Proven to deliver relief for dermatomyositis

Explore how LISRAYA helped patients reduce their overall disease activity, improve their skin symptoms, increase their physical function, and decrease their steroid use.

LISRAYA was studied in VALOR, the largest clinical study ever conducted for adults with dermatomyositis

HCP Explainer Video | Rigorous Clinical Data

Study Duration
VALOR followed dermatomyositis (DM) patients for a full year (52 weeks). 
Study Participants
VALOR included 241 adults with DM.
Study Population
Patients in VALOR were representative of people with DM in the real world. 

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Hi, my name is Dr. Iazsmin Bauer Ventura.

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I am a board-certified adult rheumatologist at the University of Chicago Medicine,

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where I serve as the director of the myositis program and a member of the

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multidisciplinary interstitial lung disease team.

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I’m an expert in treating and diagnosing dermatomyositis.

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When I look at a new therapy, I want to make sure that the evidence from this

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clinical trial is relevant to a patient.

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LISRAYA was studied in a clinical trial called the VALOR study, a year-long

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placebo-controlled trial that was the largest ever conducted in dermatomyositis or

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DM. That’s a big deal because dermatomyositis is a complex disease in which many

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investigational therapies have unfortunately failed over the years.

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One important thing I want to highlight about the VALOR study is that it focused

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specifically on dermatomyositis, and the patients who participated look very much

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like the ones I care for in my own practice.

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They experienced a wide range of symptoms, including muscle weakness, rash, itch.

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Most had already tried multiple medications for dermatomyositis, and many have

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continued to experience day-to-day challenges of living with this disease.

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Importantly, the study also included patients with many of the other health

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conditions we commonly see alongside dermatomyositis, including interstitial lung

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disease, high blood pressure, obesity, diabetes, even prior histories of cancer.

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In other words, LISRAYA was studied in patients very similar to the ones I care for

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every day, and the results were clinically significant.

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Patients taking LISRAYA experienced meaningful improvements across multiple aspects

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of their dermatomyositis, including muscle symptoms, rash, and the ability to

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perform activities central to their daily life like grooming, bathing, and doing

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household chores. Many patients were also able to reduce their reliance on oral

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steroids over time. As a physician, the strength of the VALOR study gives me

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confidence when recommending LISRAYA to my patients.

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LISRAYA can lower your ability to fight infections.

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Before treatment, test for TB and do blood work.

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Serious infections, cancers, heart attack, stroke, blood clots, and death have

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occurred. Tell your doctor if you’ve had these events, infection, Hep B or C,

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smoked, are pregnant or planning. Don’t take if allergic or have an infection.

LISRAYA drove significant overall improvement

To get a complete picture of how VALOR study patients were doing, doctors measured their progress using Total Improvement Score (TIS). Think of TIS as a “report card” for DM: it combines various measures of different symptoms into a single score. A higher TIS means greater overall improvement.

Patients taking LISRAYA showed significantly more improvement on TIS than patients taking placebo (mean TIS of 47.5 vs 33.3).

These improvements were seen as early as 4 weeks after starting treatment with LISRAYA.

69

%

moderate or major improvement

Over two-thirds of LISRAYA patients showed a moderate or major improvement in their overall DM symptoms after one year (based on TIS), compared to 47% taking placebo.

When asked to rate their overall disease activity in a Patient Global Assessment (PtGA) score, patients receiving LISRAYA reported more than four times as much improvement as patients on placebo.

