A Real-World Study of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder
Mengcui Gui1, Jiayang Zhan1, Jing Lin1, Yue Li1, Bitao Bu1
1Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Hubei Key Laboratory of Neural Injury and Functional Reconstruction, Huazhong University of Science and Technology
Objective:

This study aims to evaluate the efficacy and safety of inebilizumab in Chinese patients with aquaporin-4 immunoglobulin G (AQP4-IgG) positive neuromylitis optic spectrum disorders (NMOSD) in a real-world setting.

Background:

Inebilizumab, a humanized anti-CD19 B cell-depleting monoclonal antibody, has received approval for the treatment of adult NMOSD patients with AQP4-IgG-positive, following the positive results of a phase 2/3 trial (NCT02200770). However, there is a persistent need to explore the real-world management of NMOSD.

Design/Methods:
We conducted a study involving AQP4-IgG-seropositive NMOSD patients who were administered inebilizumab intravenously (300mg on day 1, day 15, and every 6 months) between March 2023 and September 2024. All the patients were followed-up more than 6 months. We analyzed the time to NMOSD attack and the dynamic changes in the expanded disability status scale (EDSS) score, serum AQP4-IgG titters and CD19+ B lymphocyte counts. Adverse reactions were also recorded.
Results:

A total of 45 AQP4-IgG-seropositive NMOSD patients were enrolled, with an average age of 44.8±14.1 years. The mean follow-up duration after initiating inebilizumab treatment was 10.5±3.8 months. At 6-month follow up, no relapses were reported. The EDSS score decreased from a median of 2.75 (range 1.5 to 8.5) to 2.0 (range 1.0 to 7.5), and a more than twofold decrease in AQP4-IgG titters (p<0.01, p<0.05, respectively). The CD19+ B lymphocyte counts also significantly decreased from 418.2±306.6/μl to 5.4±12.0/μl (p<0.01). Among 153 intravenous injections, only one patient reported an allergic reaction, which resolved after discontinuation of the treatment. No severe infections were reported, although there was a slightly decrease in serum levels of IgG, IgM and IgA.

Conclusions:

Inebilizumab significantly reduced attacks, the EDSS score and serum AQP4-IgG titter in AQP4-IgG-positive NMOSD patients, without any serious adverse reaction reported, indicating that it is an effective and safe therapeutic option for NMOSD patients in the real-world.

10.1212/WNL.0000000000210762
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