Nemolizumab Meets Key Endpoints in ARCADIA Studies

Nemolizumab, a monoclonal antibody targeting the IL-31 receptor, showed efficacy for the treatment of atopic dermatitis, particularly pruritus and sleep disturbance, according to an announcement from Galderma.

The full results of the phase III ARCADIA 1 and 2 trials for nemolizumab were published in a recent issue of The Lancet, with Galderma announcing the publication of the data this past week. The trials evaluated nemolizumab in combination with topical corticosteroids (TCS) and, optionally, topical calcineurin inhibitors (TCI), compared to placebo using similar adjunctive treatments. The studies included a combined 1,728 adolescent and adult patients with moderate-to-severe atopic dermatitis.

According to the results, 36% of patients in ARCADIA 1 and 38% of patients in ARCADIA 2 treated with nemolizumab achieved clear or almost-clear skin, compared to 25% and 26% in the placebo group (P < 0.001), respectively. Additionally, 44% and 42% of nemolizumab-treated patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI) score, respectively, compared to 29% and 30% in the placebo group (P < 0.001), respectively. For key secondary endpoints, significant improvements in skin lesions, itch, and sleep disturbance were observed by Week 16, with itch relief noticeable as early as Week 1. 

The safety profile was consistent, and no unexpected adverse events were reported. The FDA has accepted Galderma’s Biologics License Application for nemolizumab, with a decision expected by year's end. 

"The ARCADIA study results are very important because they inform our understanding of how well nemolizumab performs in patients and with moderate-severe atopic dermatitis and support the regulatory approval of nemolizumab in the United States and other global regions," lead investigator Johnathan Silverberg, MD, told Practical Dermatology. "The ARCADIA results show that nemolizumab is highly effective at improving both the signs and symptoms of atopic dermatitis, especially itch and sleep disturbances. Taken together with the outstanding efficacy and safety demonstrated in the OLYMPIA program for prurigo nodularis, I expect nemolizumab to be a wonderful addition to our toolbox for managing atopic dermatitis and many other pruritic others."