LISRAYA helped DM patients regain strength for daily life

HCP Explainer Video | Improvement in Muscle & Function

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Hi, I’m Michelle Min, Director of Rheumatologic Dermatology and Director of Medical
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Dermatology at the University of California Irvine School of Medicine.
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I’ve been managing patients with dermatomyositis, or DM, for the past five years.
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One of the things that strikes me about dermatomyositis is how much it takes away
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from everyday life. Getting dressed in the morning, washing your hair, reaching for
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something on a shelf, climbing up a flight of stairs.
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These are activities most people never think twice about, but for someone living
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with DM, they can become difficult, exhausting, or sometimes impossible.
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That’s why the improvements in day-to-day functioning seen in the VALOR study of
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LISRAYA are so meaningful to me.
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Patients taking LISRAYA reported less pain and said it became easier to do the
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everyday activities I just described.
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The kinds of things that help people maintain their independence, feel like
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themselves again, and live a more normal life.
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Importantly, these improvements weren’t just observed by doctors in a clinical
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setting or in laboratory tests. Patients reported meaningful changes in their
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day-to-day lives, like being able to get dressed on their own or bathe themselves
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without needing help. And for some patients, the benefits went even further.
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Many patients treated with LISRAYA improved so much that they reached what we call
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functional remission, meaning their dermatomyositis was no longer impacting
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everyday activities. That kind of change can have a profound impact on the lives of
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people living with dermatomyositis, because ultimately, treatment isn’t just about
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improving numbers on a chart. It’s about helping patients get back to living their
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lives.
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LISRAYA can lower your ability to fight infections.
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Before treatment, test for TB and do bloodwork.
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Serious infections, cancers, heart attack, stroke, blood clots, and death have
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occurred. Tell your doctor if you’ve had these events, infection, hep B or C,
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smoked, are pregnant, or planning. Don’t take if allergic or have an infection.

Patients taking LISRAYA reported that they experienced less pain and fatigue and that they found it easier to do common daily activities, such as:
  • Getting dressed
  • Eating
  • Washing their hair
  • Running errands
  • Reaching for objects
These improvements were measured using a questionnaire called HAQ-DI,1 in which patients rated their pain and how difficult it was for them to perform a range of common activities.
  • Over the course of the study, patients taking LISRAYA saw significant improvement in their HAQ-DI scores, while patients taking placebo got worse.
  • Over 40% of LISRAYA patients even improved so much that they achieved “functional remission”—a HAQ-DI score so low that they were functioning like they had no disease.2
1Health Assessment Questionnaire-Disability Index.
244% of LISRAYA patients achieved HAQ-DI functional remission (HAQ-DI <0.5) compared to 20% on placebo. This was a “post hoc analysis,” meaning that additional work would be needed to confirm the result.

LISRAYA improved skin symptoms

HCP Explainer Video | Improvement in Skin

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Hi, I’m Michelle Min, Director of Rheumatologic Dermatology and Director of Medical
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Dermatology at the University of California Irvine School of Medicine.
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I’ve been managing patients with dermatomyositis, or DM, for the past five years.
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For many of my patients with dermatomyositis, skin disease is one of the most
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visible, symptomatic, frustrating, and emotionally difficult parts of their
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condition. The rash, the redness, the hair loss, the itch, these symptoms not only
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affect physical comfort and sleep, but also confidence, social interactions, and
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overall quality of life. That’s why the skin results seen with LISRAYA in the VALOR
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trial are worth discussing. Let’s take a look at one patient as an example.
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Here, you’re looking at photographs of the elbow and outer thigh from a real
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patient enrolled in the VALOR study.
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On the left, at the start of treatment, notice the significant redness and
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ulceration, areas where the skin has broken down.
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These are classic manifestations of dermatomyositis skin disease, including what
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doctors refer to as Gottron’s sign on the elbow and Holster’s sign on the outer
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thighs. On the right, after treatment with LISRAYA , you see substantial
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improvement. The redness on the patient’s elbow and thigh has faded, inflammation
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is shut down, ulcerations have healed, and the skin appears much closer to normal.
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Here is that same patient’s face. At the start of the trial, notice the prominent
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redness and inflammation across the forehead and face, a very common and
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distressing manifestation of DM skin disease.
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By the end of treatment with LISRAYA, that redness and inflammation has improved
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substantially. While these images reflect a single patient’s experience, the skin
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benefits seen in the VALOR study extended to the majority of patients treated with
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LISRAYA. Importantly, these improvements happened quickly.
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Some patients began experiencing benefits as early as the first follow-up visit
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four weeks after starting LISRAYA, something that can be especially meaningful for
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patients who have been living with persistent symptoms for months or even years.
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And these gains did not fade over time.
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Patients continued to experience improvement in their skin symptoms throughout the
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full 52 weeks of the study. Even among patients who entered the trial with moderate
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to severe skin disease, patients who are often the most difficult to treat and the
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most likely to fail other therapies, many achieved clear or almost clear skin with
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LISRAYA. If you’d like to learn more about whether LISRAYA might be right for you,
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bring it up with your doctor. Ask about LISRAYA.
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LISRAYA can lower your ability to fight infections.
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Before treatment, test for TB and do blood work.
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Serious infections, cancers, heart attack, stroke, blood clots, and death have
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occurred. Tell your doctor if you’ve had these events, infection, hep B or C,
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smoked, are pregnant, or planning. Don’t take if allergic or have an infection.

