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

ABSTRACT:

Background

In the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo.

Objective

To demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses.

Methods

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 post hoc analyses were performed to evaluate the primary endpoint across a range of attack definitions and demographic groups, as well as key secondary endpoints.

Results

In the N-MOmentum trial (ClinicalTrials.gov: NCT02200770), 174 participants received inebilizumab an

SUBMITTER: Cree BA 

PROVIDER: S-EPMC8564264 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature