Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. Issue 3 (May 2021)

• Record Type: Journal Article
• Authors: Marignier, Romain; Bennett, Jeffrey L.; Kim, Ho Jin; Weinshenker, Brian G.; Pittock, Sean J.; Wingerchuk, Dean; Fujihara, Kazuko; Paul, Friedemann; Cutter, Gary R.; Green, Ari J.; Aktas, Orhan; Hartung, Hans-Peter; Lublin, Fred D.; Williams, Ian M.; Drappa, Jorn; She, Dewei; Cimbora, Daniel; Rees, William; Smith, Michael; Ratchford, John N.; Katz, Eliezer; Cree, Bruce A.C.
• Is Part Of: Neurology. Volume 8:Issue 3(2021)
• Publication Date: 2021-05
• Subjects: Neuroimmunology -- Periodicals; Neurology -- Periodicals; 616.8
• DOI: 10.1212/NXI.0000000000000978
• Languages: English
• ISSNs: 2332-7812

Abstract

Abstract : Objective: To assess treatment effects on Expanded Disability Status Scale (EDSS) score worsening and modified Rankin Scale (mRS) scores in the N-MOmentum trial of inebilizumab, a humanized anti-CD19 monoclonal antibody, in participants with neuromyelitis optica spectrum disorder (NMOSD). Methods: Adults (N = 230) with aquaporin-4 immunoglobulin G-seropositive NMOSD or -seronegative neuromyelitis optica and an EDSS score ⩽8 were randomized (3:1) to receive inebilizumab 300 mg or placebo on days 1 and 15. The randomized controlled period (RCP) was 28 weeks or until adjudicated attack, with an option to enter the inebilizumab open-label period. Three-month EDSS-confirmed disability progression (CDP) was assessed using a Cox proportional hazard model. The effect of baseline subgroups on disability was assessed by interaction tests. mRS scores from the RCP were analyzed by the Wilcoxon-Mann-Whitney odds approach. Results: Compared with placebo, inebilizumab reduced the risk of 3-month CDP (hazard ratio [HR]: 0.375; 95% CI: 0.148–0.952; p = 0.0390). Baseline disability, prestudy attack frequency, and disease duration did not affect the treatment effect observed with inebilizumab (HRs: 0.213–0.503; interaction tests: all p > 0.05, indicating no effect of baseline covariates on outcome). Mean EDSS scores improved with longer-term treatment. Inebilizumab-treated participants were more likely to have a favorable mRS outcome at the end of the RCP (OR: 1.663; 95% CI: 1.195–2.385; p = 0.0023). Conclusions: Disability outcomes were more favorable with inebilizumab vs placebo in participants with NMOSD. Classification of Evidence: This study provides Class II evidence that for patients with NMOSD, inebilizumab reduces the risk of worsening disability. N-MOmentum is registered at ClinicalTrials.gov: NCT02200770.