In addition to getting stronger and improving their ability to do everyday activities, LISRAYA patients in the VALOR study saw significant improvement in their skin disease activity.3

Real patient photos

Before taking LISRAYA
Real patient photo showing a dermatomyositis rash on the forehead before taking LISRAYA
Real patient photo showing a violet-red dermatomyositis rash on the skin before taking LISRAYA
Real patient photo showing scattered dermatomyositis skin marks before taking LISRAYA
After one year
Real patient photo showing the same area of the forehead after one year of treatment with LISRAYA
Real patient photo showing the same area of skin after one year of treatment with LISRAYA
Real patient photo showing the same area of scattered skin marks after one year of treatment with LISRAYA
Many patients taking LISRAYA went from having significant skin disease activity
at baseline to having nearly none at all.4
3Patients taking LISRAYA saw improvement in CDASI-A, a score used by physicians to measure activity and damage of skin disease in DM, of 12.2 points compared to 8.0 with placebo.
4By the end of the VALOR study, 46% of patients who had moderate to severe skin disease (a score of 3+ on the CDA-IGA, a score used by physicians to measure skin disease) at the start of the study achieved clear or almost clear skin (a CDA-IGA score of 0 or 1) with LISRAYA, vs. 22% of patients taking placebo. This was a “post hoc analysis,” meaning that additional work would be needed to confirm the result.

LISRAYA helped DM patients
reduce their reliance on steroids

HCP Explainer Video | Reducing Steroid Use

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My name is Brooke Eastham, and I’m a board-certified dermatologist with more than a
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decade of experience in medical dermatology.
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I have a particular interest in autoimmune skin diseases with a special focus on
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dermatomyositis. I am dedicated to delivering the highest standard of patient care
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and to providing access to the most current evidence-based treatments and
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advancements in dermatologic medicine.
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If you’ve been living with dermatomyositis, there’s a good chance that steroids
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have been a part of your treatment.
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And while steroids can be an important tool for controlling inflammation and
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managing symptoms, they often come with a real physical and emotional cost over
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time. If you’ve taken steroids, then you know the challenges that they bring.
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That’s why one of the things I find most meaningful about LISRAYA is its potential
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to help patients reduce their reliance on steroids.
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In the VALOR study, more than 60% of patients taking LISRAYA who were on steroids at
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the start of the study were able to either stop their steroids completely or reduce
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to only a very low daily dose by the end of the trial.
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For many patients, that kind of steroid reduction can represent a major step
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forward in their dermatomyositis journey.
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Most patients taking LISRAYA were also able to improve their dermatomyositis
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symptoms at the same time that they were reducing their steroid use.
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That combination is incredibly important.
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For my patients who have struggled, the potential steroid-sparing benefits seen
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with LISRAYA could make a big difference.
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LISRAYA can lower your ability to fight infections.
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Before treatment, test for TB and do blood work.
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Serious infections, cancers, heart attack, stroke, blood clots, and death have
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occurred. Tell your doctor if you’ve had these events, infection, Hep B or C,
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smoked, are pregnant or planning. Don’t take if allergic or have an infection.

