First Systemic Treatment of Alopecia Areata Approved
The FDA has approved baricitinib (Olumiant) oral tablets to treat adult patients with severe alopecia areata, the first approval of a systemic treatment for the condition. Baricitinib is a product of Eli Lilly. It was originally approved in 2018 for the treatment of certain adult patients with moderately to severely active rheumatoid arthritis. Baricitinib is a Janus kinase (JAK) inhibitor.
The approval was based on data from two randomized, double-blind, placebo-controlled trials with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than 6 months. Patients in the trials received either a placebo, 2 mg Olumiant, or 4 mg Olumiant every day. The primary efficacy end point for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.
- In the first trial, 22% of the 184 patients who received 2 mg baricitinib and 35% of the 281 patients who received 4 mg of the medication achieved adequate scalp hair coverage, compared with 5% of the 189 patients who received placebo.
- In the second trial 17% of the 156 patients who received 2 mg baricitinib and 32% of the 234 patients who received 4 mg of the drug achieved adequate scalp hair coverage, compared with 3% of the 156 patients who received a placebo.
The most common side effects associated with baricitinib include upper respiratory tract infections, headache, acne, hyperlipidemia, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, Candida infections, anemia, neutropenia, abdominal pain, shingles, and weight increase.
Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. For detailed prescribing information and warnings and precautions, consult product labeling.