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.

Nemolizumab with background topical therapy (corticosteroids±calcineurin inhibitors) significantly improved skin lesions, itch and sleep in two global phase 3 trials (ARCADIA 1&2) in adolescents and adults with moderate-to-severe atopic dermatitis through week (W)16. Efficacy and safety of nemolizumab, combined with background topical therapy, were evaluated for an additional 32 weeks (W16-W48) with a focus on maintained skin responses in clinical responders (patients achieving Investigator's Global Assessment [IGA] score of 0/1 [clear/almost clear] or ≥75% improvement in Eczema Area and Severity Index [EASI-75] at W16). At W16, clinical responders (N=507) to nemolizumab every 4 weeks (Q4W) were rerandomized (1 : 1 : 1) to receive nemolizumab 30 mg-Q4W/-Q8W/placebo (nemolizumab-withdrawal) subcutaneously with background topical therapy. At W48, 61.5% (strata-adjusted difference versus nemolizumab-withdrawal group [Δ], 11.8% [95% CI 1.3-22.3]) and 76.3% (Δ, 12.4% [95% CI 2.7- 22.0]) of patients in nemolizumab-Q4W; 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.