LISRAYA can help significantly reduce reliance on steroids while still improving disease activity.5

In the VALOR study, over 60% of LISRAYA patients who were taking moderate or higher doses of steroids were able to either completely stop taking steroids or reduce to a very low daily dose.6
5Among LISRAYA patients, 55% were able to achieve moderate or better improvement (TIS≥40) and minimal-to-no steroids (2.5 mg/ day or less) compared to 30% on placebo.
6Among patients taking greater than or equal to 7.5 mg/day of corticosteroids at baseline, 62% were able to achieve a corticosteroid dose of less than or equal to 2.5 mg/day at weeks 48-52, compared to 38% subjects treated with placebo.

Learn more about LISRAYA

Doctor talking with a patient about dermatomyositis treatment options

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Find tips to start a conversation with your doctor about LISRAYA. 
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Explore a personalized resource offered to help people taking LISRAYA navigate their treatment journey.
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Indication

LISRAYA (brepocitinib) is used for the treatment of adults with dermatomyositis (DM).

Limitations of Use
LISRAYA should not be used in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

Important Safety Information

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

USE
LISRAYA (brepocitinib) is used for the treatment of adults with dermatomyositis (DM).

Limitations of Use
LISRAYA should not be used in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

LISRAYA can cause serious side effects, including:
Serious infections. LISRAYA can lower your ability to fight infections. Serious infections have happened while taking LISRAYA, including active tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting LISRAYA and check you closely for signs and symptoms of TB during treatment with LISRAYA. You should not start taking LISRAYA if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).

Increased risk of death in people 50 years of age and older who have at least 1 heart disease risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. LISRAYA is a JAK inhibitor medicine.

Cancer and immune system problems. LISRAYA may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP’s advice about having your skin checked for skin cancer during treatment with LISRAYA. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.

Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a JAK inhibitor, especially if you are a current or past smoker.

Blood clots. Blood clots in the veins of your legs or lungs and arteries can happen in some people taking LISRAYA. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor taking a JAK inhibitor.

Allergic Reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat that may mean you are having an allergic reaction have been seen in people taking LISRAYA. Some of these reactions were serious. If any of these symptoms occur during treatment with LISRAYA, stop taking LISRAYA and get emergency medical help right away.

Tears in the stomach or intestines. Some people taking LISRAYA can get tears in their stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.

Low blood sugar in people with diabetes. If you have diabetes, your healthcare provider may tell you to check your blood sugar (glucose) more often during treatment with LISRAYA. Call your healthcare provider if you have any problems with low blood sugar.

Changes in certain laboratory tests. Your HCP should do blood tests before you start taking LISRAYA and while you take it. Your HCP may stop your LISRAYA treatment for a period of time if needed because of changes in these blood test results.

Before taking LISRAYA, tell your HCP if you:

  • have an infection.
  • are a current or past smoker.
  • have had any type of cancer.
  • have had a heart attack or other heart problems, or stroke.
  • have liver or kidney problems.
  • have unexplained stomach (abdominal) pain, have a history of diverticulitis or ulcers in your stomach or intestines, or are taking NSAIDs.
  • have diabetes.
  • have low red or white blood cell counts.
  • have recently received or are scheduled to receive an immunization (vaccine). People taking LISRAYA should not receive live vaccines.
  • are pregnant or plan to become pregnant. LISRAYA may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. LISRAYA may pass into your breast milk. Do not breastfeed during treatment with LISRAYA and for 3 days after your last dose of LISRAYA. 

Females who are able to become pregnant:

  • Your healthcare provider will check whether or not you are pregnant before you start treatment with LISRAYA.
  • You should use effective birth control (contraception) to avoid becoming pregnant during treatment with LISRAYA and for 3 days after your last dose of LISRAYA.
  • Tell your healthcare provider if you think you are pregnant or become pregnant during treatment with LISRAYA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LISRAYA and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take medicines that affect your immune system as these medicines may increase your risk of infection. Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines.

The most common side effects of LISRAYA include:

  • common cold, sinus infections, or sore throat (upper respiratory tract infections)
  • headache
  • tired or lack of energy (fatigue)
  • urinary tract infection
  • nausea
  • acne
  • diarrhea
  • falls
  • bronchitis
  • flu (influenza)
  • joint pain (arthralgia)
  • back pain

Please see the Full Prescribing Information, including BOXED WARNING, and Medication Guide.