Nemolizumab (Nemluvio) has shown sustained improvements in the signs and symptoms of atopic dermatitis (AD) patients over a 56-week period, according to interim findings from the ARCADIA long-term extension analysis presented at the 2024 European Academy of Dermatology & Venereology Congress. The data indicates clinically meaningful improvements in AD-related skin lesions, with benefits increasing up to week 56.
Diamant Thaçi, MD, lead investigator of the ARCADIA analysis and professor at the University of Lubeck in Germany, noted that nemolizumab is an IL-31 receptor antagonist crucial in type 2 inflammation and itch. "Nemolizumab is a receptor antagonist which binds to IL-31 receptors, which is extremely important in type 2 inflammation," Thaçi said. "It is one of the key cytokines that is important in itch... We are talking more about neuroinflammation."
Efficacy Results
The ARCADIA trial investigators reported that 47% of patients achieved clear or almost clear skin, a notable increase from 29% earlier in the analysis. Furthermore, 73% of subjects experienced a 75% improvement in their Eczema Area and Severity Index (EASI) scores, up from 38%. Thaçi highlighted the significant improvement in higher-level EASI 90 scores, suggesting that nemolizumab could play a valuable role in the long-term management of atopic dermatitis.
Safety Profile
The safety profile of nemolizumab remained consistent throughout the trial program, with no unexpected adverse events reported. "We have seen no surprises, and also in the long-term," Thaçi stated. "Furthermore, in long-term management, we also see a numerical decrease of adverse events. There was no conjunctivitis... There was no risk of infection increase."
Clinical Implications
Nemolizumab is currently approved in Japan for AD-associated itch in patients aged 13 years and older and has recently received FDA approval for prurigo nodularis in adults. While not yet approved in Europe, Thaçi anticipates approval soon and emphasizes the importance of mirroring clinical trial findings in daily practice. He also noted the need for further investigation into neuroinflammation and the role of IL-31 in type 2 inflammation.
Previous Studies
Previous phase 2 trials have demonstrated nemolizumab's efficacy in reducing pruritus and improving EASI scores in adult patients with moderate to severe AD. A phase 3 trial in Japan also showed significant improvements in pruritus VAS scores with nemolizumab treatment. The ARCADIA 1 and ARCADIA 2 Phase 3 trials demonstrated that nemolizumab resulted in significant reductions in pruritus scores as early as Week 1, with 42.7% of nemolizumab-treated patients achieving a ≥4-point reduction in the PP-NRS by Week 16, compared to 17.8% in the placebo group in ARCADIA 1 (adjusted difference 24.9%, p < 0.0001).
