Ivarmacitinib in patients with moderate to severe atopic dermatitis stratified by baseline characteristics: a post-hoc analysis of a phase 3 clinical trial.

Abstract

Background: Ivarmacitinib (SHR0302) is a novel and highly selective Janus kinase 1 inhibitor for treating moderate to severe atopic dermatitis (AD).

Objective: This study aimed to evaluate the impacts of patient characteristics on the efficacy and safety of Ivarmacitinib.

Methods: This post-hoc analysis used data from a randomized, double-blind, placebo-controlled, multicenter phase 3 trial of Ivarmacitinib in patients with moderate to severe AD in which patients were randomized (1:1:1) to receive Ivarmacitinib 4 mg or 8 mg or placebo for 16 weeks. Subgroup analyses were conducted based on baseline characteristics.

Results: At week 16, both Ivarmacitinib 4 or 8 mg showed better efficacy over placebo in achieving Eczema Area and Severity Index (EASI) 75, EASI 90, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥4-point responses in most subgroups based on age, sex, body mass index, AD duration, Investigator's Global Assessment score, EASI score, WI-NRS score, body surface area involvement, history of comorbid allergies, or previous systemic therapies. The overall incidence of adverse events and most of the adverse events of special interest were similar between Ivarmacitinib and placebo across all subgroups.

Conclusion: Ivarmacitinib demonstrated efficacy and good tolerability in treating moderate to severe AD with diverse patient characteristics.