LONG-TERM EFFICACY AND SAFETY OF NEMOLIZUMAB UP TO 2 YEARS IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS: PIVOTAL TRIAL SUBGROUP ANALYSIS OF THE ARCADIA LTE

Document Type

Conference Proceeding

Publication Date

10-23-2025

Publication Title

Acta Derm Venereol

Keywords

nemolizumab, adult, adverse drug reaction, atopic dermatitis, Children's Dermatology Life Quality Index, conference abstract, drug therapy, female, human, major clinical study, male, multicenter study, phase 3 clinical trial, prognosis, pruritus, randomized controlled trial, sensitivity analysis, Severity Scoring of Atopic Dermatitis, side effect, skin defect, sleep debt, sleep disorder

Abstract

Introduction: Long-term clinical data on treatments for atopic dermatitis (AD) are crucial to inform prognosis, guide treatment decisions and plan healthcare resources. The ARCADIA longterm extension (LTE) study (NCT03989206) assessed safety and efficacy of nemolizumab in a heterogeneous population of patients with moderate-to-severe AD, enrolled from several Phase 2/3 studies. Objective: To assess safety and efficacy in a more homogeneous subgroup comprising only patients enrolled from the ARCADIA Phase 3 trials. Method: This pre-planned subgroup analysis included patients who were either nemolizumab-previously experienced (NPE) or nemolizumab-naïve (NN). All patients received nemolizumab Q4W in the LTE. Efficacy endpoints included IGA score 0/1, EASI-50/75/90 (from lead-in baseline), ≥ 4-point improvement from lead-in baseline in SCORAD VAS pruritus/sleep loss, SCORAD VAS pruritus/sleep loss score <2, and DLQI/cDLQI score 0/1. AEs were reported. Observed case data (up to W104) were used to summarise efficacy endpoints. Results: At data cutoff, 945/1433 (66%) patients completed W104. At W104, the proportion of NPE and NN patients achieving efficacy outcomes was 62% and 59% for IGA 0/1, 97% and 98% for EASI-50, 88% and 86% for EASI-75, 67% and 65% for EASI-90, 70% and 67% for SCORAD VAS pruritus <2, 87% and 82% for SCORAD VAS pruritus ≥ 4-point improvement, respectively. SCORAD VAS sleep loss showed similar results to pruritus. Sensitivity analyses (multiple imputation [missing at random]) of IGA score 0/1 and EASI-50/75/90 at W56 showed similar results. DLQI scores improved over time. Most AEs were non-serious and did not lead to study discontinuation, consistent with the overall LTE population. Conclusion: Treatment with nemolizumab up to W104 was well tolerated and associated with improvements in pruritus, skin lesions and sleep disturbance.

Volume

105

First Page

44

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