Main Article Content
Introduction: In pivotal BRAVE-AA1 and AA2 phase 3 clinical trials, the Janus kinase (JAK)1/JAK2 inhibitor baricitinib has demonstrated efficacy in achieving clinically meaningful regrowth of hair in patients with severe alopecia areata. While a significant proportion of patients achieve regrowth by weeks 36 and 52 on baricitinib versus placebo, other patients, particularly those with longer episode duration or with higher disease severity, require more time on therapy to see full treatment benefit. The treatment benefit and distribution of SALT scores at Week 52 across the spectrum of responders is reported here.
Methods: Adults with Severity of Alopecia Tool (SALT) score ≥50 (≥50% scalp hair loss) were enrolled into BRAVE-AA1 and BRAVE-AA2. Patients were randomized 2:2:3 to receive once-daily placebo (N=345), baricitinib 2 mg (BARI-2MG) (N=340), or baricitinib 4 mg (BARI-4MG) (N=515). Patients randomized to baricitinib retained their treatment allocation through Week 52. Pooled outcomes were assessed by baricitinib group and in patients with SALT score ≤20 versus SALT score >20 at Week 52. Median and interquartile range (IQR) of SALT scores was assessed with last observation carried forward.
Results: At baseline, the median SALT score across 1200 randomized patients was 96 (near-total hair loss), with 638 (53.2%) having SALT score 95-100. At Week 52, 24.1% of patients who received BARI-2MG and 41.6% of patients who received BARI-4MG had SALT score ≤20; median (IQR) absolute SALT scores in this group were 7 (1-12) with BARI-2MG treatment and 3 (0-11) with BARI-4MG treatment. 17.9% of patients who received BARI-2MG and 18.8% of patients who received BARI-4MG patients achieved SALT scores of 21-49 at Week 52; median (IQR) scores were 34 (27-41) following BARI-2MG treatment and 31 (26-42) following BARI-4MG treatment.
Conclusions: While a significant proportion of patients achieved SALT ≤20, the findings of this analysis indicate that partial benefit across scalp hair regrowth is achieved even if patients do not meet clinical response criteria of SALT ≤20. There is a substantial proportion of patients who demonstrate movement towards improvement across the SALT score spectrum. In these patients, a longer treatment course may be necessary to achieve optimal treatment outcomes.
Funded by Eli Lilly and Company.
2. King B, et al. N Engl J Med. 2022;386:1687-1699.
3. Bieber T, et al. Adv Ther. 2022;39:4910–60.