What Is It, and Why Does It Matter?
The FDA has expanded the approval of Olumiant (baricitinib) to treat children 12 years and older who have severe alopecia areata. Alopecia areata is an immune disease that causes hair to fall out in patches or all over the body. Severe hair loss can be very hard on teens during their growing-up years. This decision gives young people and their families a new oral pill option to help hair grow back.
Olumiant belongs to a group of medicines called JAK inhibitors. In people with alopecia areata, the body's immune system attacks the hair follicles by mistake. Olumiant works inside cells to block signals that cause this immune attack. By calming down these signals, the medicine helps scalp hair, eyebrows, and eyelashes grow back.
Why Was It Approved?
The approval was based on a 36-week clinical study of 257 youths, ages 12 to 17 years, with severe alopecia areata. Before starting treatment, patients had complete or near-complete hair loss on their scalp. Researchers tested two different daily doses of Olumiant against a dummy pill, called a placebo.
The study looked at how many patients gained 80% or more scalp hair coverage. At week 36, 42% of teens taking the 4-milligram dose and 27% taking the 2-milligram dose reached this goal. In comparison, only 5% of teens taking the placebo reached it. Many teens taking the higher dose also saw improved eyebrow and eyelash hair. Side effects were similar to those seen in adult studies.
What Do I Need to Know?
Olumiant is a pill taken once daily with or without food. Common side effects in people treated for alopecia areata include common colds, sinus infections, headaches, acne, high cholesterol, and urinary tract infections. Patients may also get hair follicle inflammation or fatigue.
This medicine also carries serious risks. It can lower your body's ability to fight infections, including serious ones like tuberculosis. It may also increase the risk of blood clots, heart attacks, strokes, and certain cancers. Before starting Olumiant, your healthcare provider will run blood tests to check your blood cells, liver, and check for tuberculosis.
Tell your healthcare provider about all health conditions and medicines you take. Taking a medicine called probenecid or other drugs that affect the immune system can interact with Olumiant. You should not get live vaccines while taking this pill. If you are pregnant or planning to become pregnant, talk to your healthcare provider, as this drug may harm a fetus. Women should not breastfeed while taking Olumiant and for four days after the last dose.