Brepocitinib's Boxed Warning Compares To Existing Therapy Risks in Dermatomyositis

Victoria Werth, MD, professor of dermatology and rheumatology at the University of Pennsylvania and the Philadelphia VA Medical Center, recently discussed brepocitinib's (Lisraya; Priovant Therapeutics) boxed warning and expanded treatment options for dermatomyositis. Brepocitinib recently became the first oral drug specifically indicated for the condition, based on results from the phase 3 VALOR trial. Werth addressed how the drug's safety profile compares with existing dermatomyositis therapies and what the approval means for patient care.¹

The VALOR trial (NCT05437263) enrolled 241 adults across 90 sites, comparing brepocitinib 30 mg and 15 mg once daily against placebo over 52 weeks. Brepocitinib 30 mg produced a mean Total Improvement Score of 46.5 at week 52, versus 31.2 with placebo.¹

Comparing Boxed Warning Risk To Existing Therapies

"Glucocorticoids should have two black boxes. They're really toxic for patients and really horrible," Werth said. "The established immunosuppressives we use, whether methotrexate or mycophenolate, also have many side effects and some of the same side effects we're concerned about with these drugs," she added.

Werth said the incidence associated with a new drug is not fully known early in an approval process. Relative to other available therapies, she said conversations with patients about the boxed warning should not be difficult.

First Oral Option Expands Treatment Choices

"This is the first oral drug approved for dermatomyositis," Werth said. She said the approval means more options for patients not responding to topicals or relatively low doses of other medications.

More than two-thirds of patients receiving brepocitinib 30 mg achieved a moderate response, and 46% achieved a major response, compared with 44% and 26% among those on placebo, respectively.

Addressing Skin and Muscle Disease Together

"It's really going to provide options for patients who have both skin and muscle disease with dermatomyositis," Werth said. Practitioners need to be aware of the option, she said, particularly for patients not doing well who could benefit from earlier use in the disease course.

Recent Data Reinforce Patient Quality of Life Gains

Skin-specific improvement with brepocitinib 30 mg occurred early, with a CDASI-A difference of 3.0 points versus placebo by week 4, sustained through week 52. Among patients with moderate to severe skin disease at baseline, 44% achieved cutaneous remission by week 52, compared with 21% on placebo.

Werth pointed to a recent JAMA Dermatology article highlighting improvements across skin measures, itch, and quality of life.² "I think this is really key for these patients who've been suffering with insufficient options for care," Werth said. "This is a very exciting time," she added.

References

1. FDA approves first oral drug indicated to treat dermatomyositis in adults. News release. US Food and Drug Administration. August 27, 2026. Accessed September 8, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults
2. JAMA Dermatology publishes skin-specific outcomes from phase 3 VALOR trial of brepocitinib in dermatomyositis. News release. Roivant Sciences. August 26, 2026. Accessed September 9, 2026. https://www.globenewswire.com/news-release/2026/08/26/3351560/34323/en/jama-dermatology-publishes-skin-specific-outcomes-from-phase-3-valor-trial-of-brepocitinib-in-dermatomyositis.html