Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.
Details
Serval ID
serval:BIB_0A637DD42145
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.
Journal
The New England journal of medicine
Working group(s)
OLYMPIA 2 Investigators
Contributor(s)
Ghislain P.D., Hillary T., Nikkels A., Lapeere H., Lynde C.W., Barber K., Sauder M.B., Loo W.J., Niakosari F., Barbarot S., Misery L., Perrot J.L., Tetart F., Passeron T., Paul C., Nosbaum A., Bouaziz J.D., Le Borgne de Lavillandre J., Seneschal J., Chasset F., Son S.W., Park C.W., Ahn H.H., Kim T.G., Ro Y.S., de Bruin-Weller M., Schuttelaar M.L., Narbutt J., Reich A., Kaszuba A., Bystrzanowska D., Rewerska B., Placek W., Kalowska M., Krasowska D., Weglowska J., Walecka-Herniczek I., Debniak T., Szepietowski J., Gebska E., Sulik M., Kardynal A., Zdybski J., Serra Baldrich E., Carretero G., Conrad C., Simon D., Cozzio A., Jalili A., Tyring S.K., Owen C.E., Silverberg J., Dawes K., Abramovits W., Yosipovitch G., Nahm W.K., DeMaria J.J., Laquer V., Rucker R.G., Dimitropoulos V., Sullivan T.P., Carrasco D., Fleishcer A.B., Feser C., Green Knoepp T., Granstein R.D., Bilu-Martin D., Lewitt G.M.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
26/10/2023
Peer-reviewed
Oui
Editor
Ghislain Pd Hillary T. Nikkels A. Lapeere H. Lynde C. W. Barber K. Sauder M. B. Loo W. J. Niakosari F. Barbarot S. Misery L. Perrot J. L. Tetart F. Passeron T. Paul C. Nosbaum A. Bouaziz J. D. Le Borgne de Lavillandre J. Seneschal J. Chasset F. Son S. W. Park C. W. Ahn H. H. Kim T. G. Ro Y. S. de Bruin-Weller M. Schuttelaar M. L. Narbutt J. Reich A. Kaszuba A. Bystrzanowska D. Rewerska B. Placek W. Kalowska M. Krasowska D. Weglowska J. Walecka-Herniczek I. Debniak T. Szepietowski J. Gebska E. Sulik M. Kardynal A. Zdybski J. Serra Baldrich E. Carretero G. Conrad C. Simon D. Cozzio A. Jalili A. Tyring S. K. Owen C. E. Silverberg J. Dawes K. Abramovits W. Yosipovitch G. Nahm W. K. DeMaria J. J. Laquer V. Rucker R. G. Dimitropoulos V. Sullivan T. P. Carrasco D. Fleishcer A. B. Jr Feser C. Green Knoepp T. Granstein R. D. Bilu-Martin D. Lewitt G. M.
Volume
389
Number
17
Pages
1579-1589
Language
english
Notes
Publication types: Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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%).
Nemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT04501679; EudraCT number, 2019-004789-17.).
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.
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%).
Nemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT04501679; EudraCT number, 2019-004789-17.).
Keywords
Adult, Humans, Dermatitis, Atopic/chemically induced, Dermatitis, Atopic/etiology, Double-Blind Method, Prurigo/drug therapy, Prurigo/complications, Pruritus/drug therapy, Pruritus/etiology, Severity of Illness Index, Treatment Outcome, Receptors, Interleukin/antagonists & inhibitors, Antibodies, Monoclonal, Humanized/administration & dosage, Antibodies, Monoclonal, Humanized/adverse effects, Antibodies, Monoclonal, Humanized/therapeutic use
Pubmed
Create date
30/10/2023 13:51
Last modification date
19/12/2023 8:14
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