RCT: Nemolizumab Plus Topical Therapy Improves Skin Clearance, Itch, and Sleep in Moderate-to-Severe Atopic Dermatitis – The Lancet

Study Design and Population: This study reports on two identical 48-week, double-blind, randomized, placebo-controlled phase 3 trials (ARCADIA 1 and ARCADIA 2) involving 1,728 adolescents and adults with moderate-to-severe atopic dermatitis and pruritus unresponsive to topical corticosteroids. Participants were randomized 2:1 to receive nemolizumab (an IL-31 receptor antagonist) or placebo, alongside background topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI).

Main Findings: At week 16, nemolizumab significantly improved primary outcomes compared to placebo, with a higher proportion achieving clear or almost clear skin (IGA success) and a 75% improvement in Eczema Area and Severity Index (EASI-75). Nemolizumab also showed significant early and sustained improvements in itch and sleep. The safety profile was comparable between groups, with treatment-emergent adverse events occurring in about half of the participants.

Implications for Practice: Nemolizumab, in combination with TCS-TCI, demonstrated robust efficacy in reducing inflammation, itch, and sleep disturbances in moderate-to-severe atopic dermatitis. If approved, it could provide an important addition to current treatment options, particularly for patients inadequately managed by existing therapies.

Reference: Silverberg JI, Wollenberg A, Reich A, et al. (2024). Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet, 404(10451), 445-460. DOI: 10.1016/S0140-6736(24)01203-0.