Long-Term Tolerability, Safety and Efficacy of Rituximab in Neuromyelitis Optica Spectrum Disorder: A Prospective Study Publisher Pubmed



Shaygannejad V^{1, 2} ; Fayyazi E^{1, 3} ; Badihian S⁴ ; Mirmosayyeb O^{1, 3} ; Manouchehri N⁵ ; Ashtari F^{1, 2} ; Asgari N⁶ Show Affiliations
Source: Journal of Neurology Published:2019

Abstract

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a B-cell-mediated disease with autoimmunity towards the astrocyte water channel aquaporin-4 (AQP-4) in the central nervous system. Objective: To assess the long-term safety and efficacy in NMOSD patients receiving maintenance therapy with B-cell-depleting agent rituximab for more than 2 years. Method: NMOSD patients were included prospectively from 2014 to 2018 and received continuous cycles of rituximab infusions biannually. Incidence of adverse events (AE), serious AEs (SAE), and infusion-related AEs were evaluated through monthly phone calls and neurological examination every 4 months. Results: A total of 44 NMOSD patients were included, of those 30 were treatment naive (68%). The mean age was 37.2 years with 79.5% females. With overall observation period of 31.6 ± 7.3 months (24–48 months), tolerability was assessed as satisfactory in most cases. We observed infusion reactions (mostly mild) in 31.8% of patients and 31.8% never experienced any AEs after a mean 5.1 cycles of rituximab therapy. Rituximab was also beneficial in terms of improvement in relapse rate (from 0.26 ± 0.54 to 0, P = 0.003) and Expanded Disability Status Scale (from 4.1 ± 1.8 to 3.1 ± 1.8, P < 0.001). Stratification according to AQP4-IgG serostatus showed no difference between groups. Conclusion: Rituximab treatment is well tolerated, safe, and efficacious with a minor risk of mild infusion reactions for NMOSD patients. © 2019, Springer-Verlag GmbH Germany, part of Springer Nature.