Baricitinib Achieved Complete/Near Complete Scalp Coverage in SALT Score ≤20 Responders: 52-Week Findings From BRAVE-AA Trials
Main Article Content
Keywords
Baricitinib, scalp, SALT
Abstract
Introduction: Baricitinib is an approved and widely used treatment option for severe alopecia areata (AA). In the Phase 2/3 BRAVE-AA1 (NCT03570749) and Phase 3 BRAVE-AA2 (NCT03899259) trials, a significant proportion of patients achieved the clinically meaningful endpoint of Severity of Alopecia Tool (SALT) score ≤20, and maintained it through Week 52. While SALT score ≤20 is a standard endpoint, it does not capture the full extent of patient improvement among responders. Many patients who achieved SALT score ≤20 in the BRAVE-AA trials, also achieved complete or nearly complete scalp coverage (SALT score ≤10 or ≤5). The objective of this analysis was to evaluate the proportion of patients achieving SALT score ≤10 or ≤5 among patients treated with baricitinib who achieved SALT score ≤20 through Week 52.
Methods: This analysis evaluated the proportion of patients achieving SALT score ≤10 or ≤5 among patients with severe AA pooled from the two BRAVE-AA trials who achieved SALT score ≤20 after treatment with baricitinib 4-mg or 2-mg at Weeks (W) 4, 8, 12, 16, 24, 36, and 52. Baseline demographics were evaluated to assess potential differences between patients with different levels of response. As-observed analyses used all collected data.
Results: Among patients treated with baricitinib 4-mg, the proportions of SALT score ≤20 responders who achieved SALT score ≤10 at W4, 8, 12, 16, 24, 36, and 52 were 0% (0/2), 44.4% (8/18), 46.0% (23/50), 52.4% (55/105), 67.5% (106/157), 74.6% (150/201), and 75.0% (171/228), respectively. The proportions achieving SALT score ≤5 were 0%, 16.7%, 26.0%, 31.4%, 51.6%, 55.2%, and 62.7% at W52, respectively among the SALT score ≤20 responders at each timepoint.
Among patients treated with baricitinib 2-mg, the proportions of SALT score ≤20 responders who achieved SALT score ≤10 at W4, 8, 12, 16, 24, 36, and 52 were 0% (0/2), 37.5% (3/8), 50.0% (7/14), 48.5% (16/33), 63.5% (33/52), 62.2% (51/82), and 71.0% (66/93), respectively. The proportions achieving SALT score ≤5 were 0%, 12.5%, 28.6%, 24.2%, 34.6%, 42.7%, and 47.3% at W52, respectively among the SALT score ≤20 responders at each timepoint. Patients achieving SALT score ≤10 or ≤5 tended to have less severe baseline disease characteristics relative to the overall population.
Conclusions: A significant proportion of patients who achieved SALT score ≤20 with baricitinib treatment also achieved complete or nearly complete scalp coverage, with some patients achieving this as early as Week 8. The proportion of complete or nearly complete responders increased over time with continued therapy.
References
2. Olsen EA, et al. J Am Acad Dermatol. 2004;51:440-447.