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Introduction: Baricitinib is approved for the treatment of patients with severe alopecia areata (AA). The efficacy results from the down-titration portion of the phase 3 trial BRAVE-AA2 have been reported up to Week-104. Here we report both long-term efficacy outcomes from the down-titration portion of BRAVE-AA2, and recapture data after retreatment.
Methods: BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). At Week-52, patients initially randomized to 4mg baricitinib who had scalp hair response (Responders: SALT score ≤20) were eligible to be rerandomized 1:1 to remain on 4mg or down-titrate to 2mg. Retreatment with baricitinib 4mg for those patients who were down-titrated was triggered by a loss of treatment benefit defined as a 20 points or greater worsening in SALT score from Week-52. Last observation carried forward was used to impute missing or censored data.
Results: Among 86 responders at Week-52, 42 were down-titrated from 4mg to 2mg baricitinib. At Week-104 and 152 respectively, 66% and 59% of down-titrated patients had maintained a SALT score ≤20, compared to 91% and 89% of responders who remained on baricitinib 4mg. Among down-titrated patients, at Weeks 104 and 152, 29% and 37% experienced a loss of treatment benefit, respectively. For patients that remained on 4mg baricitinib, these proportions were 5% and 7%. Among patients who had achieved a SALT score ≤20 by Week-36 and had maintained it up to Week-52 before down-titration (sustained response), loss of treatment benefit by Week-152 occurred in 33% (11/33), compared to 50% (4/8) among patients who had not achieved sustained response. Among patients experiencing loss of benefit and retreated with baricitinib 4mg, the proportion of patients recapturing SALT score ≤20 increased over time, reaching 67% (10/15) for patients with ≥48 weeks of retreatment.
Conclusions: These data show that more than half of patients down-titrated to 2mg maintained clinical response up to 2 years after the down-titration. While more work is needed to define timing and conditions for a successful down-titration, data suggests that dosing of baricitinib can be modulated between 2mg and 4mg to adapt to the clinical response.
Funded by Eli Lilly and Company.
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