Outcomes of down-titration in patients with severe scalp alopecia areata initially treated with baricitinib 4-mg: Week 152 data from BRAVE-AA2

Background: Baricitinib, an oral selective Janus kinase inhibitor, is approved to treat adults with severe alopecia areata (AA). Objective: To report the week 152 efficacy results from the phase 3 trial BRAVE-AA2 down-titration substudy. Methods: BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). Baricitinib 4-mg-treated patients achieving a clinical response (SALT score ≤20) at week 52 were rerandomized 1:1 to stay on 4-mg or down-titrate to 2-mg. The last observation carried forward was used to impute missing or censored data. Results: At week 52, 86/234 (36.8%) baricitinib 4-mg-treated patients were eligible for down-titration; 44 remained on 4-mg while 42 down-titrated to 2-mg. At week 152, 39/44 (88.6%) 4-mg-treated patients had maintained clinical response, compared to 24/41 (58.5%) down-titrated patients. Among down-titrated patients, loss of treatment benefit was less frequent in those with sustained response and SALT score ≤5 at week 52. Limitations: Method and timing of down-titration were prespecified in the protocol based on week 52 responder status and not on other clinical factors. Conclusion: More than half of down-titrated patients maintained response. Sustained treatment response and/or near-total regrowth may be associated with a greater likelihood of response maintenance after down-titration.