Increased baricitinib dose improves alopecia in early nonresponders

Key takeaways:

• Pooled analysis of two phase 3 trials included 1,200 patients with severe alopecia areata.
• Patients who originally received 2 mg of baricitinib had an increased response with a 4 mg dose.

Pooled analysis of two clinical trials found patients with alopecia who did not respond to 2 mg of baricitinib had a significant improvement with a 4 mg dose.

“Alopecia areata (AA) is a common immune-mediated disorder marked by nonscarring hair loss that can affect any hair-bearing site, frequently causing considerable emotional and psychosocial distress,” Justin M. Ko, MD, MBA, of the department of dermatology at Stanford University School of Medicine, and colleagues wrote. “Baricitinib, an oral selective Janus kinase 1/2 inhibitor, is approved for the treatment of adults with severe AA and is in late-stage development for pediatric patients with severe AA.”

Pooled data from the BRAVE-AA1 and BRAVE-AA2 multicenter, placebo-controlled phase 3 randomized trials included 1,200 adult patients with severe AA wo were assigned to receive baricitinib 4 mg, baricitinib 2 mg or placebo. It includes long-term data up to extension week 76.

Patients in the placebo arm deemed nonresponders at week 36, defined by a Severity of Alopecia Tool (SALT) score of 20 or greater, were switched to baricitinib 2 mg or 4 mg. Patients in either treatment arm had no dose change through week 52, at which point 212 of the 340 patients (62.4%) in the 2 mg group were nonresponders and switched to a 4 mg dose.

The mean baseline SALT score was 90.1, with 142 (67%) patients classified as having very severe AA with a SALT score of 95 to 100. The mean SALT score at week 52 was 69.6.

Of those patients who were uptitrated from 2 mg baricitinib to 4 mg, 25.9% achieved a scalp SALT score of 20 or lower at week 76. Further, a scalp SALT score of 50 or lower was achieved by 38.7% of these patients, and a SALT score of 75 or lower was achieved by 26.4%.

Clinician-reported (ClinRo) measures for eyebrow and eyelash hair loss improvement of at least 2 points was achieved in 19.3% and 24.1% of the 2 mg group at week 52. Of these patients who were switched to the 4 mg dose at week 52, a ClinRo score of 0 or 1 with a 2-point or greater improvement increased to 37.9% for eyebrow hair loss and 40.9% for eyelash hair loss at week 76.

“In this pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials, uptitration was effective in increasing the response of scalp, eyebrow and eyelash hair regrowth in patients who

had not yet achieved at least 80% coverage of scalp after 52 weeks of therapy with baricitinib 2 mg,” the authors wrote. “Increasing the dose to baricitinib 4 mg allowed a larger number of patients to achieve clinically meaningful end points over the next 6 months.”