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SHR Neuro Cancer Cardio Lipid Metab Microb
Kwatra, SG; Yosipovitch, G; Legat, FJ; Reich, A; Paul, C; Simon, D; Naldi, L; Lynde, C; De, Bruin-Weller, MS; Nahm, WK; Sauder, M; Gharib, R; Barbarot, S; Szepietowski, JC; Conrad, C; Fleischer, A; Laquer, VT; Misery, L; Serra-Baldrich, E; Lapeere, H; Ahmad, F; Jabbar, Lopez, ZK; Piketty, C; Ständer, S, , OLYMPIA, 2, Investigators.
Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.
N Engl J Med. 2023; 389(17): 1579-1589.
Doi: 10.1056/NEJMoa2301333
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Legat Franz
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- Abstract:
- BACKGROUND: Prurigo nodularis is a chronic, debilitating, and severely pruritic neuroimmunologic skin disease. Nemolizumab, an interleukin-31 receptor alpha antagonist, down-regulates key pathways in the pathogenesis of prurigo nodularis. METHODS: In this phase 3, double-blind, multicenter, randomized trial, we assigned adults with moderate-to-severe prurigo nodularis to receive an initial 60-mg dose of nemolizumab followed by subcutaneous injections of 30 mg or 60 mg (depending on baseline weight) every 4 weeks for 16 weeks or matching placebo. The primary end points were an itch response (a reduction of ≥4 points on the Peak Pruritus Numerical Rating Scale [PP-NRS; scores range from 0 to 10, with higher scores indicating more severe itch]) and an Investigator's Global Assessment (IGA) response (a score of 0 [clear] or 1 [almost clear] on the IGA [scores range from 0 to 4] and a reduction from baseline to week 16 of ≥2 points). There were five key secondary end points. RESULTS: A total of 274 patients underwent randomization; 183 were assigned to the nemolizumab group, and 91 to the placebo group. Treatment efficacy was shown with respect to both primary end points at week 16; a greater percentage of patients in the nemolizumab group than in the placebo group had an itch response (56.3% vs. 20.9%; strata-adjusted difference, 37.4 percentage points; 95% confidence interval [CI], 26.3 to 48.5), and a greater percentage in the nemolizumab group had an IGA response (37.7% vs. 11.0%; strata-adjusted difference, 28.5 percentage points; 95% CI, 18.8 to 38.2) (P<0.001 for both comparisons). Benefits were observed for the five key secondary end points: itch response at week 4 (41.0% vs. 7.7%), PP-NRS score of less than 2 at week 4 (19.7% vs. 2.2%) and week 16 (35.0% vs. 7.7%), and an improvement of 4 or more points on the sleep disturbance numerical rating scale (range, 0 [no sleep loss] to 10 [unable to sleep at all]) at week 4 (37.2% vs. 9.9%) and week 16 (51.9% vs. 20.9%) (P<0.001 for all comparisons). The most common individual adverse events were headache (6.6% vs. 4.4%) and atopic dermatitis (5.5% vs. 0%). CONCLUSIONS: Nemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT04501679; EudraCT number, 2019-004789-17.).
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Humans - administration & dosage
- Dermatitis, Atopic - chemically induced, etiology
- Double-Blind Method - administration & dosage
- Prurigo - drug therapy, complications
- Pruritus - drug therapy, etiology
- Severity of Illness Index - administration & dosage
- Treatment Outcome - administration & dosage
- Receptors, Interleukin - antagonists & inhibitors
- Antibodies, Monoclonal, Humanized - administration & dosage, adverse effects, therapeutic use