If you're living with dermatomyositis, there is a newer treatment option available. Lisraya (brepocitinib) is a prescription medicine approved by the FDA to treat dermatomyositis in adults. It works on the immune system to help calm the inflammation that leads to muscle weakness and skin changes in people with this condition.
Dermatomyositis is a rare autoimmune disease. It happens when your immune system mistakenly attacks your muscles and skin, which causes inflammation. This can lead to muscle weakness along with a distinctive skin rash.
Common symptoms of dermatomyositis may include:
- Muscle weakness, often in the hips, thighs, shoulders, upper arms, and neck
- A reddish or purplish rash, often on the eyelids, face, chest, knuckles, elbows, or knees
- Trouble climbing stairs, standing up from a chair, lifting objects, or raising your arms
- Tiredness
- Trouble swallowing
- Muscle pain or tenderness
Keep reading to learn how Lisraya works for dermatomyositis, how it's taken, what the research shows, and what to know before you start.
How Does Lisraya Work for Dermatomyositis?
In dermatomyositis, the immune system sends too many inflammatory signals, which are carried by proteins called cytokines. They tell the body to create inflammation that damages muscle and skin. One group of cytokines, called type I interferons, is thought to play a large role in dermatomyositis.
Lisraya contains the active ingredient brepocitinib. It belongs to a group of medicines known as Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitors. JAK and TYK2 are enzymes inside your cells that help pass along these inflammatory signals.
Brepocitinib blocks JAK1 and TYK2, interrupting the signals from several cytokines, including type I interferons and interleukin-6 (IL-6). In studies of people with dermatomyositis, this led to lower activity of genes tied to type I interferon signaling. This reduces inflammation that drives muscle weakness and skin symptoms.
Lisraya helps manage dermatomyositis, but it is not a cure.
Is Lisraya Right for Me?
Lisraya is FDA-approved to treat dermatomyositis in adults. It has not been studied in children with juvenile dermatomyositis, so it is not approved for that group.
Lisraya is not meant to be combined with certain vaccines or other strong immune-focused medicines. It is not recommended for use with:
- Other JAK inhibitors, such as abrocitinib or ruxolitinib
- Other TYK2 inhibitors, such as deucravacitinib
- Biologic disease-modifying antirheumatic drugs (DMARDs), such as adalimumab or etanercept
Because Lisraya affects the immune system, your health care provider will review your health history before you start. Tell them if you have any current or past infections, have ever had cancer, or have heart problems, liver or kidney problems, or diabetes. Also let them know if you are pregnant or planning to become pregnant. Your health care provider can help decide whether Lisraya is right for you.
How Was Lisraya Studied for Dermatomyositis?
The FDA approved Lisraya based on a clinical trial called Trial DM. This was a large, carefully designed study. People were randomly placed into treatment groups; neither they nor the researchers knew who was getting Lisraya and who was getting a placebo (a pill with no medicine).
The study included 241 adults with dermatomyositis. Here are some details about who took part:
- Most (78%) were women, and the rest were men.
- Most (72%) were White, 10% were Asian, and about 7% were Black. About 24% identified as Hispanic or Latino ethnicity.
- The average age was 51 years.
- About 2 in 3 (65%) had at least one heart disease risk factor.
- About 1 in 5 (20%) had a lung condition called interstitial lung disease.
- Most were already using other dermatomyositis treatments, such as oral corticosteroids (76%) and other immune-suppressing medicines (72%). They were allowed to keep taking these at a steady dose during the study.
Participants were randomly assigned to take Lisraya 30 mg once daily or a placebo (a pill with no medicine) once daily for 52 weeks.
The main goal was to measure improvement using the Total Improvement Score (TIS) at week 52. The TIS is a combined score that looks at six measures of dermatomyositis, including muscle strength, physical function, skin and muscle disease activity, and muscle-related lab tests. Scores range from 0 to 100, and a higher score means more improvement.
What Benefits of Lisraya Were Seen in Studies?
