This marks the first FDA approval of a systemic treatment for alopecia areata.
The FDA has approved baricitinib (Olumiant; Eli Lilly and Company), an oral Janus kinase (JAK) inhibitor, to treat patients with alopecia areata (AA). This is the first FDA approval of a systemic treatment for AA.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, MD, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, in the press release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
This autoimmune disorder makes the hair fall out as the body attacks the hair follicles. The data behind the approval comes from 2 trials, AA-1 (NCT03570749) and AA-2 (NCT03899259), which were randomized, double-blind, placebo-controlled trials containing patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than 6 months. Those in the trial were placed into 1 of 3 arms—placebo, 2 mgs of baricitinib, or 4 mgs baricitinib—every day. The key primary endpoint of the trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.
In the first trial it was found:
In the second trial it was found:
Common adverse events included, according to press release, upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase, urinary tract infection,liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster) and weight increase.
FDA approves first systemic treatment for alopecia areata. FDA. Published June 13, 2022. Accessed June 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata