Nemolizumab improves signs, symptoms of atopic dermatitis up to 56 weeks

Key takeaways:

• More than a quarter of patients achieved IGA clear or almost clear as well as a 2-grade improvement from baseline.
• Adverse events were low across skin types.

New interim, long-term results showed that nemolizumab improved signs and symptoms of atopic dermatitis including sleep, itch and quality of life, according to a presentation at the European Academy of Dermatology and Venereology Congress.

The oral presentation included new 56-week data from an interim analysis of the phase 3 long-term extension trial, ARCADIA, showing that nemolizumab continuously improved atopic dermatitis.

“The results from the interim analysis of the ARCADIA long-term extension study support, for the first time, the long-term use of nemolizumab in managing moderate to severe atopic dermatitis, showing continuous improvements in skin lesions, itch, sleep and quality of life for at least 1 year whilst maintaining a consistent and favorable safety profile,” Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of R&D at Galderma, told Healio.

The long-term trial recruited subjects from the previous ARCADIA 1 and ARCADIA 2 trials. Of the 1,751 patients, 1,740 were treated and 723 completed 56 weeks of treatment.

Among those previously exposed to nemolizumab (n = 962), 47.1% achieved an IGA score of clear or almost clear and 73% reached EASI 75 by week 56. Similarly, 49% of nemolizumab-naïve patients (n = 536) also reached IGA scores of clear or almost clear and 78.7% achieved EASI 75 by the end of the interim analysis.

“I was pleased to see that the ARCADIA long-term extension interim analysis data showed that nemolizumab was equally effective for both patients being treated for the first time and those previously treated with the drug,” Sforzolini said. “It was also particularly encouraging to see that patient responses to treatment increased over time.”

Signs and symptoms of AD also improved with both groups reporting a 75% to 76.1% improvement in itch by week 56 from baseline. These patients also reported a 69.8% to 71.3% improvement in sleep loss and 86% to 90.1% of patients reported a 4-point or more reduction in quality-of-life impairment.

Up to 68.5% of patients experienced an adverse event across the two groups; however, only up to 0.7% were serious treatment-emergent events considered related to the study drug.

“We are very encouraged by these results and remain fully committed to bringing nemolizumab to patients worldwide who are dealing with these challenging skin conditions as soon as possible,” Sforzolini told Healio. “We expect a decision from the U.S. FDA on our biologics license application in atopic dermatitis by the end of the year and we continue to work closely with regulators in Europe, and elsewhere, where our filing applications for nemolizumab in moderate to severe atopic dermatitis and prurigo nodularis are currently under review.”

Reference:

• EADV 2024 Late breaking news sessions: New Galderma data demonstrating nemolizumab’s long-term efficacy and safety in atopic dermatitis and durability in prurigo nodularis to be shared during three oral presentations. https://www.galderma.com/news/eadv-2024-late-breaking-news-sessions-new-galderma-data-demonstrating-nemolizumabs-long-term. Published Sept. 25, 2024. Accessed Sept. 26, 2024.