Long‐term efficacy and safety of baricitinib in patients with severe alopecia areata: 104‐week results from BRAVE‐AA1 and BRAVE‐AA2
M. Senna, A. Mostaghimi, M. Ohyama, R. Sinclair, Y. Dutronc, W. S. Wu, G. Yu, C. Chiasserini, N. Somani, K. Holzwarth, B. King - Infectious Diseases
- Dermatology
Abstract
Background
Efficacy of the Janus kinase (JAK) inhibitor baricitinib for severe alopecia areata (AA) continuously increased over 52 weeks in two Phase 3 trials. There are limited long‐term data on JAK inhibitors in AA.
Objectives
To evaluate efficacy and safety of baricitinib for severe AA through 104 weeks of continuous therapy.
Methods
Integrated data from the BRAVE‐AA1 and BRAVE‐AA2 Phase 3 trials included adults with Severity of Alopecia Tool (SALT) scores ≥50 (≥50% scalp hair loss) randomized to and continuously treated with 2‐mg or 4‐mg baricitinib through Week 104. Patients who qualified to remain on continuous treatment included subjects who achieved SALT score ≤20 at Week 52 (Week‐52 responders; 2‐mg: N = 65; 4‐mg: N = 129) and baricitinib 4‐mg‐treated patients who had SALT score >20 at Week 52 but achieved SALT score ≤20 at prior visit(s) and/or had significant improvement in eyebrow or eyelash hair growth relative to baseline by Week 52 (Week‐52 mixed responders; N = 110). Week‐104 outcomes included the proportion of patients achieving SALT score ≤20 (≤20% scalp hair loss). Data were censored after treatment discontinuation.
Results
Among baricitinib 4‐mg‐treated and baricitinib 2‐mg‐treated Week‐52 responders, 90.7% and 89.2%, respectively, maintained SALT score ≤20 at Week 104. Among Week‐52 mixed responders, 39.1% reached SALT score ≤20 by Week 104. Continued improvement in eyebrow and eyelash regrowth was observed across groups. The most frequent treatment‐emergent adverse events were COVID‐19, upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection and creatine phosphokinase increase.
Conclusions
Baricitinib demonstrated a high level of maintenance of efficacy over 104 weeks in patients with severe AA. Efficacy increased in Week‐52 mixed responders, illustrating that long‐term treatment is necessary to observe maximum benefit in some patients. No new safety signals were observed.