Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum.

ABSTRACT:

Background

The N-MOmentum trial investigated safety and efficacy of inebilizumab in participants with neuromyelitis optica spectrum disorder (NMOSD).

Objective

Evaluate the attack identification process and adjudication committee (AC) performance in N-MOmentum.

Methods

Adults (n = 230) with NMOSD and Expanded Disability Status Scale score ⩽8 were randomized (3:1) to inebilizumab 300 mg or placebo. The randomized controlled period was 28 weeks or until adjudicated attack. Attacks were adjudicated according to 18 predefined criteria. Magnetic resonance imaging (MRI) and biomarker (serum glial fibrillary acidic protein [sGFAP]) analyses were performed.

Results

A total of 64 participant-reported neurological events occurred; 51 (80%) were investigator-determ

SUBMITTER: Weinshenker BG 

PROVIDER: S-EPMC10338695 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature