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

Abstract

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.