Long-Term Data Shows Promise for Nemolizumab in PN

Prurigo nodularis (PN) is a chronic, debilitating skin disorder characterized by intensely itchy, firm nodules that can cause significant discomfort, sleep disturbances, and emotional stress. Managing this condition has long posed challenges for clinicians, as existing therapies often provide limited relief or are associated with adverse effects.¹ However, recent findings from the OLYMPIA open-label extension (LTE) study shed new light on the potential of nemolizumab (Nemluvio; Galderma), a monoclonal antibody targeting the IL-31 receptor alpha, in offering sustained disease control for patients with moderate to severe PN.

Background and Study Design

Today, Galderma announced data from the OLYMPIA LTE, which evaluated the long-term safety and efficacy of nemolizumab over a period extending up to 4 years. The study included 508 patients who had participated in prior phase 2 and phase 3 trials (OLYMPIA 1 and 2). This expansive cohort provides a robust dataset for understanding the durability and tolerability of nemolizumab in managing PN, one of the more challenging pruritic dermatoses.

Key Efficacy Outcomes

The interim analysis at week 148 (roughly 3 years) revealed compelling evidence supporting long-term benefits:

• Skin Clearance: Over 70% of evaluable patients achieved a “clear” or “almost clear” status based on the Investigator’s Global Assessment (IGA). Additionally, more than 85% of participants experienced significant healing of skin lesions, with over 75% of the lesions healed according to the prurigo activity score.
• Itch Reduction: Itch severity, a core symptom affecting patients’ quality of life, improved markedly. More than 85% of patients reported a clinically meaningful reduction in itch. About three-quarters reached an itch-free or nearly itch-free state, offering significant symptomatic relief.
• Quality of Life Improvements: Nearly 90% of patients experienced meaningful enhancements in quality of life, as measured by validated scores, with over half achieving scores indicating minimal or no impact of the disease on daily functioning.

“PN is not only intensely itchy, painful and uncomfortable, it can also take a profound toll on sleep, emotional wellbeing, and daily functioning. That’s why achieving sustained, long-term disease control is critical for patients,” said Shawn Kwatra, MD, lead investigator, professor and chair of dermatology at the University of Maryland School of Medicine in Baltimore, and a Dermatology Times editorial advisory board member. “These data show that nemolizumab can make a meaningful difference to people’s lives by improving itch, skin lesions and quality of life up to three years, with a well-tolerated safety profile.”

Safety Profile

Safety data over the course of the study remained consistent with previous findings, showing no new safety signals. Adverse events were in line with what has been observed in other IL-31 targeting therapies, suggesting a well-tolerated profile over the extended treatment period.

Implications for Clinical Practice

These findings underscore the potential of nemolizumab as a long-term management option for patients with refractory PN. Given the persistent and often refractory nature of PN, having an agent that maintains efficacy over several years while demonstrating a favorable safety profile is particularly notable.

Moreover, nemolizumab’s mechanism of action—blocking IL-31 signaling—is of particular interest. IL-31, a cytokine involved in neuroimmune pathways, plays a pivotal role in mediating pruritus. By inhibiting this pathway, nemolizumab directly addresses one of the primary drivers of PN symptoms, possibly explaining its durable efficacy.

Regulatory Status

Nemolizumab has received approval from multiple regulatory agencies around the world, including the US FDA, for treating PN and moderate to severe atopic dermatitis in certain populations. Its approval is grounded in the evidence suggesting the drug’s capacity to significantly improve skin lesions, relieve itch, and enhance quality of life.

Conclusion

The long-term data from the OLYMPIA LTE offers promising evidence that nemolizumab can be a safe, effective, and sustained therapy for patients with PN. As clinicians seek treatments that address both the physical and psychosocial burden of this challenging condition, these findings reinforce nemolizumab’s role in the evolving landscape of dermatologic therapeutics.

Reference

1. Liao V, Cornman HL, Ma E, Kwatra SG. Prurigo nodularis: new insights into pathogenesis and novel therapeutics. Br J Dermatol. 2024;190(6):798-810. doi:10.1093/bjd/ljae052
2. Galderma’s nemluvio® (nemolizumab) demonstrates long-term disease control in prurigo nodularis up to three years. New release. Galderma. Published February 27, 2026. Accessed February 27, 2026. https://www.galderma.com/news/galdermas-nemluvio-demonstrates-long-term-disease-control-prurigo-nodularis