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Disability outcomes in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder

Authors

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

Journal

  • Neurology Neuroimmunology & Neuroinflammation

Citation

  • Neurol Neuroimmunol Neuroinflamm 8 (3): e978

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.


DOI

doi:10.1212/NXI.0000000000000978