ArticleRMD open2016
Malignancy rates in patients with rheumatoid arthritis treated with tocilizumab.
Article in RMD open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.
- Comparative efficacy and safety of rituximab, tocilizumab, and teprotumumab in Graves' orbitopathy: a systematic review and meta-analysis.Eye (London, England) · 2025Pooled it
- 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
- Trial
- Efficacy, safety, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab intravenously administered to adults with active rheumatoid arthritis and an inadequate response to methotrexate: a phase 3, randomised study.EULAR rheumatology open · 2026Article
- Article
- Comparison of the PK, PD, safety, tolerability, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab in healthy Japanese males: a phase 1, randomised, crossover study.EULAR rheumatology open · 2025Article
- Immunosuppressants/Immunomodulators and Malignancy.Journal of clinical medicine · 2025Review
- Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data.Rheumatology and therapy · 2024Article
- Safety of Immunomodulatory Systemic Therapies Used in the Management of Immune-Related Cutaneous Adverse Events.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Article
- A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19.Advances in therapy · 2022Review
- Long-term outcomes in corticosteroid-refractory Graves' orbitopathy treated with tocilizumab.Clinical endocrinology · 2022Observational
- Primary central nervous system malignant lymphoma in a patient with rheumatoid arthritis receiving tocilizumab: illustrative case.Journal of neurosurgery. Case lessons · 2022Article
- Merkel cell carcinoma presenting as a malignant pleural effusion post-COVID-19 hospitalization: A case report and literature review.Diagnostic cytopathology · 2022Article
- Drugs that Might Be Possibly Used for Treatment of COVID-19 Patients.Russian journal of bioorganic chemistry · 2021Article
- Risk of Malignancies in Patients with Rheumatoid Arthritis Treated with Rituximab: Analyses of Global Postmarketing Safety Data and Long-Term Clinical Trial Data.Rheumatology and therapy · 2020Article
- Interleukin-6 inhibition in the management of non-infectious uveitis and beyond.Journal of ophthalmic inflammation and infection · 2019Review
- Tocilizumab in the treatment of rheumatoid arthritis: an evidence-based review and patient selection.Drug design, development and therapy · 2019Review
- A Practical Approach to the Use of Conventional Synthetic, Biologic and Targeted Synthetic Disease Modifying Anti-Rheumatic Drugs for the Treatment of Inflammatory Arthritis in Patients with a History of Malignancy.Current rheumatology reports · 2018Review
- A Review of Recent Advances Using Tocilizumab in the Treatment of Rheumatic Diseases.Rheumatology and therapy · 2018Review
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo analyse malignancy rates in patients with rheumatoid arthritis (RA) treated with tocilizumab.
methodsPatients who received tocilizumab or placebo+methotrexate/disease-modifying antirheumatic drugs in the double-blind phases of 5-phase three trials or who received at least 1 dose of tocilizumab in the long-term extension studies were analysed up to the 2 May 2012 cut-off date. Malignancies were monitored throughout the studies, analysed and adjudicated as malignant by medical review. Risk was compared with that in the general population using standardised incidence ratios (SIRs) based on data from the Surveillance Epidemiology and End Results SEER (US general population) and GLOBOCAN (non-US general population) databases.
resultsIn total, 4009 patients in the tocilizumab all-exposure population were included. Mean treatment duration was 4.0 years (mean 5.1 (range 0.0-6.8); total observation time was 16 120.1 patient-years (PY). The adjudicated malignancy rate (95% CI) was 1.26/100 PY (1.09 to 1.44) and remained constant over time. The SIR (95% CI) for all malignancies combined, excluding non-melanoma skin cancer, was 1.36 (1.01 to 1.80) for US and 1.81 (1.44 to 2.23) for non-US populations, driven primarily by higher rates in lung and bronchus (US/non-US) malignancies and prostate cancer and non-Hodgkin lymphoma (non-US), in contrast to those for the general populations; these higher rates are in line with those expected in patients with RA or in the geographic regions studied.
conclusionsMalignancy rates remained stable with long-term tocilizumab treatment, and malignancy types and rates were consistent with those expected in patients with RA.
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