NEMLUVIO Demonstrates Durable Efficacy and Safety in Atopic Dermatitis
Key Takeaways
The ARCADIA study shows nemolizumab maintained high efficacy in atopic dermatitis (AD) through 104 weeks.
More than 85% of patients reached EASI 75 with long-term treatment.
No new safety signals were reported.
New two-year interim data from the ARCADIA long-term extension study of NEMLUVIO (nemolizumab) showed sustained improvements in skin and itch outcomes.
The therapy was approved by the FDA in December 2024 for the treatment of atopic dermatitis (AD), representing first neuroimmune-targeting therapy to inhibit IL-31 signaling. The newly released late-breaking data shared during the Revolutionizing Atopic Dermatitis (RAD) meeting indicated that more than 85% of patients achieved at least a 75% reduction in the Eczema Area and Severity Index (EASI 75) at week 104 while being treated with NEMLUVIO. About 85% of patients reported a four-point or greater reduction in itch severity. Almost 70% achieved itch-free or nearly itch-free status. More than half (60%) of patients reached clear or almost-clear skin by IGA criteria. Among treatment naive participants at study entry, 49% achieved EASI 75 and 69% achieved a four-point itch reduction within four weeks. The therapy was well tolerated through two year. There were no new safety signals.
“This new long-term data reinforce nemolizumab’s sustained impact on both itch and skin clearance in patients with moderate to severe atopic dermatitis,” Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology and Director of Clinical Research at The George Washington University School of Medicine and Health Sciences, told Practical Dermatology. “For dermatologists, this offers meaningful evidence of a targeted therapy that can provide consistent, durable relief—which is essential for improving everyday patient quality of life.”
Source: Galderma press statement. June 6, 2025.