Ivarmacitinib Proves Effective in Treating Moderate to Severe Atopic Dermatitis

A phase 3 clinical trial has found ivarmacitinib, a selective oral Janus kinase 1 (JAK1) inhibitor, to be effective in treating moderate to severe atopic dermatitis (AD) in adolescents and adults. The drug was also shown to have a favorable safety profile. And the researchers say this demonstrates the potential of ivarmacitinib as a new therapeutic option for moderate to severe atopic dermatitis.

In a study published in JAMA Dermatology, the researchers described the multicenter, double-blind, placebo-controlled trial. They enrolled 336 patients aged 12 to 75 years across 53 sites in Canada and China for 12 months. The study team randomized participants (1:1:1) to receive either 4 mg or 8 mg of ivarmacitinib or placebo once daily for 16 weeks.

At the end of the treatment period, both ivarmacitinib groups showed significantly better outcomes than placebo:

42.0% of patients in the 8-mg group and 36.3% in the 4-mg group achieved an Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline, compared to just 9.0% in the placebo group.

Improvement in Eczema Area and Severity Index (EASI-75) was also notably higher in the treatment arms: 66.1% (8 mg) and 54.0% (4 mg) compared to 21.6% in the placebo arm.

Regarding the drug’s safety profile, treatment-emergent adverse events were reported at similar rates across all groups—69.0% in the 4-mg group, 66.1% in the 8-mg group, and 64.9% in the placebo group. Serious adverse events occurred in 3 patients (2.7%) in the 4-mg group, 2 (1.8%) in the 8-mg group, and 3 (2.7%) in the placebo group.

Results from this trial build on earlier phase 2 data and show ivarmacitinib’s potential as a targeted therapy for AD. According to the authors, the findings support further development of ivarmacitinib for use by patients struggling with this chronic inflammatory skin condition.

More details on the study can be found here.