Efficacy and Safety of Rituximab Therapy in Neuromyelitis Optica Spectrum Disorders: A Systematic Review and Meta-analysis
Open accessAbstract
IMPORTANCE: Neuromyelitis optica spectrum disorders (NMOSDs) are autoimmune astrocytopathies characterized by predominant involvement of the optic nerves and spinal cord. In most patients, an IgG autoantibody binding to astrocytic aquaporin 4, the principal water channel of the central nervous system, is detected. Rituximab, a chimeric monoclonal antibody specific for the CD20 B-lymphocyte surface antigen, has been increasingly adopted as a first-line off-label treatment for patients with NMOSDs. OBJECTIVE: To perform a systematic review and a meta-analysis of the efficacy and safety of rituximab use in NMOSDs, considering the potential predictive factors related to patient response to rituximab in this disease. EVIDENCE REVIEW: English-language studies published between January 1, 2000, and July 31, 2015, were searched in the MEDLINE, Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov databases. Patient characteristics, outcome measures, treatment regimens, and recorded adverse effects were extracted. FINDINGS: Forty-six studies were included in the systematic review. Twenty-five studies that included 2 or more patients with NMOSDs treated with rituximab were included in the meta-analysis. Differences in the annualized relapse rate ratio and Expanded Disability Status Scale score before and after rituximab therapy were the main efficacy measures. Safety outcomes included the proportion of deaths, withdrawals because of toxic effects, and adverse effects. RESULTS: Among 46 studies involving 438 patients (381 female and 56 male [sex was not specified in 1 patient]; mean age at the outset of treatment, 32 years [age range, 2-77 years]), rituximab therapy resulted in a mean (SE) 0.79 (0.15) (95% CI, -1.08 to -0.49) reduction in the mean annualized relapse rate ratio and a mean (SE) 0.64 (0.27) (95% CI, -1.18 to -0.10) reduction in the mean Expanded Disability Status Scale score. A significant correlation was observed between disease duration and the Expanded Disability Status Scale score. Adverse effects were recorded in 114 of 438 (26%) patients treated with rituximab. Specifically, 45 patients (10.3%) experienced infusion-related adverse effects, 40 patients (9.1%) had an infection, 20 patients (4.6%) developed persistent leukopenia, 2 patients (0.5%) were diagnosed as having posterior reversible encephalopathy, and 7 patients (1.6%) died. CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis provides evidence that rituximab therapy reduces the frequency of NMOSD relapses and neurological disability in patients with NMOSDs. However, the safety profile suggests caution in prescribing rituximab as a first-line therapy.
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The long-term persistence of (re-)activatable autoantigen-specific ThEx cells in patients in remission may well explain the less-than-perfect treatment efficacy of steroid-sparing agents, depletion of CD19/CD20 memory B cells, as well as exacerbation of disease by b-IFN.
“In any case, the long-term persistence of (re-)activatable autoantigen-specific ThEx cells in patients in remission may well explain the less-than-perfect treatment efficacy of steroid-sparing agents, 64-67 depletion of CD19/CD20 memory B cells, 68,69 as well as exacerbation of disease by b -IFN. 27,70”
From Autoantigen-specific CD4+ T cells acquire an exhausted phenotype and persist in human antigen-specific autoimmune diseases (2024) · cites this paper as [69]
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“Off-label use in autoimmune disease includes multiple sclerosis (360, 361), thrombotic thrombocytopenic purpura (362, 363), immune thrombocytopenia (ITP) (364), myasthenia gravis (365), neuromyelitis optica (366), lupus nephritis (367), idiopathic membranous nephropathy (368), autoimmune hemolytic anemia (369), and ch…”
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“[94] Eculizumab is the first monoclonal antibody that has been approved by FDA for use in NMOSD.”
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“2 points.(31) Possibly, even more impressive results could be achieved if all patients are treated to complete suppression of CD191 (<0.”
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“According to statistics, only 20% of patients normally needed hospitalization (Damato et al., 2016), while in case of patients with NMOSD in the current study, this rate was 60%.”
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- Authors
- Damato, V., Evoli, A., & Iorio, R.
- Affiliations
- Agostino Gemelli University Polyclinic (IT)
- Don Carlo Gnocchi Foundation (IT)
- Corresponding author
- Iorio, Raffaele
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2016-11-01
- Volume
- 73
- Issue
- 11
- Pages
- 1342
- ISSN
- 2168-6149 (ISSN-L)
- OpenAlex
- W2524675862
- Cited by
- 290
- References
- 66
- Citations by year
- 2026: 21 · 2025: 26 · 2024: 25 · 2023: 29 · 2022: 34 · 2021: 50 · 2020: 49 · 2019: 24 · 2018: 20 · 2017: 11 · 2016: 1
- FWCI
- 2.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Neurology (publishedVersion)
- PubMed (publishedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Neurology › Peripheral Neuropathies and Disorders
- Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
- Keywords
- neuromyelitis optica spectrum disorder, rituximab, CD20, off-label drug use, aquaporin-4 antibodies, annualized relapse rate, Expanded Disability Status Scale, disability progression, treatment safety, disease duration, predictors of treatment response, autoimmune demyelinating disease, B-cell depletion therapy, relapse prevention
- MeSH terms
- Rituximab, Adolescent, Adult, Aged, Child, Child, Preschool, Female, Humans, Immunologic Factors, Male, Middle Aged, Neuromyelitis Optica, Outcome Assessment, Health Care, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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