August 1, 2024

667 - Maintenance of efficacy and safety with nemolizumab at week 48: results from two global phase 3 pivotal studies (ARCADIA-1 and ARCADIA-2) in patients with moderate-to-severe atopic dermatitis

JSJonathan I. SilverbergUniversity of Vermont AWAndreas WollenbergVrije Universiteit Brussel FLFranz J. LegatMedical University of Graz

Key Points

At week 48, significant maintenance of IGA success was seen in 61.5% of patients on nemolizumab Q4W, compared to 49.7% on placebo.
Response rates include EASI-75 maintenance in 76.3% of Q4W patients, demonstrating effective long-term management of atopic dermatitis.
Pooled analysis from two double-blind, placebo-controlled phase 3 trials assessed safety and efficacy in moderate-to-severe atopic dermatitis patients over 32 weeks after initial treatment results at week 16 revealed high responder rates and continued improvement with nemolizumab treatment across key measures.

Abstract

Abstract Background Atopic dermatitis (AD) is a common, chronic, and flaring itchy inflammatory skin disease requiring long-term treatment. Nemolizumab significantly improved skin lesions, itch, and sleep through Week (W) 16 in two global phase 3 studies (ARCADIA-1 NCT03985943 and ARCADIA-2 NCT03989349) in adolescents and adults with moderate-to-severe AD.1 Introduction/Background To evaluate the efficacy and the safety of maintenance treatment with nemolizumab with background topical therapy for up to 32 weeks in patients (≥12 years) with moderate-to-severe atopic dermatitis Methods This analysis pooled 32-week maintenance data from two double-blind, placebo controlled, phase 3 studies (N=507) in moderate-to-severe AD. Clinical responders (IGA 0/1 clear/almost-clear or EASI-75 75% improvement in EASI score) to nemolizumab at W16 were re-randomized (1:1:1) to receive nemolizumab 30mg every 4 weeks (Q4W), nemolizumab 30mg Q8W, or placebo (nemolizumab withdrawal) Q4W subcutaneously for further 32 weeks in combination with topical corticosteroids of low/medium potency and/or topical calcineurin inhibitors. Safety was assessed throughout the study. Results At W48, the proportion of patients who maintained IGA success (defined as IGA score of 0 clear or 1 almost clear and a ≥2-point improvement from baseline) was 61.5% (nemolizumab-Q4W), 60.4% (nemolizumab-Q8W), and 49.7% (placebo); EASI-75 was maintained in 76.3% (nemolizumab-Q4W), 75.7% (nemolizumab-Q8W), and 63.9% (placebo); and itch response (≥4 points improvement in weekly average PPNRS) was achieved in 76.2% (nemolizumab-Q4W), 59.7% (nemolizumab-Q8W), and 41.0% (placebo). Similarly, response in sleep and quality of life was well maintained at W48. The safety profile was consistent across treatment arms; most treatment-emergent adverse events were non-serious and mild/moderate in intensity. Conclusions Among patients with clinical responses in skin lesions at W16, the majority maintained skin and itch responses at W48 with nemolizumab Q4W/Q8W. Nemolizumab was well-tolerated up to W48, and no safety signals were identified.

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