Nemolizumab’s Long-Term Data Reinforce Efficacy, Tolerability in Prurigo Nodularis

Nemolizumab significantly and safely improved itch and skin lesions for up to 2 years in patients with moderate to severe prurigo nodularis. | Image Credit: this_baker - stock.adobe.com

Nemolizumab (Nemluvio; Galderma) consistently delivers significant and well-tolerated relief from itch and skin lesions for up to 2 years, offering a therapeutic option for patients battling this chronic neuroimmune skin disease, according to new data from the XIV International Congress of Dermatology.¹

Prurigo nodularis is a chronic and distinct neuroimmune skin disease that features intense itch and thick skin nodules, which substantially impact patients’ quality of life. The FDA approved nemolizumab as a prefilled pen for subcutaneous injection to treat adult patients with prurigo nodularis every 4 weeks, almost a year ago.²

Nemolizumab is the first and only biologic approved for both prurigo nodularis and atopic dermatitis, with 4-week dosing intervals from the start of treatment.¹ Additionally, nemolizumab is the first approved monoclonal antibody that specifically targets the interleukin (IL)-31 receptor-α, inhibiting IL-31 signaling.

“As this treatment becomes available in more countries around the world, it’s highly encouraging to see its robust evidence base continue to expand and strengthen,” Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, stated in a news release.

Original results from the phase 3 OLYMPIA 1 (NCT04501679) and 2 (NCT04501666) trials demonstrated the safety and efficacy of nemolizumab administered subcutaneously every 4 weeks in 560 patients with prurigo nodularis.² The OLYMPIA long-term extension study (NCT04204616) assessed the safety and efficacy of nemolizumab in patients with prurigo nodularis for up to 4 years and included 508 patients from the phase 2 trial or the phase 3 OLYMPIA 1 and 2 trials.¹ Results showed that nemolizumab led to sustained and clinically meaningful improvements in prurigo nodularis symptoms during prolonged treatment for up to 2 years.

By week 100, over 90% and 70% of patients achieved at least a 4-point improvement in itch and were itch free or nearly itch free, respectively, as the Peak-Pruritus Numerical Rating Scale measured. Additionally, at least 80% of patients achieved 76% to 100% healed pruriginous lesions. Approximately 75% of patients also reached clearance or almost clearance of skin nodules when researchers assessed their condition using the Investigator’s Global Assessment score. Nemolizumab was well tolerated in the long-term treatment of prurigo nodularis, and this study identified no new safety signals.

These results follow data from the ARCADIA (NCT03989206) long-term extension study. Researchers presented this data at the Revolutionizing Atopic Dermatitis Conference earlier this month, and it showed that nemolizumab treatment was well tolerated and provided sustained and increased improvements in atopic dermatitis symptoms during prolonged treatment up to 2 years.³

“These impressive results give us even more confidence in the value of nemolizumab—a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape,” professor Sonja Stander, lead investigator of the OLYMPIA studies in University Hospital Munster, Germany, stated in a news release.¹

References

1. ICD 2025: new data demonstrate Nemluvio’s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years. Galderma. News release; June 18, 2025. Accessed June 19, 2025. https://www.galderma.com/news/icd-2025-new-data-nemluvio-prurigo-nodularis
2. McCormick B. FDA approves nemolizumab for adult patients with prurigo nodularis. The American Journal of Managed Care^®. August 13, 2024. Accessed June 19, 2025. https://www.ajmc.com/view/fda-approves-nemolizumab-for-adult-patients-with-prurigo-nodularis
3. Long-term data on Nemluvio (nemolizumab) demonstrate its favorable safety profile and sustained and increased improvements in itch and skin lesions in patients with atopic dermatitis up to two years. Galderma. News release; June 6, 2025. Accessed June 19, 2025. https://www.galderma.com/news/rad-2025-nemluvio