ArticleThe American journal of gastroenterology2012
A pooled analysis of infections, malignancy, and mortality in infliximab- and immunomodulator-treated adult patients with inflammatory bowel disease.
Article in The American journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 4 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
92 citing papers in PubMed, 4 syntheses or guidelines pooled it, 225 citations in OpenAlex.
- Tumor Necrosis Factor-Alpha Inhibitor Use and Malignancy Risk: A Systematic Review and Patient Level Meta-Analysis.Cancers · 2025Pooled it
- Is There a Risk of Lymphoma Associated With Anti-tumor Necrosis Factor Drugs in Patients With Inflammatory Bowel Disease? A Systematic Review of Observational Studies.Frontiers in pharmacology · 2019Pooled it
- Defining quality indicators for best-practice management of inflammatory bowel disease in Canada.Canadian journal of gastroenterology & hepatology · 2014Guideline
- Use of thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel diseases: a meta-analysis.PloS one · 2013Pooled it
- Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease.Inflammatory bowel diseases · 2017Trial
- Predictive value of three nutritional indexes for disease activity in patients with inflammatory bowel disease.Annals of medicine · 2025Article
- Assessment of Azathioprine-Associated Lymphopenia Incidence Rates in Polish Children with Inflammatory Bowel Disease and Autoimmune Hepatitis: A Retrospective Study.Children (Basel, Switzerland) · 2025Article
- Fermented Kamut Wheat Diet Prevents DSS-Induced Colitis via Modulating Gut Microbiota in Mice.International journal of molecular sciences · 2025Article
- Involvement of HLADQA1*05 in Patients with Inflammatory Bowel Disease Treated with Anti-TNF Drugs.Medicina (Kaunas, Lithuania) · 2025Article
- Review
- [Risks of Cancer Associated with Therapeutic Drugs for Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- Higher Ustekinumab Levels in Maintenance Therapy are Associated with Greater Mucosal Healing and Mucosal Response in Crohn's Disease: An Experience of 2 IBD Centers.Inflammatory bowel diseases · 2024Observational
- Article
- The association between inflammatory bowel disease and all-cause and cause-specific mortality in the UK Biobank.Annals of epidemiology · 2023Article
- Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.Inflammatory bowel diseases · 2023Article
- Therapeutic Antibodies in Medicine.Molecules (Basel, Switzerland) · 2023Review
- The Risk of Serious Infections Before and After Anti-TNF Therapy in Inflammatory Bowel Disease: A Retrospective Cohort Study.Inflammatory bowel diseases · 2023Article
- Personalized Treatment for Crohn's Disease: Current Approaches and Future Directions.Clinical and experimental gastroenterology · 2023Review
- Dendritic cell combination therapy reduces the toxicity of triptolide and ameliorates colitis in murine models.Drug delivery · 2022Article
- Advancing Biologic Therapy for Refractory Autoimmune Hepatitis.Digestive diseases and sciences · 2022Review
32 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
10 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe objective of this study was to analyze the safety of long-term infliximab treatment, with/without concomitant immunomodulators, across Crohn's disease (CD) and ulcerative colitis (UC) clinical trials.
methodsTo maximize sample size, we pooled primary safety data across 10 CD or UC trials, including five randomized, controlled trials contributing data from patients who received intravenous infliximab 5 or 10 mg/kg (n=1,713; ±azathioprine) or placebo (n=406; ±azathioprine). Pooled incidences and 95% confidence intervals (CIs) were determined for mortality, infection, and malignancy. Standardized incidence ratios and 95% CIs were also determined for malignancies using the Surveillance, Epidemiology, and End Results database.
resultsWe observed no increase in infections, serious infections, or malignancy with infliximab vs. placebo in these patients with inflammatory bowel disease (IBD). In patients with UC, but not CD, immunomodulator treatment (vs. treatment without immunomodulator) yielded a higher incidence (95% CI) of infections (120.07 (110.66, 130.08)/100 patient-years (pt-yrs) vs. 92.47 (84.54, 100.94)/100 pt-yrs). Among placebo-treated patients with CD, but not UC, those with immunomodulator use demonstrated a higher incidence (95% CI) of malignancy vs. no immunomodulator treatment (1.84 (0.22, 6.66)/100 pt-yrs vs. 0.00 (0.00, 0.00)/100 pt-yrs). Mortality and infection-related mortality appeared unaffected by infliximab or immunomodulator treatment.
conclusionsInfliximab treatment of IBD did not appear to affect incidences of infection, mortality, or malignancy. Relative to patients with no immunomodulator use, immunomodulator-treated UC patients demonstrated a higher incidence of infection and immunomodulator-plus-placebo-treated CD patients demonstrated a higher incidence of malignancy.
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Registered trials
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.