Nemolizumab Long-Term Safety and Efficacy up to 148 Weeks in the OLYMPIA Open-Label Extension Study in Patients with Prurigo Nodularis
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Keywords
Nemolizumab, Prurigo Nodularis, Chronic prurigo, pruritus, Interleukin-31, long-term extension trial
Abstract
Background Nemolizumab, the first interleukin-31 receptor alpha antagonist approved for prurigo nodularis (PN) in several countries, previously showed sustained clinical benefits for up to 100 weeks.
Objective To assess the long-term cumulative safety and efficacy of nemolizumab, up to 148 weeks, in patients with PN in the ongoing open-label long-term extension study (OLYMPIA-LTE [NCT04204616]).
Methods Adults with moderate-to-severe PN from phase 2/3 lead-in studies entered the ongoing 184-week (W) OLYMPIA-LTE trial. Patients receiving nemolizumab monotherapy during lead-in studies continued their regimen; those on placebo initiated nemolizumab monotherapy. Safety was assessed throughout. Efficacy assessments included proportion of patients achieving Investigator’s Global Assessment (IGA) score 0/1 (clear/almost clear skin), >75% healed pruriginous lesions (Prurigo Activity Score Item-5b [PAS5b]), ≥4-point improvement from lead-in baseline in weekly average Peak Pruritus Numerical Rating Scale (PPNRS4), and no disease impact on quality of life (Dermatology Life Quality Index [DLQI] score 0/1) through W148.
Results At interim Observed Cases analysis data cut-off 21-Jul-2025, 275/508 (54.1%) patients completed W148 (median exposure: 1147.5 days). Treatment-emergent adverse events (TEAEs) occurred in 90.9%; 34.3% were nemolizumab related; 12.8% were severe. Most frequent TEAEs were COVID-19 (28.5%), nasopharyngitis (23.8%), and upper respiratory tract infections (16.1%). Serious TEAEs occurred in 19.7%; 2% were related to nemolizumab. AESIs, mainly infections, were reported in 41.1% of patients. Most events occurred within 12 months and did not increase over time. At W148, of evaluable patients treated with nemolizumab, 74.0% achieved IGA score 0/1; 88.8% PAS5b, 87.4% PPNRS4, and 55.3% DLQI score 0/1.
Conclusion The long-term safety profile of nemolizumab remains consistent with previous findings. Nemolizumab maintained long-term disease control, with clinically meaningful improvements in itch intensity and pruriginous lesions at W148 in evaluable patients, representing the longest LTE study for PN reported to date.
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