Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial

Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD). This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments. This was a post-hoc analysis of a phase III clinical trial of Ivarmacitinib in moderate-to-severe AD (NCT04875169). Subgroup analysis by with (N = 132) or without (N = 204) previous systemic treatments (systemic corticosteroids, biologics, or other immunomodulators) was performed. In patients with previous systemic treatments, Ivarmacitinib 8 mg (n = 34) and 4 mg (n = 53) exhibited higher Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)-75, EASI-90, and Worst Itch Numeric Rating Scale (WI-NRS) 4 response rates, and a greater reduction in Dermatology Life Quality Index (DLQI) score compared with placebo (n = 45) at most timepoints from W4 to W16. In patients without previous systemic treatments, these outcomes were notably increased in Ivarmacitinib 8 mg (n = 78) and 4 mg (n = 60) versus placebo (n = 66) throughout W4 to W16. The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments. Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments.