What question did this study set out to answer?

This research aims to evaluate the long-term efficacy and safety of nemolizumab in patients with moderate-to-severe atopic dermatitis over 48 weeks.

June 13, 2026Open Access

Efficacy and Safety of Nemolizumab at Week 48: Results from the Maintenance Phase of Two Global Phase 3 Pivotal Studies (ARCADIA 1&2) in Patients with Moderate-to-Severe Atopic Dermatitis

AWA WollenbergAugsburg University JSJonathan I. SilverbergGeorge Washington University FLFranz J. LegatMedical University of Graz

Key Points

This research aims to evaluate the long-term efficacy and safety of nemolizumab in patients with moderate-to-severe atopic dermatitis over 48 weeks.
Two global phase 3 trials, ARCADIA 1 and 2, with 507 clinical responders rerandomized to different nemolizumab dosing regimens.
Patients received nemolizumab 30 mg every 4 weeks, every 8 weeks, or placebo, combined with topical therapy.
Efficacy measured by Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) at weeks 16 and 48.
At week 48, 61.5% of patients receiving nemolizumab Q4W achieved IGA success compared to 49.7% in the withdrawal group (Δ, 11.8%, 95% CI 1.3-22.3).
74.3% of patients in the nemolizumab Q8W group maintained EASI-75 response versus 63.9% in the withdrawal group (Δ, 11.8%, 95% CI 2.1-21.5).
Adverse events were reported similarly across treatment groups, ranging from 53.5% to 58.3%.

Abstract

Nemolizumab with background topical therapy (corticosteroids±calcineurin inhibitors) significantly improved skin lesions, itch and sleep in two global phase 3 trials (ARCADIA 1 60.4% (Δ, 10.7% 95% CI 0.3-21.0) and 75.7% (Δ, 11.8% 95% CI 2.1-21.5) in nemolizumab-Q8W; and 49.7% and 63.9% in nemolizumab-withdrawal group maintained response rate for IGA success and EASI-75, respectively. The percentage of patients who experienced ≥1 adverse events were similar across the groups (range: 53.5%-58.3%). Up to W48, skin responses were maintained without notable differences in the safety profile of both nemolizumab dosing regimens.

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