USA: A pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials revealed that severe alopecia areata patients not achieving successful regrowth of scalp hair with baricitinib, 2 mg, may benefit from up-titration to baricitinib, 4 mg.
The findings published in JAMA Dermatology showed that up-titration of baricitinib, 2 mg, to baricitinib, 4 mg, in patients who did not respond to the 2 mg dose led to meaningful improvement of response rates over the subsequent 24 weeks for eyebrow, scalp, and eyelash hair loss.
Baricitinib, an oral selective Janus kinase 1/2 inhibitor, has been shown to achieve clinically meaningful outcomes for eyebrow, scalp, and eyelash hair regrowth in patients with severe alopecia areata (AA) at 36 weeks of treatment. Treatment with 4 mg baricitinib has resulted in higher response rates than 2 mg baricitinib at weeks 36 and 52.
Justin M. Ko, Stanford University School of Medicine, Stanford, California, and colleagues aimed to determine the efficacy of up-titration of 4 mg baricitinib for 24 weeks in patients who had previously not responded to 2 mg baricitinib (Severity of Alopecia Tool score of >20).
BRAVE-AA1 and BRAVE-AA2 are placebo-controlled, multicenter, phase 3 randomized clinical trials (RCTs) that were initiated on September 24, 2018, and July 8, 2019, respectively, with follow-up to 200 weeks. The pooled analysis reports long-term extension data up to week 76.
The study included 1,200 adult patients with severe alopecia areata. They were randomly assigned in a ratio of 3:2:2 to receive baricitinib, 4 mg; baricitinib, 2 mg; or placebo. Patients treated with baricitinib remained on the same treatment dose until week 52. Patients were considered nonresponders to baricitinib, 2 mg if they had a SALT score higher than 20 after 52 weeks of therapy.
The analysis was done of the proportions of patients achieving a SALT score of 20 or below and clinician-reported outcomes for eyelash hair loss and eyebrow hair loss of 0 or 1 (minimal gaps or full coverage) with 2-point or higher improvements from baseline (among those with baseline scores ≥2 [significant gaps to no notable hair]) through week 76.
The authors reported the following findings:
At week 52, of the 340 patients (mean age, 38.4 years; 62.4% were females) treated with baricitinib, 2 mg, 62.4% had a SALT score higher than 20 and were up titrated to baricitinib, 4 mg.
Two-thirds of these patients (67.0%) had a baseline SALT score of 95 to 100, indicating very severe AA.
At week 76, 25.9% of patients had achieved a SALT score of 20 or lower.
During the same period, response rates for clinician-reported outcome scores of 0 or 1 increased from 19.3% to 37.9% for eyebrows and from 24.1% to 40.9% for eyelashes.
"Severe alopecia areata patients not achieving successful regrowth of scalp hair with baricitinib, 2 mg, may benefit from up-titration to baricitinib, 4 mg," the researchers concluded.
Reference:
Ko JM, Mayo TT, Bergfeld WF, et al. Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. JAMA Dermatol. 2023;159(9):970–976. doi:10.1001/jamadermatol.2023.2581