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Clinical Trial
. 2025 Feb 1;161(2):147-156.
doi: 10.1001/jamadermatol.2024.4796.

Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial

Sonja Ständer  1 , Gil Yosipovitch  2 , Franz J Legat  3 , Adam Reich  4 , Carle Paul  5 , Dagmar Simon  6 , Luigi Naldi  7 , Martin Metz  8 , Athanasios Tsianakas  9 , Andrew Pink  10 , Simon Fage  11 , Giuseppe Micali  12 , Elke Weisshaar  13 , Hema Sundaram  14   15 , Andrei Metelitsa  16 , Matthias Augustin  17 , Andreas Wollenberg  18   19   20 , Bernhard Homey  21 , Maria Concetta Fargnoli  22 , Howard Sofen  23 , Neil J Korman  24 , Lone Skov  25 , Xiaoxiao Chen  26 , Zarif K Jabbar-Lopez  27 , Christophe Piketty  27 , Shawn G Kwatra  28   29 ; OLYMPIA 1 Investigators
Collaborators, Affiliations
Clinical Trial

Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial

Sonja Ständer et al. JAMA Dermatol. .

Abstract

Importance: Prurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2).

Objective: To assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo.

Design, setting, and participants: OLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator's Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods.

Interventions: Patients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks.

Main outcomes and measures: The primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.

Results: Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P < .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.

Conclusions and relevance: In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN.

Trial registration: ClinicalTrials.gov Identifier: NCT04501666.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ständer reported receiving grants, personal fees, and additional compensation from Galderma during the study, along with grants, personal fees, and additional compensation from Sanofi, Incyte, Celldex, and Amgen outside the submitted work. Prof Yosipovitch reported grants and personal fees from Galderma and Regeneron Sanofi, and further support from Pfizer, AbbVie, Eli Lilly, GSK, Novartis, Escient, and Amgen. Dr Legat reported compensation from Galderma and consulting fees or honoraria from AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Galderma, LEO Pharma, Menlo Therapeutics, Novartis, Pelpharma, Pfizer, Sanofi Aventis, Trevi Therapeutics, and Vifor Pharma outside the submitted work, along with consultancy, advisory, or speaking roles for Almirall and Celgene. Dr Reich reported receiving personal fees from Galderma during the study and from Novartis, Sanofi, and Trevi outside the submitted work. Dr Paul reported receiving personal fees from Galderma, AbbVie, Boehringer, BMS, Eli Lilly, Janssen, and Pfizer outside the submitted work. Prof Naldi reported grants from Galderma and additional grants and fees from AbbVie, Almirall, BMS, Galderma, Leo, Eli Lilly, Janssen, Novartis, Pfizer, and Sanofi outside the submitted work. Prof Metz reported personal fees and support from Galderma during the study and advisory board or speaking fees from Amgen, AstraZeneca, argenx, Celldex, Escient, Jasper Therapeutics, Novartis, Pharvaris, Sanofi-Aventis, and Third Harmonic Bio outside the study. Dr Tsianakas reported consulting fees from Galderma outside the study. Dr Pink reported fees and educational support from several companies, including Galderma, Pfizer, and Janssen, outside the study. Dr Sundaram reported grants from Galderma during the study. Prof Augustin reported extensive consulting, speaking, and trial participation roles, supported by several companies in prurigo treatment outside the study. Prof Wollenberg reported participation in trials with Galderma and receiving various forms of support from AbbVie, Aileens, Alentis, Almirall, Amgen, Beiersdorf, Bioderma, Bioproject, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, DKSH, Eli Lilly, Galapagos, Galderma, Glenmark, GSK, Hans Karrer, Hexal, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Maruho, MedImmune, Merck, MSD, Mylan, MSD, Novartis, Pfizer, Pierre Fabre, Regeneron, Sandoz, Santen, Sanofi-Aventis, and UCB outside the study. Dr Homey reported grants and personal fees from Galderma, as well as compensation from AbbVie, Almirall, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, L’Oréal, Maruho, Novartis, Pfizer, Regeneron, and Sanofi outside the submitted work. Prof Fargnoli reported fees from Pfizer, Sanofi, Lilly, and AbbVie and a role as a principal investigator for Galderma, Sanofi, and AbbVie outside the study. Dr Sofen reported grants from Galderma and other companies outside the study. Dr Korman reported personal fees and grants for advisory board and investigator roles from several companies, including Arcutis and Sanofi, outside the study. Prof Skov reported participation and compensation for clinical trials with Galderma, along with grants and personal fees from Amgen, Almirall, AbbVie, Boehringer-Ingelheim, BMS, Galderma, Incyte, LEO Pharma, UCB, Eli Lilly, Pfizer, Janssen, Novartis, Sanofi, Novo Nordisk, Stada, and Takeda outside the study. Dr Jabbar-Lopez reported holding stock in Galderma. No other disclosures were reported.

References

    1. Elmariah S, Kim B, Berger T, et al. . Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. doi:10.1016/j.jaad.2020.07.025 - DOI - PubMed
    1. Pereira MP, Steinke S, Zeidler C, et al. . European academy of dermatology and venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570 - DOI - PubMed
    1. Boozalis E, Tang O, Patel S, et al. . Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79(4):714-719 e3. doi:10.1016/j.jaad.2018.04.047 - DOI - PMC - PubMed
    1. Huang AH, Canner JK, Khanna R, Kang S, Kwatra SG. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483e4. doi:10.1016/j.jid.2019.07.697 - DOI - PubMed
    1. Muller S, Zeidler C, Stander S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2023;25:15-33. doi:10.1007/s40257-023-00818-z - DOI - PMC - PubMed

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