Q&A: Victoria Werth, MD, on Brepocitinib's FDA Approval for Dermatomyositis

The FDA recently approved brepocitinib (Lisraya; Priovant Therapeutics) as the first oral therapy indicated specifically for dermatomyositis, based on results from the phase 3 VALOR trial (NCT05437263).¹

A skin-specific secondary analysis of VALOR, published in JAMA Dermatology, showed brepocitinib 30 mg produced early, sustained improvement in Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) scores, itch, and skin-related quality of life through week 52.²

Victoria Werth, MD, professor of dermatology and rheumatology at the University of Pennsylvania and the Philadelphia VA Medical Center, spoke with Dermatology Times about what the approval means for patients, how quickly skin improvement appeared in the trial, what the response pattern across outcome measures suggests about the drug's effect, how it should reshape treatment goals for skin disease, how to discuss the boxed warning with patients, and her message to clinicians on standard of care.

Q&A With Victoria Werth, MD

Dermatology Times: What does the first FDA-approved oral therapy for dermatomyositis mean for patients who relied on off-label treatment?

Werth: This is revolutionary because up until now, we really didn't have anything on label for patients, and very often they would have to be on immunosuppressants for long periods of time, or get prednisone or infusions for long periods of time. Having an oral option will be important for patients, and one that's safe and effective is really going to be helpful.

Dermatology Times: Skin improvements appeared by week 4 in the VALOR trial. How does this compare with typical dermatomyositis response?

Werth: I think one thing to remember is that the patients had been on steroids, and steroids can improve things relatively quickly, but they have a huge amount of toxicity. The patients in this trial were not doing all that well, despite their background therapy, so the fact that these patients could start to show improvement as early as 4 weeks is dramatic, because often in a refractory type of situation, it can take much longer and even become difficult to get those kinds of patients under control.

Dermatology Times: You saw CDASI-A, itch, and quality-of-life scores all improve together. What does this pattern tell you about how brepocitinib works?

Werth: It's wonderful when outcome measures incorporate not just the objective disease activity, but also what's subjective for the patient, because actually it's the patient that's the most important. How do they feel about what's happening in terms of response to a treatment? And the reality is that each of these measures, whether it be CDASI-A or different ways of looking at itch or quality of life, altogether those things all improved in the same direction, and that's helpful in establishing whether a drug is effective or not.

Dermatology Times: With an approved, targeted option now available, what should change in how clinicians set treatment goals for skin disease?

Werth: For one, it's been difficult to get off-label drugs for dermatomyositis. It's been considered a bit of an orphan disease, and it really has been navigating really difficult issues with insurance companies to get off-label drugs approved. That delays treatment and often inhibits treatment completely. Now that this drug is approved, I think it will become much simpler to have options for patients. I think that should be a goal: patients will get treated early and also get under control as quickly as possible. Having an approved option is amazing compared to where we've been.

Dermatology Times: Brepocitinib carries a boxed warning shared with other JAK/TYK2 inhibitors. How should clinicians discuss this risk-benefit tradeoff with patients?

Werth: It's absolutely important to address those issues with patients, and they'll get to see the black box. However, what I would say is glucocorticoids should have 2 black boxes. They're toxic to patients and really horrible. And the established immunosuppressives that we use, whether it be methotrexate or mycophenolate, also have many side effects, some of the same side effects that we are concerned about with these drugs. So what's different is it's a new drug, and the incidence is actually not known this early on in an approval process. But relative to the other drugs that we have available, I think it would not be hard to have a conversation with patients about the black box.

Dermatology Times: What message would you share with clinicians about brepocitinib and improving the standard of care for dermatomyositis?

Werth: This is the first oral drug that can be used for dermatomyositis, again approved for the disease, and I think it means we will have many more options for patients who are not responding, for instance, to topicals or relatively low doses of other medications. It will provide options for patients who have both skin and muscle disease with dermatomyositis, and it's something that I think practitioners need to be aware of. For patients who are not doing well, practitioners should consider use early on in the disease course.

Dermatology Times: Any closing thoughts on brepocitinib or the data supporting its approval?

Werth: The most recent article that was just published in JAMA Dermatology highlights really the improvements that we've been seeing in all the different skin measures, itch, and quality of life, as we talked about. And I think that's really key for these patients who've been suffering with really not sufficient options for care. So this is a very exciting time.

Editor’s note: This Dermatology Times Q&A has been edited and consolidated from a recorded interview to improve readability while preserving the substance of the original conversation.

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 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults
2. Mangold AR, Haemel A, Shahriari N, et al. Skin-specific outcomes of brepocitinib in patients with dermatomyositis: secondary analysis of a phase 3 randomized clinical trial. JAMA Dermatol. 2026.. doi:10.1001/jamadermatol.2026.3199