Objective:

This study aimed to evaluate the real-world effectiveness and safety of inebilizumab for patients with AQP4-IgG positive neuromyelitis optica spectrum disorders (NMOSD).

Background:

Design/Methods:

We conducted a retrospective analysis of the data from NMOSD patients treated with inebilizumab at a clinical center since 2023. Efficacy of inebilizumab was comprehensively assessed by relapse rate per year, annualized relapse rate (ARR), expanded disability status scale (EDSS) score, number of magnetic resonance imaging (MRI) T2 FLAIR lesions, and B-lymphocyte count. Safety was monitored by tracking laboratory values and adverse events.

Results:

A total of 42 patients were enrolled in the study, with 4 experiencing relapses, corresponding to a relapse rate of 9.52%. After 6 months of therapy, ARR (0.20±0.69) and EDSS score (2.54±1.79) were both significantly improved compared to pre-treatment (0.81±0.68 and 3.00±1.68, respectively; P<0.05). The number of MRI T2 FLAIR lesions (4.95±5.24) was significantly lower than pre-treatment (6.87±5.07; P<0.05). B-lymphocyte counts decreased to less than 1% within the first half month and all remained at ≤4 cells/μl after 6 months of treatment. A total of 23 patients were co-positive with other autoimmune antibodies, of which 5 had antibody seroconversion after 6 months of treatment. The most frequent adverse event in this study was pulmonary infection, which occurred in 3 patients. Other adverse reactions included elevated uric acid levels and hepatic impairment, with no fatalities reported.

Conclusions:

The single-center real-world study suggests that inebilizumab can effectively reduce the ARR, EDSS score, and MRI T2 FLAIR lesions in patients with NMOSD, and has a good safety profile, confirming its application value in the real-world.