Treatment of neuromyelitis optica with rituximab: a 2-year prospective multicenter study
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Neuromyelitis optica (NMO) is a very severe autoimmune disorder of the central nervous system. It affects young subjects and has a poor prognosis both on a functional and vital level. Therefore, it is imperative to reduce the frequency of relapses. The purpose of this study was to evaluate the clinical and neuroradiological effectiveness of rituximab (RTX) on active forms of NMO.
We conducted a 2-year open prospective multicenter study that included 32 patients treated with RTX at a dose of 375 mg/m2/week for 1 month. When the number of circulating CD19+ B cells reached 1%, a maintenance therapy was started, consisting of two infusions of 1 g of RTX, administered at a 15-day interval. The primary objective was to reduce the annual relapse rate (ARR), in comparison to that observed in the 2 years before treatment onset.
Rituximab administration reduced the ARR from 1.34 to 0.56 (p = 0.0005). The average Expanded Disability Status Scale (EDSS) score significantly improved by 1.1 point, from 5.9 (2–9) to 4.8 (0–9) after 2 years (p = 0.03). Anti-aquaporin-4 antibodies’ level predicted treatment failure (p = 0.03). Frequency of Gad+ lesions in spinal cord decreased from 23.3 to 14.2%. RTX treatment did not prevent the death of three patients (treatment failure in two patients and acute myeloid leukemia in a patient previously treated with mitoxantrone).
Rituximab is clinically effective in active forms of NMO, although few patients are resistant to the treatment.
KeywordsNeuromyelitis optica Rituximab Treatment Magnetic resonance imaging
The authors acknowledge D. Laplaud MD, PhD from CHRU Nantes (France), R. Deschamps MD and O. Gout MD from Rothschild Foundation (France), and J. de Seze MD, PhD, from CHRU Strasbourg (France) for participating in the study. This work has been done using data from The Observatoire Français de la Sclérose en Plaques (OFSEP) which is supported by a grant provided by the French State and handled by the “Agence Nationale de la Recherche”, within the framework of the “Investments for the Future” programme under the reference ANR-10-COHO-002 Observatoire Français de la Sclérose en Plaques (OFSEP), and by the Eugene Devic Foundation against Multiple Sclerosis (EDMUS Foundation).
Compliance with ethical standards
Conflicts of interest
I (Philippe Cabre) assume that none of the authors had a conflict of interest with the content of the present study.
The ethics committee of Fort de France approved this study. All samples were stored at −80 °C at CERBIM (CHU Martinique) that has been labelled by French Ministry of Health.