Nemolizumab improves skin lesions, itch, and sleep disturbance in patients with moderate-to-severe atopic dermatitis (AD), according to results from two phase 3 studies.
Galderma’s nemolizumab is a first-in-class interleukin-31 receptor alpha antagonist that is under investigation for atopic dermatitis.
The research was presented by Jonathan I Silverberg, MD, Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine in Washington, DC, during the late breaker session at Maui Derm 2024.
The two 48-week randomized, placebo-controlled double-blind, phase 3 studies, ARCADIA 1 and ARCADIA 2 (N=787) comprised a 16-week initial treatment period followed by a 32-week maintenance period.
Patients (≥12 years old) with moderate-to-severe AD and associated pruritus were assigned (2:1) to either nemolizumab 30 mg (60 mg at baseline or placebo administered subcutaneously every 4 weeks) with concomitant background topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) of medium/low potency. The co-primary endpoints were Investigator’s Global Assessment (IGA) success (IGA score of 0/1 [clear/almost clear skin] with a reduction of ≥2 points from baseline at Week 16 and 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 16. Key secondary endpoints included evaluation of itch response (≥4-point improvement in peak pruritus numeric rating scale [PP NRS] score at Week 16 and earlier timepoints) and improvement in sleep disturbance (≥4-point improvement in sleep disturbance numeric rating scale score [SD NRS]) at Week 16. Safety was assessed throughout the study.
Both studies met the co-primary, and key secondary endpoints with the outcomes being consistent between studies. At Week 16, a significantly greater proportion of nemolizumab-treated patients achieved clinically meaningful improvements in skin lesions in ARCADIA 1 and 42.1% vs 30.2% in ARCADIA 2 when compared with placebo. A significantly higher proportion of nemolizumab-treated patients showed early and sustained improvement in itch, the studies showed. In addition, improvement in sleep disturbance was observed in a significantly higher proportion of patients in the nemolizumab group at Week 16. The safety profile was consistent between nemolizumab- and placebo-treated arms, most treatment-emergent adverse events were non serious, and mild or moderate in severity.
