The United States Food and Drug Administration (FDA) recently granted approval to Olumiant (baricitinib) oral tablets as a systemic treatment for adult patients with severe alopecia areata. This marks the first time the FDA has approved a systemic treatment for this autoimmune disorder, which affects more than 300,000 people in the US. Alopecia areata is a condition that causes patchy baldness and is caused by the body attacking its own hair follicles. Olumiant is a Janus kinase inhibitor (JAK) that blocks the activity of one or more enzymes from a specific family and interferes with the pathway that leads to inflammation.
In two clinical trials, 22-35% of patients who received 2-4 milligrams of Olumiant achieved adequate coverage of hair and scalp, compared to only 5-3% of patients who received a placebo. The drug comes with warnings and precautions, such as close monitoring for signs and symptoms of infection during and after treatment; evaluating patients for active TB infection and testing for latent tuberculosis before treatment with Olumiant; and the possibility of viral reactivation. Other warnings and precautions include hypersensitivity (allergic reactions), gastrointestinal perforations (tears in the stomach or intestine), and laboratory abnormalities, such as low white and red blood cell counts, increased liver enzymes, and increased lipids. Olumiant also carries a warning box for serious infections, mortality, malignancies, serious adverse cardiovascular events and thrombosis.
In addition to Olumiant, pharmaceutical companies such as Pfizer and Concert Pharmaceuticals are working on drugs similar to Oluminant to treat alopecia areata. In a clinical trial with 1,200 patients, more than half of them allowed their hair to grow back after a year. Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia areata. Today's approval of Olumiant will help meet this unmet need.
People with the disorder can now rely on this drug to control their condition.