Alopecia areata: 1-year baricitinib treatment increases success

Long-term results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials demonstrated that extended treatment of alopecia areata with baricitinib for up to 52 weeks increased the percentage of patients responding with regrowth of hair. Benefits were not only observed on the scalp but also in the eyebrows and eyelashes.

As the Janus kinase (JAK)-dependent cytokines IL-15 and IFN-γ form part of the pathogenesis of alopecia areata, JAK inhibition is a recent focus of treatment research [1–3]. “Every meeting we are getting closer and closer to approved therapies for our patients, who are suffering from this disease,” Prof. Brett King (Yale School of Medicine, CT, USA) said [4].

Prof. King presented the 52-week data from the extension periods of the phase 3 BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) trials investigating the oral, selective JAK1/2 inhibitor baricitinib for alopecia areata over 36 weeks. In the primary investigations, 1,200 adults with ≥50% hair loss, assessed with the Severity of Alopecia Tool (SALT) score, were randomised (2:2:3) to a once-daily placebo, 2 mg, or 4 mg of baricitinib. At week 36, SALT score ≤20 was achieved overall by 34% of baricitinib 4 mg and 22.6% of baricitinib 2 mg treated participants. The results for SALT score ≤10 were 24.9% and 15.3%, respectively [1]. “If you see where these patients came from, 10% or less scalp hair loss is almost eradicating the disease,” commented Prof. King.

The results from the long-term extensions, in which patients previously on placebo were also treated with baricitinib, were even more promising: 39% (4 mg) and 22.6% (2 mg) of participants reached a SALT score ≤20 [4]. A SALT score ≤10 was achieved by 28.9% and 15.3% of participants, respectively (see Figure) [4]. In terms of regrowing eyelashes and eyebrows, Clinician-Reported Outcomes of 0/1 hair loss on the higher dose of baricitinib improved from 33.6% (eyelashes) and 33.0% (eyebrows) at week 36 to 45.3% and 44.1% at week 52.

Figure: BRAVE-AA1 and BRAVE-AA2 outcomes up to week 52. Images kindly provided by Prof. King



“Safety-wise, the 52-week data looked like the 36-week data,” Prof. King pointed out. The most frequent adverse events in the extension phase were upper respiratory infections, nasopharyngitis, headache, and acne [5]. The researchers stated that there were no deaths, nor cases of venous thromboembolism, tuberculosis, opportunistic infection, or gastrointestinal perforation.

In conclusion, treatment with baricitinib for up to 52 weeks further increased the rate of patients whose hair regrew, and the concomitant safety evaluations did not reveal new safety concerns [4,5].

1. 
   
   1. King B, et al. N Engl J Med 2022;Mar 26. DOI: 1056/NEJMoa2110343.
   2. de Oliveira AB, et al. Dermatol Ther. 2019;32(5):e13053.
   3. Damsky W, King B. J Am Acad Dermatol. 2017;76(4):736–744.
   4. King B. Long-term efficacy of baricitinib in patients with severe alopecia areata: week-52 results from BRAVE-AA1 and BRAVE-AA2. S026, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.
   5. King B, et al. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. P33966, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.

 

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Posted on 17 May, 202228 March, 2024