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Randomized Controlled Trial
. 2022 May;28(6):925-932.
doi: 10.1177/13524585211047223. Epub 2021 Oct 1.

Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial

Mary Rensel  1   2 , Aram Zabeti  3 , Maureen A Mealy  4 , Daniel Cimbora  4 , Dewei She  4 , Jorn Drappa  4 , Eliezer Katz  4
Affiliations
Randomized Controlled Trial

Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial

Mary Rensel et al. Mult Scler. 2022 May.

Abstract

Background: Efficacy and safety of inebilizumab for treatment of neuromyelitis optica spectrum disorder in adults seropositive for aquaporin-4 (AQP4)-immunoglobulin (Ig) G were demonstrated in the 28-week randomized controlled period of the N-MOmentum study.

Objective: To assess efficacy and safety of long-term inebilizumab treatment.

Methods: Post hoc analysis was performed in 75 AQP4-IgG-seropositive participants receiving inebilizumab for ⩾4 years in the randomized controlled period and open-label extension of the N-MOmentum study.

Results: Eighteen attacks occurred in 13 participants during inebilizumab treatment (annualized attack rate, 0.052 attacks/person-year). Twelve attacks occurred during the first year of treatment, and two each occurred in years 2-4. Disability scores remained stable throughout ⩾4 years of treatment. Inebilizumab was well tolerated, with two (2.7%) serious treatment-emergent adverse events related to inebilizumab and no deaths. Immunoglobulin G levels decreased over time; however, correlation between severe infections and low IgG levels could not be determined because of their small numbers.

Conclusion: These results from the N-MOmentum study continue to support use of inebilizumab for treatment of neuromyelitis optica spectrum disorder. Furthermore, the findings suggest that efficacy of inebilizumab may be enhanced after the first year of treatment, warranting additional long-term investigation.

Keywords: Anti-CD19 monoclonal antibody; neuromyelitis optica spectrum disorder; optic neuritis; transverse myelitis.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.R. has received research funding from Genentech, NMSS, Novartis, and PPD; has received patient-education funds from Genzyme; has served on the DSMC for Biogen; has served as a speaker or consultant for Genentech, Improve Consulting, Kijia, MSAA, Novartis, and Serono; and is the owner or co-owner of Brain Fresh and Brain Ops Group. A.Z. has received research funding from Alexion, BEAT-MS (NIH), DELIVER (PICORI), Genentech-Roche, and Novartis; and has served as a speaker or on advisory boards for Alexion, Biogen, Genentech-Roche, Horizon Therapeutics, Novartis, and Sanofi-Genzyme. M.A.M., D.C., D.S., J.D., and E.K. are the employees of Horizon Therapeutics and may hold stock and/or stock options in the company.

Figures

Figure 1.
Figure 1.
Adjudicated attacks in AQP4–IgG–seropositive participants receiving inebilizumab for ⩾4 years. (a) Timeline of adjudicated attacks for AQP4–IgG–seropositive participants with ⩾4 years of inebilizumab treatment. (b) Kaplan–Meier plot of attack-free probability after initiation of inebilizumab. AQP4: aquaporin-4; Ig: immunoglobulin; NMOSD: neuromyelitis optica spectrum disorder; OLE: open-label extension; RCP: randomized controlled period.
Figure 2.
Figure 2.
Median change from baseline in EDSS score by visit and initial randomized treatment group in AQP4–IgG–seropositive participants receiving inebilizumab for ⩾4 years. AQP4: aquaporin-4; EDSS: Expanded Disability Status Scale; Ig: immunoglobulin; OLE: open-label extension; RCP: randomized controlled period. The RCP is indicated in gray. All participants received inebilizumab during the OLE. Bars represent the median absolute deviation.
Figure 3.
Figure 3.
Median IgG titers by visit and initial randomized treatment group in AQP4–IgG–seropositive participants receiving inebilizumab for ⩾4 years. AQP4: aquaporin-4; Ig: immunoglobulin; OLE: open-label extension; RCP: randomized controlled period. The RCP is indicated in gray. All participants received inebilizumab during the OLE. Bars represent the median absolute deviation.
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