Galderma's nemolizumab is showing promise as a long-term therapeutic option for patients with atopic dermatitis and prurigo nodularis, according to new data presented at the 2024 European Academy of Dermatology and Venereology (EADV) congress. The data, from the ARCADIA and OLYMPIA clinical trial programs, highlight the drug's efficacy and safety in treating these chronic skin conditions. Nemolizumab, a targeted inhibitor of IL-31 signaling, addresses key symptoms such as itch and skin inflammation.
ARCADIA Long-Term Extension Study
The ARCADIA long-term extension study evaluated the safety and efficacy of nemolizumab over four years in adolescents and adults with moderate-to-severe atopic dermatitis. Patients enrolled from previous phase II and phase III studies received nemolizumab with background topical corticosteroids, with or without topical calcineurin inhibitors.
Interim results at Week 56 demonstrated that patients previously exposed to nemolizumab in the lead-in study experienced continued improvements in skin lesions compared to when they entered the extension study. Specifically:
- 47% of evaluable patients achieved clear or almost clear skin (IGA score of 0 or 1), up from 29%.
- 73% achieved a 75% improvement in EASI score from their lead-in study baseline, up from 38%.
The data also indicated sustained improvements in itch, sleep, and quality of life, with a consistent safety profile.
Professor Diamant Thaçi, lead investigator of the ARCADIA long-term extension study from the University of Lubeck, Germany, noted, "Many atopic dermatitis patients struggle to achieve holistic symptom relief with currently available treatments, and the few that do continue to seek treatments with longevity. These new data will add to the growing body of evidence demonstrating the potential long-term benefit of nemolizumab in atopic dermatitis, with patients seeing improvements in skin lesions, itch, and quality of life outcomes that continue to increase over time, for more than a year."
Biomarker Analysis from ARCADIA Trials
Additional data from the phase III ARCADIA trials revealed that nemolizumab significantly reduces biomarkers involved in itch, skin lesions, and inflammation. This reduction correlated with improved clinical outcomes, particularly in patients with severe itch, suggesting a greater potential benefit in this subgroup.
OLYMPIA DURABILITY Study
The OLYMPIA DURABILITY study, a 24-week phase IIIb withdrawal study, assessed the long-term efficacy of nemolizumab in adults with prurigo nodularis. The study included 34 patients who had achieved a clinical response in the OLYMPIA long-term extension study, defined by an IGA score of 0 or 1 and at least a four-point improvement in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score from baseline at Week 52.
The study met its primary endpoint, demonstrating that patients continuing nemolizumab therapy had significantly lower relapse rates (17%) compared to those withdrawn from treatment (75%) after 24 weeks. Relapse was defined as at least a four-point increase in PP-NRS score and/or at least a two-point increase in IGA score from baseline. These findings support the continued use of nemolizumab beyond 52 weeks for patients who are clinical responders.
Professor Franz Legat, lead investigator of the OLYMPIA studies from the Medical University of Graz, Austria, stated, "People living with prurigo nodularis suffer from chronic, severe itch, which disrupts their quality of life, and visible skin lesions, which can impact their self-confidence. These new long-term data demonstrate that nemolizumab’s efficacy on itch and skin lesions in prurigo nodularis is maintained for over one year, and also show that continuous treatment is necessary to ensure that these burdensome symptoms remain controlled."
Regulatory Status and Future Directions
Nemolizumab is currently approved in the United States (under the name Nemluvio) for the treatment of adults with prurigo nodularis. The FDA's decision on its use for atopic dermatitis is expected later this year. Galderma has also submitted marketing authorization applications for both prurigo nodularis and atopic dermatitis to multiple regulatory authorities worldwide.
