and other companies.

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

Bimekizumab bested adalimumab for moderate to severe plaque psoriasis in a phase 3 trial of adults from the agent’s maker UCB Pharma.

The interleukin-17A and 17F blocker has also racked up significant wins against ustekinumab and secukinumab, other standard biologic options for adults with moderate to severe plaque psoriasis, and is currently under review for the indication by the U.S. Food and Drug Administration and European Medicines Agency.

In the adalimumab trial, dubbed BE SURE, bimekizumab had higher clinical response rates than the tumor necrosis factor (TNF) blocker over the 24-week head-to-head phase of the 478-patient trial, with substantial improvements in both Psoriasis Area and Severity Index (PASI) 90 response and Investigator’s Global Assessment (IGA) scores of 0 or 1, which signifies clear or almost clear skin.

The results were published in the New England Journal of Medicine and scheduled to be presented at the American Academy of Dermatology Virtual Meeting Experience on April 24.

“The data look good,” said psoriasis specialist Steven Feldman, MD, PhD, professor of dermatology at Wake Forest School of Medicine in Winston-Salem, N.C., when asked for comment.

Bimekizumab “appears more effective than current options. The big question is safety. The 10%-20% rate of oral candidiasis is much higher than other treatments but should be entirely manageable, as long as there are no unknown worse candida issues.” In addition, that there were no cases of inflammatory bowel disease in BE SURE “is very encouraging, as that is one of the limitations for existing IL-17 blockers,” he said.

The trial was launched after previous reports suggested that IL-17A inhibition may be better than TNF blockade in controlling psoriasis, said investigators led by Richard Warren, MBChB, PhD, a dermatology professor at the University of Manchester (England).

Patients were assigned evenly to one of three regimens: subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks; bimekizumab at 320 mg every 4 weeks for 16 weeks, then every 8 weeks out to 56 weeks; or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56.

At week 16, 86.2% of those in the bimekizumab group but just 47.2% in the adalimumab group had a PASI 90 response (P < .001), and 85.3% of the bimekizumab versus 57.2% in the adalimumab group had an IGA score of 0 or 1 (P < .001).

About 52% of the adalimumab group had a PASI 90 response at week 24, when they were switched to bimekizumab. By week 56, their PASI 90 response rate rose to 81.8%. Skin clearance was maintained through week 56 whether subjects were dosed every 4 or every 8 weeks with the interleukin blocker.

The incidence of oral candidiasis (9.5%-17.4% vs. 0% with adalimumab alone) was similar to other trials and likely because of the short circuiting of interleukin-17, which plays a role protecting against candida. Most cases were mild to moderate.

The increased risk of oral thrush with bimekizumab “may not be particularly clinically meaningful, especially if” it can be managed by an occasional fluconazole pill. It’s “reassuring … if that’s the biggest problem with the drug, or we may wonder if, in real life use, more severe, perhaps esophageal or systemic fungal infection may be observed,” Dr. Feldman said in a recent editorial.

“Not knowing the future may make some physicians reticent about using the drug when other options are available, at least until data are available on much larger numbers of exposed patients treated for longer periods of time,” he and his colleague William Huang, MD, also a dermatologist at Wake Forest, said.

One of the limits of the trial was that the head-to-head portion was only 24 weeks, “which was too brief for a comparison of safety between bimekizumab and adalimumab in a lifelong disease,” the investigators noted.

The mean age of the patients was 44.9 years, and the mean baseline PASI score was 19.8.

Although the initial dose of adalimumab in the study was 40 mg, labeling recommends an initial dose of 80 mg for the TNF blocker.

Bimekizumab is also being evaluated in phase 3 trials for psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, and hidradenitis suppurativa, according to UCB Pharma.

The study was funded by UCB Pharma. The investigators had numerous disclosures, including Dr. Warren who reported grants and personal fees from the company. Dr. Feldman reported receiving research, speaking, and/or consulting support from UCB Pharma and other companies.

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

Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

“The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

“The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

“The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

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