After 52 weeks, people taking Lisraya showed more improvement in their dermatomyositis than those taking placebo. On average, the Lisraya group reached a higher TIS, and more people reached meaningful levels of improvement.
The table below summarizes the main results at week 52.
| Result at Week 52 | Placebo (79 people) | Lisraya 30 mg (81 people) |
|---|---|---|
| Average Total Improvement Score (greater score = more improvement) | 33.3 | 47.5 |
| Reached minimal improvement (score ≥ 20) | 63% | 82% |
| Reached moderate improvement (score ≥ 40) | 47% | 69% |
| Reached major improvement (score ≥ 60) | 26% | 48% |
In other words, about 48% of people taking Lisraya reached major improvement, compared with about 26% of those taking placebo.
People taking Lisraya also improved on individual measures, including muscle strength, physical function, skin disease (mainly less redness), and muscle-related lab tests.
Lisraya may also help some people lower their steroid dose. Among participants who were taking higher steroid doses at the start, more of those on Lisraya were able to reduce or stop steroids by the end of the study than those on placebo.
Keep in mind that your results may differ from what was seen in the study.
How Do I Take Lisraya?
Lisraya comes as a 30-mg tablet. The usual dose is one tablet (30 mg) by mouth once a day. You can take it with or without food.
Take Lisraya exactly as your health care provider tells you, and try to take it around the same time each day. If you miss a dose, ask your provider or pharmacist how to get back on track, and do not take two doses at once to make up for a missed one.
Before you start Lisraya, your provider will likely order some tests, which may include:
- A test for tuberculosis (TB)
- Blood tests to check your blood cell counts, liver, and kidney function
- Screening for hepatitis B and C
- A pregnancy test, if you can become pregnant
Your provider will also make sure your vaccines are up to date before you begin, since you should not receive certain vaccines while taking Lisraya.
You will need regular blood tests during treatment to check your blood counts, cholesterol, and liver function tests. Do not stop taking Lisraya without talking to your provider first.
How Long Does It Take for Lisraya to Work?
Lisraya does not work overnight. In the study, improvement was seen as early as a few weeks after starting. Improvement continued to build over the following months, with people still improving at the one-year mark.
Because dermatomyositis affects people differently, it may take time to notice changes in your muscle strength, energy, skin, or daily activities. Keep taking Lisraya as prescribed, even if you don't feel a difference right away, and talk to your provider about what to expect.
One thing to know: Smoking may make Lisraya less effective because it changes how your body breaks down the medicine. If you smoke, talk to your provider about support to help you quit.
What Else Should I Know About Lisraya?
Lisraya has a boxed warning, which is the FDA's strongest warning. It covers the risk of serious infections, blood clots, heart-related events, and certain cancers. It's important to understand these risks and how to lower them. You can learn more in our companion article on Lisraya side effects and interactions.
A few other things to keep in mind:
- Pregnancy: Lisraya may harm a fetus. If you can become pregnant, use effective birth control during treatment and for three days after your last dose. Tell your provider right away if you become pregnant.
- Breastfeeding: Do not breastfeed during treatment and for three days after your last dose.
- Sun protection: Lisraya may raise the risk of skin cancer, so make sure to limit your time in the sun, avoid tanning beds, and use sunscreen and protective clothing.
How Do I Get Lisraya, and What Kind of Doctor Prescribes It?
Lisraya is available only with a prescription. Because dermatomyositis is a complex condition, it is usually managed by a specialist, such as a rheumatologist (a doctor who treats muscle, joint, and autoimmune conditions) or a dermatologist (a skin specialist). These providers can confirm your diagnosis, order the tests needed before you start, and monitor you during treatment.
Is There Any Cost Assistance Available for Lisraya?
The cost of Lisraya can depend on your insurance coverage. The drugmaker offers a savings program that helps eligible patients lower their out-of-pocket costs. It also provides patient support, including help with insurance approval and coordination with the specialty pharmacy that will fill your prescription. You can visit the website or call 888-736-9788 to learn more.
