No new safety signals or reports of deaths, thromboembolic events, or major cardiovascular events reported<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b>
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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.<\/p>\n
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 (\u226550 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.<\/p>\n
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 \u226420 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.<\/p>\n
“Ivarmacitinib, at 4-mg and 8-mg doses, demonstrated significant efficacy and tolerability in patients with severe AA,” the authors write.<\/p>\n
The study was funded by Jiangsu Hengrui Pharmaceuticals, the developer of ivarmacitinib.<\/p>\n