43046 Outcomes of Down-Titration in Patients with Severe Scalp Alopecia Areata Treated with Baricitinib 4 Mg: Week 104 Data from BRAVE-AA2

Baricitinib (2mg and 4mg, once‐daily), an oral, selective, Janus kinase 1/2 inhibitor, was superior to placebo at achieving hair regrowth in patients with severe alopecia areata (AA) at Week‐36 [1]. Here we report Week‐104 efficacy results from the down‐titration portion of BRAVE‐AA2 (NCT03899259), a randomized, double‐blind, placebo‐controlled phase 3 trial. BRAVE‐AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). At Week‐52, patients initially randomized to baricitinib 4mg who were responders (SALT score ≤20) were rerandomized 1:1 to stay on 4mg or down‐titrate to 2mg. Retreatment to initial baricitinib dose was automatically triggered by a worsening of Week 52 SALT score >20 points (“loss of treatment benefit”). Descriptive statistics are summarized using observed data and multiple imputation. At Week‐52, 86/234 baricitinib 4mg treated patients were responders. Following rerandomization, 44 patients remained on baricitinib 4mg, and 42 down‐titrated to baricitinib 2mg. At Week‐104, a SALT score ≤20 was maintained in 90.2% of responders who remained on baricitinib 4mg. Overall, 45.2% of patients who down‐titrated to baricitinib 2mg experienced a loss of treatment benefit by Week‐104. For patients who had achieved SALT score ≤20 by Week‐36 and maintained it up to Week‐52 (sustained response) loss of treatment benefit occurred in 39.4% (13/33) compared to 66.7% (6/9) for patients who had not. During 36 weeks of retreatment, 71.4% (5/7) recaptured SALT score ≤20. These data help to inform decisions on down‐titration, however, more work will be needed to better define timing and conditions for successful downtitration.