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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., Bennett, J.L., Kim, H.J., Weinshenker, B.G., Pittock, S.J., Wingerchuk, D., Fujihara, K., Paul, F., Cutter, G.R., Green, A.J., Aktas, O., Hartung, H.P., Lublin, F.D., Williams, I.M., Drappa, J., She, D., Cimbora, D., Rees, W., Smith, M., Ratchford, J.N., 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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