Ivarmacitinib shows favourable risk–benefit profile in AD

The selective oral Janus kinase 1 (JAK1) inhibitor ivarmacitinib helps improve the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adolescent and adult patients, while having a manageable safety profile, according to a phase III trial.

The trial included 336 patients aged 12 to 75 years (mean age 31.1 years, 63.4 percent male, 85.1 percent Asian) with moderate to severe AD. They were randomly assigned to receive ivarmacitinib at 4 mg (n=113) or 8 mg (n=112) or placebo (n=111) once daily for 16 weeks.

Co-primary endpoints were the proportions of patients achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline and a 75-percent improvement in Eczema Area and Severity Index score (EASI-75) at week 16.

At week 16, significantly more ivarmacitinib-treated patients achieved an IGA score of 0 or 1 with at least a 2-grade improvement compared with those who received placebo: 36.3 percent with the 4-mg dose and 42.0 percent with the 8-mg dose vs 9.0 percent (p<0.001 for both comparisons). Likewise, EASI-75 responses were also significantly higher in the ivarmacitinib groups: 54.0 percent and 66.1 percent vs 21.6 percent; p<0.001 for both comparisons.

Treatment-emergent adverse events occurred in 69.0 percent of patients in the 4-mg ivarmacitinib group, 66.1 percent in the 8-mg group, and 64.9 percent in the placebo group. Serious treatment-emergent adverse events were documented in 2.7 percent, 1.8 percent, and 2.7 percent, respectively.