Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD

In the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo. To demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses. N-MOmentum is a prospecti...

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Bibliographic Details
Published in:Multiple sclerosis Vol. 27; no. 13; p. 2052
Main Authors: Cree, Bruce Ac, Bennett, Jeffrey L, Kim, Ho Jin, Weinshenker, Brian G, Pittock, Sean J, Wingerchuk, Dean, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary R, Marignier, Romain, Green, Ari J, Aktas, Orhan, Hartung, Hans-Peter, Williams, Ian M, Drappa, Jorn, She, Dewei, Cimbora, Daniel, Rees, William, Ratchford, John N, Katz, Eliezer
Format: Journal Article
Language:English
Published: England 01.11.2021
Subjects:
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Aquaporin 4
Humans
Neuromyelitis Optica - drug therapy
Prospective Studies
clinical trial
patient demographics
Attack risk
neuromyelitis optica spectrum disorder
neuromyelitis optica
sensitivity analyses
Devic’s disease
inebilizumab
ISSN:1477-0970, 1477-0970
Online Access:Get more information
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Summary:In the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo. To demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses. N-MOmentum is a prospective, randomized, placebo-controlled, double-masked trial of inebilizumab, an anti-CD19 monoclonal B-cell-depleting antibody, in patients with NMOSD. Pre-planned and analyses were performed to evaluate the primary endpoint across a range of attack definitions and demographic groups, as well as key secondary endpoints. In the N-MOmentum trial (ClinicalTrials.gov: NCT02200770), 174 participants received inebilizumab and 56 received placebo. Attack risk for inebilizumab versus placebo was consistently and significantly reduced, regardless of attack definition, type of attack, baseline disability, ethnicity, treatment history, or disease course (all with hazard ratios < 0.4 favoring inebilizumab, < 0.05). Analyses of secondary endpoints showed similar trends. N-MOmentum demonstrated that inebilizumab provides a robust reduction in the risk of NMOSD attacks regardless of attack evaluation method, attack type, patient demographics, or previous therapy.The N-MOmentum study is registered at ClinicalTrials.gov: NCT2200770.
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ISSN:1477-0970
1477-0970
DOI:10.1177/1352458521988926