A phase 3 clinical trial has shown that ivarmacitinib, an oral selective Janus kinase 1 (JAK1) inhibitor, is effective in treating moderate to severe atopic dermatitis (AD) in adolescents and adults. The treatment also demonstrated a favorable safety profile. Researchers say these results highlight ivarmacitinib’s potential as a promising new therapy for patients with this chronic skin condition.
The findings were published in JAMA Dermatology. The study was designed as a multicenter, double-blind, placebo-controlled trial. It enrolled 336 patients between the ages of 12 and 75 across 53 clinical sites in Canada and China. The trial lasted 12 months, and participants were randomly assigned to receive either 4 mg or 8 mg of ivarmacitinib, or a placebo, once daily for 16 weeks.
At the end of the treatment period, both dosage groups showed significantly better outcomes compared to the placebo group. In the 8 mg group, 42.0% of patients achieved an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), with at least a two-grade improvement from baseline. In the 4 mg group, 36.3% reached this level, while only 9.0% of patients in the placebo group did the same.
The drug also showed strong results on the Eczema Area and Severity Index (EASI-75), which measures at least 75% improvement from baseline. In the 8 mg group, 66.1% of patients reached this target, while 54.0% did so in the 4 mg group. The placebo group showed a significantly lower response rate of 21.6%.
In terms of safety, the rate of treatment-emergent adverse events was similar across all three groups. Adverse events were reported in 69.0% of patients receiving 4 mg of the drug, 66.1% in the 8 mg group, and 64.9% in the placebo group. Serious adverse events occurred in 2.7% of patients in the 4 mg group, 1.8% in the 8 mg group, and 2.7% in the placebo group.
According to the researchers, these findings build on earlier phase 2 results and further support the development of ivarmacitinib as a targeted treatment for atopic dermatitis. They believe the drug could offer new hope for patients struggling with moderate to severe forms of this persistent inflammatory skin disease.
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