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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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“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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“Rituximab, a chimeric anti-CD20 monoclonal antibody,(1) is a commonly-used off-label therapy for aquaporin-4-positive neuromyelitis optica spectrum disorders (AQP4 IgG positive NMOSD).(2,3) Rituximab is also used off-label in some patients with MS and myelin oligodendrocyte glycoprotein antibody-associated disease (MO…”
BackgroundGawde, S., Siebert, N., Ruprecht, K., Kumar, G., Ko, R. M., Massey, K., Guthridge, J. M., Mao‐Draayer, Y., Schindler, P., Hastermann, M., et al. (2024) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000200268 · Cited by 13
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“There is a common misconception that damage caused during NMOSD relapse is irreversible; however, the improvements in EDSS score seen in our patient are corroborated by the findings of several studies reporting reductions in EDSS scores in response to targeted treatment (23, 24).”
ResultDas, D., Bhattacharjee, H., Rehman, O., Deori, N., Magdalene, D., Bharali, G., Mishra, S., & Godani, K. (2022) · Indian Journal of Ophthalmology · doi:10.4103/ijo.ijo_61_22 · Cited by 11
“Treatment with rituximab has been found to be beneficial and should not be stopped before at least 2 years of therapy.[7,8]”
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Tallantyre, E. C., Robertson, N. P., & Jolles, S. R. A. (2018) · Current Opinion in Allergy and Clinical Immunology · doi:10.1097/aci.0000000000000485 · Cited by 12
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Efficacy and Safety of Rituximab in Central Nervous System Demyelinating Disorders
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“[26,27] A randomized, open‑label trial showed that rituximab was more efficacious than azathioprine in reducing the ARR.”
BackgroundTreatment strategies for neuromyelitis optica
Tsai, R., Huang, T., Lin, K., & Wang, J.-K. (2018) · Tzu Chi Medical Journal · doi:10.4103/tcmj.tcmj_102_18 · Cited by 9
A meta-analysis on efficacy and safety of rituximab for neuromyelitis optica spectrum disorders
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“Damato et al[42] and Mirmosayyeb et al[43] also have published an article titled A systematic review and meta-analysis of Efficacy and Safety of Rituximab Therapy in Neuromyelitis Optica Spectrum Disorders, which showed that RTX therapy reduces the frequency of NMOSD relapses and neurological disability in patients wi…”
BackgroundNeuromyelitis optica spectrum disorders: a review with a focus on children and adolescents
Paolilo, R. B., da Paz, J. A., Apóstolos‐Pereira, S. L., Rimkus, C. D. M., Callegaro, D., & Sato, D. K. (2023) · Arquivos de Neuro-Psiquiatria · doi:10.1055/s-0043-1761432 · Cited by 9
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“(2), but may worsen with some disease modifying therapies”
BackgroundCarlsson, O., Jónsson, D. I., Brundin, L., & Iacobaeus, E. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13020355 · Cited by 8
“Further acquisition of informed consent is thereby waived.”
BackgroundMethodInfluentialXue, B., Li, J., Xie, D., Weng, Y., Zhang, X., Li, X., Xia, J., & Lin, J. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1458556 · Cited by 8
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“The reduction in the mean EDSS scores was statistically significant in all meta-analyses 6,36,37 .”
BackgroundZeng, P., Chen, D., Zhang, R., Jia, D., Jiang, F., Fan, M., & Zhang, C. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.669567 · Cited by 9
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“Safety profile of rituximab in our study was in line with other studies of NMO/NMOSD (38) with no malignancy or progressive multifocal leukoencephalopathy (PML) being identified during the follow-up period.”
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“In 2016, Damato et al (12) published a systematic review on the efficacy and safety of RTX for NMOSD.”
Low-dose rituximab treatment in a patient with anti-neurofascin-155 IgG4 autoimmune nodopathy
Kmezic, I., Press, R., Glenewinkel, H., Doppler, K., & Appeltshauser, L. (2024) · Journal of Neuroimmunology · doi:10.1016/j.jneuroim.2024.578326 · Cited by 7
“…associated with a significant risk for infections due to secondary hypogammaglobulinemia, persistent leukopenia, progressive multifocal leukoencephalopathy, and even lethal outcome has been re-ported (Martín-Aguilar et al., 2021; Appeltshauser et al., 2023; Damato et al., 2016; Emery et al., 2010).”
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A meaningful exploration of ofatumumab in refractory NMOSD: a case report
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Therapeutic Approach to Autoimmune Neurologic Disorders
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Metadata
- 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 › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Clinical 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
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