No new safety signals or reports of deaths, thromboembolic events, or major cardiovascular events reported
By Elana Gotkine HealthDay Reporter
THURSDAY, March 13, 2025 (HealthDay News) — For adults with severe alopecia areata (AA), ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, at doses of 4 and 8 mg is efficacious and tolerable, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida.
Jianzhong Zhang, M.D., of the Peking University People’s Hospital in Beijing, and colleagues examined the efficacy and safety of ivarmacitinib in adults with severe AA (≥50 percent scalp hair loss, including alopecia totalis/universalis) in a phase 3 trial. Three hundred thirty patients were randomly assigned to receive either daily oral ivarmacitinib (4 or 8 mg) or placebo for 24 weeks (109, 111, and 110 patients, respectively), followed by a double-blind extension phase of 28 weeks. After 24 weeks, patients receiving placebo were re-randomly assigned to ivarmacitinib 4 or 8 mg.
The researchers found that 34.9, 40.6, and 9.0 percent of those assigned to ivarmacitinib 4 mg, 8 mg, and placebo, respectively, achieved a Severity of Alopecia Tool score ≤20 at week 24. The response rate difference versus placebo was 25.6 and 31.6 percent, respectively, for ivarmacitinib 4 mg and 8 mg. Treatment-emergent adverse events occurred in 77.1, 84.7, and 75.5 percent of those assigned to ivarmacitinib 4 mg, 8 mg, and placebo, respectively, during the placebo-controlled period. No new safety signals emerged. No deaths, thromboembolic events, or major cardiovascular events were reported; one stage III follicular lymphoma case and one thyroid cancer case were reported with ivarmacitinib 4 mg and 8 mg, respectively.
“Ivarmacitinib, at 4-mg and 8-mg doses, demonstrated significant efficacy and tolerability in patients with severe AA,” the authors write.
The study was funded by Jiangsu Hengrui Pharmaceuticals, the developer of ivarmacitinib.
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