Efficacy and Safety of Rituximab Versus Inebilizumab in Patients With Neuromyelitis Optica Spectrum Disorder: A Dual-Center, Real-World Cohort Study.

BACKGROUND

This study aimed to compare the real-world efficacy and safety of rituximab and inebilizumab in patients with aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD).

METHODS

This retrospective study included patients treated with rituximab or inebilizumab at two tertiary hospitals in China between January 2015 and June 2025. Propensity score matching was conducted to reduce between-group imbalance. The primary endpoint was time to first confirmed relapse. Secondary outcomes included changes in annualized relapse frequency, EDSS scores, and serum IgG and AQP4-IgG levels. Safety profiles were also assessed.

RESULTS

A total of 276 patients were analyzed (rituximab: 211; inebilizumab: 65), yielding 61 well-balanced pairs after propensity score matching. In terms of efficacy, clinical outcomes and AQP4-IgG dynamics were comparable between groups in pre- and post-matching analyses, although inebilizumab exhibited a significantly greater reduction in serum IgG levels at 6 months. Safety profiles differed. Rituximab was associated with a higher incidence of overall adverse events, driven primarily by infusion-related reactions, whereas other adverse events remained comparable.

CONCLUSIONS

In our real-world study of 276 patients, rituximab and inebilizumab demonstrated comparable efficacy in the medium term but differed in their safety profiles, with a significantly higher incidence of infusion-related reactions observed in the rituximab group.