Late Breaking Data: Long-Term Safety and Efficacy of Nemolizumab for AD

Image Credit: © dermnetnz.org

At last weekend’s Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, Galderma shared late-breaking results from a long-term extension study of nemolizumab (Nemluvio).¹ Patients with atopic dermatitis (AD) sustained clear or almost clear skin up to 104 weeks after initiating treatment. Nemolizumab was approved by the US Food and Drug Administration in December 2024 for the treatment of moderate to severe AD, specifically in patients with a history of inadequate response to topical therapies.²

ARCADIA LTE (NCT03989206) was a prospective, multicenter, open-label study involving 1901 patients ≥12 years old with moderate-to-severe AD. Along with newly recruited adolescents, participants from the 7 phase 2 and 3 lead-in studies below were included.

• Phase 2 adolescent pharmacokinetic/safety study (n=10)
• Phase 2 drug-drug interaction study (n=1)
• Phase 2b dose-ranging study (n=17)
• Phase 2 vaccination safety study (n=149)
• ARCADIA 1 study (n=781)
• ARCADIA 2 study (n=654)
• Phase 3b study (n=254)

These patients were then separated into 2 cohorts; those who were naïve to nemolizumab (n=737) and those who had previous experience with the drug (n=1164). Patients received nemolizumab 30 mg subcutaneously every 4 weeks along with topical calcineurin inhibitors and topical corticosteroids of low to medium potency, if needed. Treatment lasted up to 200 weeks, with an 8-week follow-up.

At baseline, the group that was naïve to nemolizumab had a mean age of 33.3. About 52% were male and nearly 80% were White. The average Eczema Area and Severity Index (EASI) score was 15.6, while the average Scoring Atopic Dermatitis (SCORAD) score was 44.1. Most patients in this group (46.1%) had an Investigator’s Global Assessment (IGA) score of moderate. Additionally, the mean Dermatology Life Quality Index (DLQI) score was 9.3 in adults and 9.0 in children.

Conversely, the nemolizumab-previously experienced group had a mean age of 34.4. Nearly 50% were male and 80.9% were white. The average EASI and SCORAD scores were 11.9 and 35.3, respectively. Similar to the nemolizumab-naïve cohort, most participants had an IGA score of moderate (36.6%). The mean DLQI scores were 6.8 in adults and 5.4 in children.

After 104 weeks, 62.6% of those who had previously used nemolizumab had a sustained IGA 0/1, and 88.2% had an EASI-75 response. To compare, 58.2% reached IGA 0/1 and 85.4% reached EASI-75 in the nemolizumab-naïve group. Similar patterns were observed in those who reached EASI-50 (97.3% in nemolizumab-naïve, 96.3% in nemolizumab-previously experienced) and EASI-90 (63.8% in nemolizumab-naïve, 67.9% in nemolizumab-previously experienced).

In those who were new to nemolizumab, 82.0% observed a ≥4-point improvement in SCORAD VAS Pruritus and 68.9% experienced a ≥4-point improvement in SCORAD VAS Sleep loss. For those who had previously taken nemolizumab, 87.2% saw these same changes in pruritus, while 70.8% saw those improvements in sleep. Approximately 69.6% in the nemolizumab-previously experienced group and 67.2% in the nemolizumab-naïve group were itch-free or nearly itch-free by the end of the trial.

Over 90% of patients in both cohorts experienced clinically meaningful improvements in quality of life with a ≥4-point reduction in DLQI. More specifically, 57.7% of nemolizumab-naïve patients and 55.7% of nemolizumab-previously experienced patients had a DLQI of 0/1. Treatment-emergent adverse events were minor and aligned with the existing safety profile demonstrated in the past phase 3 pivotal trials.

Overall, the ARCADIA program, including this long-term extension study, successfully established the safety and efficacy of nemolizumab, especially when combined with topical calcineurin inhibitors and topical corticosteroids. Over 55% of patients in both groups achieved clear or almost clear skin, with a majority reaching EASI-75. It is also worth noting that the response to treatment in the nemolizumab-naïve patients converged to that in nemolizumab- previously experienced patients.

“The ARCADIA studies showed significance on a number of endpoints: rapid onset of efficacy, particularly with respect to itch, treatment success with respect to improvements of IGA scores, EASI75 response rates, quality of life, sleep disturbances, and a variety of other endpoints,” Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences and author of the study, saidin a recent interview with Dermatology Times.

References

1. Silverberg J, Laquer V, Stein-Gold L, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, TN.

2. Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 14, 2024. Accessed June 10, 2025. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic