1. Oral baricitinib is superior to placebo for hair regrowth at 36 weeks.

2. Oral baricitinib resulted in less severity of alopecia areata compared to placebo.

Evidence rating level: 1 (Excellent)

Summary of the study: Alopecia areata is an autoimmune disease that causes non-scarring hair loss that can affect any hair site, which can cause emotional and psychosocial distress. Extensive alopecia is unlikely to recover without treatment, which currently consists of glucocorticoids, other immunosuppressive agents, and contact immunotherapy, which are not FDA approved. Baricitinib, a reversible inhibitor of JAK1 and JAK2, has been postulated to reverse hair loss in patients with alopecia areata in previous reports. However, there is a lack of knowledge about understanding the effectiveness of baricitinib in causing hair regrowth in patients with alopecia areata. This study found that once-daily oral baricitinib was superior to placebo for hair regrowth after 36 weeks. This study was limited by factors such as some assessments performed remotely due to the Covid-19 pandemic, as well as a selective study population since patients with prior inadequate response to oral JAK inhibitors and patients with an episode lasting at least 8 years without any hair regrowth was excluded from the study. Nevertheless, the results of these studies are significant, as they demonstrate that baricitinib was superior to placebo for hair regrowth in patients with alopecia.

Click to read the study in the NEJM

Relevant reading: Genetic susceptibility to alopecia

In depth [randomized control trial]: This randomized controlled trial studied 1200 patients with severe alopecia. Patients who had a Severity of Alopecia Tool (SALT) score of 50 or greater, with 0 representing no scalp hair loss and 100 representing complete scalp hair loss, and a current episode of alopecia areata during more than 6 months to less than 8 years without spontaneous improvement in the previous 6 months were eligible for the study. Patients who had a diffuse pattern of alopecia areata or who had been treated with agents such as topical glucocorticoids within 1 week prior to randomization, systemic glucocorticoids within 8 weeks prior to randomization, and JAK inhibitors within 4 to 8 weeks prior to randomization, or who had an inadequate response to oral JAK inhibitors, were excluded from the study. The primary outcome measured was a SALT score of 20 or less at week 36, which was identified as a significant treatment outcome for patients with severe alopecia. The results of the primary analysis were assessed via graphical test patterns and power analysis with the use of logistic regression and analysis of covariance. Based on the analysis and two trials (BRAVE-AA1 and BRAVE-AA2) conducted, 38.8% of patients receiving baricitinib 4 mg daily, 22.8% of patients receiving baricitinib 2 mg daily, and 6, 2% of patients receiving placebo had a SALT score of 20 or less at week 36 in the BRAVE-AA1 trial. In the BRAVE-AA2 trial, 35.9% of patients receiving 4 mg baricitinib, 19.4% of patients receiving 2 mg baricitinib daily, and 3.3% of patients receiving placebo had an SALT score of 20 or less at Week 36. The difference between baricitinib 4 mg and placebo was 32.6% (95% confidence interval [CI], 25.6 to 39.50 and the difference between 2 mg baricitinib and placebo was 16.6% (95% CI, 9.5 to 23.8) in the BRAVE-AA1 trial. In the BRAVE-AA2 trial, the difference between baricitinib 4 mg and placebo was 32.6% (25.6 to 39.6) and 16.1% (95% CI, 9.1 to 23.2) between baricitinib 2 mg and placebo. Overall, this study demonstrated that once-daily oral baricitinib was superior to placebo for hair regrowth, although longer trials are needed to determine the efficacy and safety of baricitinib for alopecia areata, with trial durations of 200 weeks recommended.

Picture: PD

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