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| Item Type: | Article |
|---|---|
| Title: | Disability outcomes in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder |
| Creators Name: | Marignier, R. and Bennett, J.L. and Kim, H.J. and Weinshenker, B.G. and Pittock, S.J. and Wingerchuk, D. and Fujihara, K. and Paul, F. and Cutter, G.R. and Green, A.J. and Aktas, O. and Hartung, H.P. and Lublin, F.D. and Williams, I.M. and Drappa, J. and She, D. and Cimbora, D. and Rees, W. and Smith, M. and Ratchford, J.N. and Katz, E. and Cree, B.A.C. |
| 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. |
| Keywords: | Humanized Monoclonal Antibodies, Aquaporin 4, Central Nervous System, Disability Evaluation, Disease Progression, Double-Blind Method, Neuromyelitis Optica, Random Allocation, Treatment Outcome |
| Source: | Neurology Neuroimmunology & Neuroinflammation |
| ISSN: | 2332-7812 |
| Publisher: | American Academy of Neurology |
| Volume: | 8 |
| Number: | 3 |
| Page Range: | e978 |
| Date: | May 2021 |
| Official Publication: | https://doi.org/10.1212/NXI.0000000000000978 |
| PubMed: | View item in PubMed |
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