Inebilizumab in AQP4‐Seropositive NMOSD: One‐Year Follow‐Up From a Multicenter, Real‐World Study
TL;DR
Inebilizumab demonstrated real‐world effectiveness and a manageable safety profile in a diverse population of patients with AQP4‐IgG‐seropositive NMOSD, supporting the findings of the pivotal N‐MOmentum trial.
Abstract
ABSTRACT Objective Real‐world evidence on inebilizumab among neuromyelitis optica spectrum disorder (NMOSD) patients is lacking. This study assessed inebilizumab among Chinese patients with aquaporin 4 autoantibody (AQP4‐IgG)‐seropositive NMOSD in a real‐world setting. Methods This multicenter, prospective, observational study enrolled patients with AQP4‐IgG‐seropositive NMOSD who received at least one dose of inebilizumab. The primary outcome was the time to first adjudicated NMOSD attack. Results A total of 143 patients with AQP4‐IgG‐seropositive NMOSD were included. Over a median follow‐up of 12.4 months (range: 0.4–25.4), five patients (3.50%) experienced attacks, with a 1‐year cumulative incidence of 4.54% (95% confidence interval, 1.66–9.70). Annualized attack rate decreased from 1.02 to 0.03 after inebilizumab treatment, and the Expanded Disability Status Scale scores were significantly improved, with a median change of −0.50 (range, −5.0 to 1.5; p < 0.0001; worsening rate, 0.70%) at 1 year. The most common treatment‐emergent adverse events were urinary tract infection (6.29%), and one case of pneumonia (0.70%) was reported as serious adverse event. B‐cell depletion was effectively achieved, with only 1 patient reporting hypogammaglobulinemia. Conclusion Inebilizumab demonstrated real‐world effectiveness and a manageable safety profile in a diverse population of patients with AQP4‐IgG‐seropositive NMOSD, supporting the findings of the pivotal N‐MOmentum trial.