Oral baricitinib bests placebo in severe alopecia areata treatment
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A 4 mg dose of baricitinib was associated with significant improvement compared with placebo in alopecia areata disease severity, according to a study.
“Alopecia areata is an autoimmune disorder marked by disfiguring, nonscarring hair loss, and there are no therapies approved by the FDA for treatment of the disease,” Brett King, MD, PhD, of the Yale School of Medicine, told Healio. “JAK inhibitors are showing promise for treatment of severe alopecia areata.”
Baricitinib (Olumiant, Lilly) is an oral, selective, reversible JAK inhibitor that may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata.
To investigate the utility of JAK inhibitors in this patient population, King and colleagues conducted BRAVE-AA1 and BRAVE-AA2, two randomized, placebo-controlled, phase 3 trials.
The 654 eligible participants from BRAVE-AA1 and 546 in BRAVE-AA2 had a Severity of Alopecia Tool (SALT) score of 50 or higher, where the range was from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Study protocols called for once daily baricitinib 4 mg or 2 mg or placebo in a 3:2:2 ratio. A SALT score of 20 or less at week 36 served as the primary endpoint.
Results from BRAVE-AA1 showed that the 4 mg dose yielded the primary endpoint in 38.8% of the cohort, while the 2 mg dose yielded this result in 22.8%. By comparison, just 6.2% of patients in the placebo arm reached a SALT score of 20 or less.
In BRAVE-AA2, the primary endpoint was reached by 35.9% of patients in the 4 mg baricitinib group, 19.4% of those in the 2 mg group and 3.3% of patients treated with placebo.
In BRAVE-AA1, the 4 mg dose of baricitinib bested placebo in the primary outcome measure by 32.6 percentage points (95% CI, 25.6-39.5). The difference between the 2 mg dose and placebo was 16.6% (95% CI, 9.5-23.8; P < .001 for each dose vs. placebo).
The difference between the 4 mg dose and placebo in BRAVE-AA2 was 32.6% (95% CI, 25.6-39.6). Also, the difference between 2 mg baricitinib and placebo was 16.1% (95% CI, 9.1-23.2; P < .001 for each dose vs. placebo).
“In adults with severe alopecia areata, treatment with baricitinib demonstrated scalp, eyebrow and eyelash hair regrowth,” King said. “Across both trials, approximately one-third and one-fifth of patients treated with baricitinib 4 mg and 2 mg, respectively, achieved 20% or less scalp hair loss during 36 weeks of treatment.”
King and colleagues reported that the 4 mg dose of baricitinib, but not the 2 mg dose, generally showed improvement over placebo in secondary measures including Scalp Hair Assessment Patient-Reported Outcome and the Clinician-Reported Outcome Measure for Eyebrow Hair Loss scores.
Safety data showed signals for acne along with elevated levels of creatine kinase and low- and high-density lipoprotein cholesterol were more frequently reported in patients treated with baricitinib compared with placebo.
“Hopefully, we will soon have treatment to reverse this often awful disease,” King said.
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