FDA Approves Lisraya, an Oral Pill to Treat Adults With Dermatomyositis

What Is Lisraya and How Does It Work?

The FDA has approved Lisraya (brepocitinib) to treat adults with dermatomyositis, a rare autoimmune disease. It causes the body’s immune system to attack its own muscles and skin. People with this condition often suffer from painful muscle weakness and distinctive skin rashes. Until now, patients had limited options and relied mostly on treatments made for other conditions.

Lisraya is a daily pill taken by mouth. It belongs to a class of drugs known as Janus kinase (JAK) inhibitors. The drug works by blocking specific signals in the body that cause inflammation. By stopping these signals, Lisraya helps reduce the inflammation that damages muscle tissue and skin.

Why Was Lisraya Approved?

The approval was based on a 52-week clinical study involving 241 adults with dermatomyositis. Patients were split into groups to take either Lisraya or an inactive treatment called a placebo. Researchers tracked overall disease changes using a special scoring system. This score looked at muscle strength, skin health, blood tests, and physical function.

At the end of the study, patients who took Lisraya had significantly greater improvement in their symptoms compared to those who took the placebo. People taking Lisraya had better muscle function and clearer skin. They were also able to lower their use of steroid medications better than those on the placebo.During the main study period, 6% of patients taking Lisraya stopped treatment due to side effects, compared to 11% of patients taking the placebo. Common side effects in the study included cold-like infections, headaches, fatigue, and nausea. Lisraya carries strong warnings for serious risks, including severe infections, heart problems, blood clots, cancer, and an increased risk of death seen with similar JAK inhibitors.

What Do I Need to Know About Taking Lisraya?

You take Lisraya once daily by mouth, either with or without food. Before starting treatment, your healthcare provider will run blood tests to check your blood counts, liver function, and kidney health. They will also check you for hidden infections like tuberculosis and hepatitis. You should make sure all your vaccines are up-to-date before starting this drug, as you must avoid live vaccines while taking it.

Because Lisraya can lower your body’s ability to fight off germs, you should tell your healthcare provider right away if you notice any signs of infection, such as fever, cough, or painful skin rashes. Patients with diabetes should monitor their blood sugar closely, as Lisraya may cause low blood sugar levels. Tell your healthcare provider if you have a history of heart issues, blood clots, or stomach ulcers.If you are pregnant, planning to become pregnant, or breastfeeding, speak with your healthcare provider. Lisraya can harm a fetus. If you can get pregnant, you must use effective birth control during treatment and for three days after their final dose. Do not breastfeed while taking Lisraya and for three days after stopping.