Trial reportAnnals of the rheumatic diseases2013
Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients.
Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 147 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
147 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Infusion-Related Reactions from Immune Checkpoint Inhibitors in Solid Tumors: A Proportional and Network Meta-Analysis.Targeted oncology · 2026Pooled it
- The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review.Drug safety · 2018Pooled it
- Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancies across the rheumatoid arthritis clinical development programme.Annals of the rheumatic diseases · 2016Pooled it
- Mesenchymal stem cells combined with IFN-γ treatment versus mesenchymal stem cells monotherapy: safety and efficacy over five years extension follow-up.Stem cell research & therapy · 2025Trial
- Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.Annals of the rheumatic diseases · 2023Trial
- Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.Rheumatology (Oxford, England) · 2019Trial
- Ultra-low dose of rituximab in rheumatoid arthritis: study protocol for a randomised controlled trial.Trials · 2017Trial
- Leflunomide is equally efficacious and safe compared to low dose rituximab in refractory rheumatoid arthritis given in combination with methotrexate: results from a randomized double blind controlled clinical trial.BMC musculoskeletal disorders · 2017Trial
- Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study.Arthritis research & therapy · 2016Trial
- Trial
- Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial.Arthritis research & therapy · 2015Trial
- Efficacy of B-cell targeted therapy with rituximab in patients with active moderate to severe Graves' orbitopathy: a randomized controlled study.The Journal of clinical endocrinology and metabolism · 2015Trial
- Rituximab therapy for refractory orbital inflammation: results of a phase 1/2, dose-ranging, randomized clinical trial.JAMA ophthalmology · 2014Trial
- Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients.Arthritis research & therapy · 2014Trial
- Proliferative glomerulonephritis with monoclonal IgG3 deposits: A case series.Journal of translational autoimmunity · 2026Article
- Immune context and treatment timing associated with seizure freedom after rituximab in autoimmune limbic encephalitis.iScience · 2026Article
- Rituximab-associated colitis with colonic perforation requiring subtotal colectomy in systemic sclerosis.Clinical journal of gastroenterology · 2026Article
- Case-Based Immunology: B Cells and Systemic Sclerosis Interstitial Lung Disease.Arthritis & rheumatology (Hoboken, N.J.) · 2026Review
- Heart Failure in Rheumatoid Arthritis: Epidemiology, Pathogenesis, Diagnosis, Treatment, and Emerging Insights-A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2026Review
- Effectiveness of Rituximab in rElapsiNg Multiple SclErosis previously treated with hiGhly-Active Disease modifying thErapies (RENEGADE study).Journal of neurology · 2025Observational
87 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesEvaluation of long-term safety of rituximab in rheumatoid arthritis (RA).
methodsPooled observed case analysis of data from patients with moderate-to-severe, active RA treated with rituximab in a global clinical trial programme.
resultsAs of September 2010, 3194 patients had received up to 17 rituximab courses over 9.5 years (11 962 patient-years). Of these, 627 had >5 years' follow-up (4418 patient-years). A pooled placebo population (n=818) (placebo+methotrexate (MTX)) was also analysed. Serious adverse event and infection rates generally remained stable over time and multiple courses. The overall serious infection event (SIE) rate was 3.94/100 patient-years (3.26/100 patient-years in patients observed for >5 years) and was comparable with placebo+MTX (3.79/100 patient-years). Serious opportunistic infections were rare. Overall, 22.4% (n=717) of rituximab-treated patients developed low immunoglobulin (Ig)M and 3.5% (n=112) low IgG levels for ≥4 months after ≥1 course. SIE rates were similar before and during/after development of low Ig levels; however, in patients with low IgG, rates were higher than in patients who never developed low IgG. Rates of myocardial infarction and stroke were consistent with rates in the general RA population. No increased risk of malignancy over time was observed.
conclusionsThis analysis demonstrates that rituximab remains generally well tolerated over time and multiple courses, with a safety profile consistent with published data and clinical trial experience. Overall, the findings indicate that there was no evidence of an increased safety risk or increased reporting rates of any types of adverse events with prolonged exposure to rituximab during the 9.5 years of observation.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.