Ivarmacitinib efficacious, well tolerated in moderate-to-severe alopecia areata

Use of ivarmacitinib 4- and 8-mg doses for 24 weeks eases hair loss and is generally tolerated in patients with moderate or severe alopecia areata (AA), a phase II study has shown.

A team of investigators assessed the efficacy and safety of ivarmacitinib in adult AA patients with at least 25-percent scalp hair loss in this trial. Ninety-four eligible participants were randomly assigned in a 1:1:1:1 ratio to receive ivarmacitinib 2, 4, or 8 mg once daily or placebo for 24 weeks.

The percentage change from baseline in the Severity of Alopecia Tool (SAT) score at week 24 was the primary endpoint.

The least squares mean difference in the percentage change from baseline in the SAT score at week 24 was ‒30.51 percent (90 percent confidence interval [CI], ‒45.25 to ‒15.76) for ivarmacitinib 2 mg, ‒56.11 percent (90 percent CI, ‒70.28 to ‒41.95) for the 4-mg dose, ‒51.01 (90 percent CI, ‒65.20 to ‒36.82) for the 8-mg dose, and ‒19.87 percent (90 percent CI, ‒33.99 to ‒5.75) for placebo.

Notably, two serious adverse events occurred: follicular lymphoma and COVID-19 pneumonia.

The study was limited by its small sample size.

“AA is a CD8+ T cell–mediated autoimmune disease characterized by nonscarring hair loss,” the investigators said. “Ivarmacitinib, which is a selective oral Janus kinase 1 inhibitor, may interrupt certain cytokine signalling implicated in the pathogenesis of AA.”