ArticleRheumatology and therapy2016
Incidence of Gastrointestinal Perforations in Patients with Rheumatoid Arthritis Treated with Tocilizumab from Clinical Trial, Postmarketing, and Real-World Data Sources.
Article in Rheumatology and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis 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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Pooled it
- Trial
- Critical Intestinal Perforations in Pediatric Immunocompromised Patients: A Case-Based Review.Pediatric reports · 2026Article
- Article
- Management of chimeric antigen receptor T-cell-related toxicity of a patient affected by cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, followed by an intestinal perforation: a case report.Journal of medical case reports · 2025Article
- Advances in Interleukin-6 Family Cytokines and the Role in Respiratory Diseases.Journal of inflammation research · 2025Review
- Multiple Ulcers with Perforations of the Small Intestine in the Acute Phase of CD19 Chimeric Antigen Receptor T-cell Therapy Possibly Associated with Tocilizumab Administration.Internal medicine (Tokyo, Japan) · 2025Article
- Advancing therapeutic frontiers: a pipeline of novel drugs for luminal and perianal Crohn's disease management.Therapeutic advances in gastroenterology · 2024Review
- Immunotherapies in chronic pain through modulation of neuroimmune interactions.Pharmacology & therapeutics · 2023Review
- A Case of Abdominal Perforation in a COVID+ Patient Treated With Tocilizumab and Corticosteroids.Clinical medicine insights. Case reports · 2023Article
- A Case Report of Bowel Perforation in a Gravid COVID-19 Patient.Case reports in medicine · 2023Article
- Article
- [Intestinal perforation in patient with COVID-19 infection treated with tocilizumab and corticosteroids. Report of a clinical case].Cirugia espanola · 2021Article
- Article
- Translating IL-6 biology into effective treatments.Nature reviews. Rheumatology · 2020Review
- Interleukin-6 inhibition in the management of non-infectious uveitis and beyond.Journal of ophthalmic inflammation and infection · 2019Review
- Clazakizumab in late antibody-mediated rejection: study protocol of a randomized controlled pilot trial.Trials · 2019Article
- Article
- Tocilizumab in the treatment of rheumatoid arthritis: an evidence-based review and patient selection.Drug design, development and therapy · 2019Review
- Gastrointestinal Perforations with Biologics in Patients with Rheumatoid Arthritis: Implications for Clinicians.Drug safety · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe aim of this study was to use multiple data sources to update information on gastrointestinal perforations (GIPs) during tocilizumab (TCZ) treatment in patients with rheumatoid arthritis (RA).
methodsReporting rates of GIP events were estimated from three distinct patient data sets: a TCZ-IV RA clinical trial all-exposure population, a global TCZ postmarketing safety database population, and a US healthcare claims database population of patients with RA, including patients who received TCZ, anti-tumor necrosis factor (aTNF) agents, or abatacept.
resultsThe clinical trial, global postmarketing, and healthcare claims populations provided 17,906, 382,621, and 3268 patient-years (PYs) of TCZ exposure, respectively. GIP incidence rates [95% confidence interval (CI)] were 1.9 (1.3-2.7), 1.2 (1.1-1.3), and 1.8 (0.7-4.0; specific definition) to 2.8 (1.3-5.2; sensitive definition) per 1000 PYs for the clinical trial, postmarketing, and healthcare claims populations, respectively. The GIP incidence rate (95% CI) for the comparator aTNF healthcare claims population ranged from 0.6 (0.3-1.2) to 0.9 (0.5-1.5) per 1000 PYs, for an absolute rate difference between TCZ and aTNFs of 1.2 (-0.3 to 2.5) to 1.9 (0.0-3.7) per 1000 PYs, corresponding to a number needed to harm between 533 and 828.
conclusionThe TCZ GIP event rates from multiple data sources were consistent with previously reported rates, did not increase over time, and were significantly associated with the number of prior biologics. Comparison of GIP incidence rates among patients with prior biologic exposure suggests that, for every 1000 patients treated with TCZ per year, an additional 1-2 GIP events might occur compared with patients treated with aTNFs.
fundingRoche.
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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.