ArticleDrug safety2013
Ischaemic colitis in rheumatoid arthritis patients receiving tumour necrosis factor-α inhibitors: an analysis of reports to the US FDA Adverse Event Reporting System.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- ACG clinical guideline: epidemiology, risk factors, patterns of presentation, diagnosis, and management of colon ischemia (CI).The American journal of gastroenterology · 2015Guideline
- Assessing the association between drug use and ischaemic colitis: a retrospective pharmacovigilance study using FDA Adverse Event data.BMJ open · 2025Article
- Abdominal pain and haematochezia in a 45-year-old woman with rheumatoid arthritis receiving adalimumab treatment.BMJ case reports · 2021Article
- Anti-Inflammatory Biologics and Anti-Tumoral Immune Therapies-Associated Colitis: A Focused Review of Literature.Gastroenterology research · 2018Review
- Discovering adverse drug events combining spontaneous reports with electronic medical records: a case study of conventional DMARDs and biologics for rheumatoid arthritis.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2017Article
- Update on the Diagnosis and Management of Colon Ischemia.Current treatment options in gastroenterology · 2016Article
- Sumatriptan-associated ischemic colitis: case report and review of the literature and FAERS.Drug safety · 2014Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTumour necrosis factor-α (TNF-α) inhibitors are immunosuppressants, approved for the treatment and maintenance of rheumatoid arthritis (RA). Immunosuppression has been shown to induce ischaemic colitis (IC) in an animal model; however, a relationship between TNF inhibitors and IC has rarely been reported in the published literature.
objectiveThe aim of this study was to better characterize the association between TNF-α inhibitors with IC in RA patients, by analysing adverse event reports submitted to the US FDA Adverse Event Reporting System (AERS) and the published literature.
methodsThe FDA AERS database was searched and we identified all reports between January 2003 and June 2011. The search was limited to an indication of RA, a 'primary suspect' drug of TNF-α inhibitors and a reaction of IC. Full-length reports were obtained and analysed utilizing the Freedom of Information Act. The cases were organized by age, sex, type of TNF-α inhibitor, concomitant drugs and medical co-morbidities. Cases were labelled as definite, probable, possible or doubtful drug-induced adverse events based on the Naranjo Scale. A PubMed search was performed to obtain published literature documenting events of anti-TNF-associated IC.
resultsTwelve cases were eliminated because of more likely causes for IC. Thirty-five primary suspect reports of TNF-α inhibitors associated with IC in RA patients were identified in the FDA AERS. Thirteen cases were reported with infliximab, 12 with adalimumab, 7 with etanercept and 3 with certolizumab. The majority of the cases were in females (29/35) and those between the ages of 50 and 65 years (18/35). Use of the Naranjo Scale revealed 17 probable and 18 possible cases of anti-TNF-induced IC. In the literature, one report of IC associated with adalimumab was identified.
conclusionTNF-α inhibitors may be initiating factors or co-factors in the development of IC in RA patients, and further research to determine the mechanism of this association is warranted.
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Registered trials
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