Brepocitinib (Lisraya) for Dermatomyositis: 6 Things to Know About the First Oral Option

You have a patient with dermatomyositis who has been on prednisone for 3 years. Every time you or another one of her prescribers tries to reduce her daily prednisone intake, her rash and weakness return. She’s on mycophenolate. She’s had IVIG. She is also beginning to develop cataracts and osteopenia from the steroids. This patient is why Lisraya exists.

The FDA approved Lisraya in August 2026 for dermatomyositis in adults. It’s a breakthrough medication, since dermatomyositis treatment has barely changed in decades. Here are six things to know.

1. What is Lisraya?

Lisraya is an oral medication that blocks two enzymes, TYK2 and JAK1. Those enzymes carry the signals from several cytokines that drive dermatomyositis. Blocking them turns that signaling down.

Lisraya is the first medication that was specifically designed from the ground up to treat dermatomyositis. All other medications for dermatomyositis were developed for another condition, and then later found to be useful (like IVIG), or they’re simply used off-label (like prednisone, methotrexate, mycophenolate, azathioprine, and hydroxychloroquine).

This is a big deal because prior attempts to add a drug targeted specifically for dermatomyositis have mostly failed. The pivotal rituximab trial for myositis found no significant difference in the treatment arm versus the control group. And abatacept, tocilizumab, and ustekinumab all missed their primary endpoints too.

2. What the data show

The phase 3 trial that studied Lisraya was dubbed VALOR, and it randomized 241 adults with dermatomyositis to Lisraya 30 mg or placebo for 52 weeks. Everyone stayed on their background therapy, and steroids were tapered on a set schedule.

At 1 year, 69% of patients on the 30 mg dose hit a Total Improvement Score (TIS) of at least 40. TIS is a composite score that pulls together muscle strength, physical function, muscle enzymes, and physician and patient assessments — and a score of 40 indicates moderate improvement. On placebo, 47% of patients hit a TIS of 40.

It’s notable that nearly half of the placebo group improved, too; likely because these patients were still taking their other medications. So what Lisraya really provides is that extra improvement on top of usual care.

3. Steroid sparing is a big takeaway

In dermatomyositis, the cumulative cost of prednisone over years often rivals the disease. The VALOR study built a taper into the protocol and then measured whether it held at week 52.

Among patients taking at least 7.5 mg of prednisone a day at baseline:

• 62% were down to 2.5 mg or less compared with 38% on placebo. 

• 45% were off steroids completely, versus 29% in the placebo group.

So on top of overall improvements in TIS scores, the reduction in steroid use is one of the biggest take home points.

4. The boxed warning

Lisraya carries the JAK-class boxed warning: serious infections, death from any cause, cancer, major cardiovascular events, and blood clots.

But two things about that warning stand out:

• First, most of it isn’t specific to Lisraya. It’s borrowed from a large safety study of a different JAK inhibitor in rheumatoid arthritis. In the VALOR study itself, cancers, cardiac events, and clots were actually more common in the placebo group.

• Second, the thing that did show up in VALOR was infection. Serious infections occurred in 10% of treated patients versus 1% on placebo, most often pneumonia and sepsis. Shingles reactivation occurred in 5%.

5. The pretreatment workup

Considering the safety data, there are several things you need to do before the first dose:

• Tuberculosis: Test for latent and active TB, and treat first if positive.

• Hepatitis: Screen for hepatitis B and C. Lisraya is not recommended with active infection.

• CBC: Check this first, and don’t start Lisraya if the lymphocyte count is under 500, the neutrophil count is under 1,000, or hemoglobin is under 8 g/dL.

• Liver and kidney function: Check both, and don’t start if there is severe impairment of either.

• Pregnancy: Test for pregnancy. Lisraya caused fetal harm in animals, so patients need effective contraception during treatment and for 3 days after the last dose.

• Vaccines: Update them first, including shingles. Counsel patients to avoid live vaccines during treatment.

• Smoking: Counsel on cessation. Smoking induces enzymes that clear Lisraya and cut its blood levels by almost half.

6. Cost and access

The list price is about $35,000 a month. Dermatomyositis is chronic, so that’s a large open-ended commitment for your patient. Expect prior authorization in every case.

It’s also distributed through a limited specialty pharmacy network, so this isn’t a script you send to the patient’s usual drugstore.

The manufacturer runs a support program that helps with coverage and can bring the copay to $0 for eligible patients with commercial insurance. Patients on Medicare or Medicaid can’t use manufacturer copay assistance though, since federal anti-kickback rules exclude them.

Why trust our experts?

Written by:

Farzon A. Nahvi, MD

Farzon Nahvi, MD, is an emergency medicine physician and author of “Code Gray: Death, Life, and Uncertainty in the ER.” He works at Concord Hospital in Concord, New Hampshire, and teaches at the Geisel School of Medicine at Dartmouth.

Edited by:

Mandy Armitage, MD

Mandy Armitage, MD, has combined clinical medicine with her passion for education and content development for many years. She is co-executive director at Nonclinical Physicians Network and has served as medical director for the health technology companies HealthLoop (now Get Well) and Doximity.

Reviewed by:

Maria Robinson, MD, MBA

Maria Robinson, MD, MBA, is a board-certified dermatologist and dermatopathologist who has practiced dermatology and dermatopathology for over 10 years across private practice, academic, and telehealth settings. She is a fellow of the American Academy of Dermatology and the American Society of Dermatopathology.

Our editorial standards

Meet our experts