ArticlePaediatric drugs2018
Serious Adverse Events Associated with Anti-Tumor Necrosis Factor Alpha Agents in Pediatric-Onset Inflammatory Bowel Disease and Juvenile Idiopathic Arthritis in A Real-Life Setting.
Article in Paediatric drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Renal manifestations in inflammatory bowel disease: a systematic review.Journal of gastroenterology · 2022Pooled it
- Safety of infliximab and adalimumab in pediatric inflammatory bowel diseases: a disproportionality analysis from the FAERS database.BMC gastroenterology · 2025Article
- Efficacy of High-Dose Methylprednisolone in Inducing Remission in Pediatric Acute Severe Ulcerative Colitis: Retrospective Study.Journal of clinical medicine · 2025Article
- Unveiling the differences: infection disorders associated with tumor necrosis factor α inhibitors in pediatric patients-a pharmacovigilance study (2004-2023).European journal of pediatrics · 2025Article
- Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease-Reports from a Romanian Center.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Past, Present and (Foreseeable) Future of Biological Anti-TNF Alpha Therapy.Journal of clinical medicine · 2023Review
- Causal association of juvenile idiopathic arthritis-associated uveitis with depression and anxiety: a bidirectional Mendelian randomization study.International ophthalmology · 2023Article
- Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB).BMC gastroenterology · 2022Article
- Paradoxical Reactions to Biologicals in Chronic Inflammatory Systemic Diseases.Deutsches Arzteblatt international · 2022Article
- The Emerging Role of Noncoding RNAs in Pediatric Inflammatory Bowel Disease.Inflammatory bowel diseases · 2020Article
- Recent advances in understanding and managing pediatric inflammatory bowel disease.F1000Research · 2019Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesAnti-tumor necrosis factor alpha (anti-TNF-α) agents are generally well tolerated, yet they can be associated with serious adverse events (SAEs) in a minority of patients. We examined the incidence of SAEs in a pediatric referral center for chronic rheumatologic and gastroenterological inflammatory disorders.
methodsRetrospective analysis of SAEs occurring during treatment with anti-TNF-α agents in patients with juvenile idiopathic arthritis (JIA) (n = 78) or pediatric-onset inflammatory bowel disease (IBD) (n = 105) seen at the Institute for Maternal and Child Health IRCCS "Burlo Garofolo" in Trieste, Italy, between June 2001 and February 2016. Only SAEs grade 3-5 according to the Common Terminology Criteria for Adverse Events version 4.03 and/or requiring definitive therapy discontinuation were reported.
resultsTotal anti-TNF-α exposure was 390.5 patient-years (PYs). The overall incidence rate of SAEs for etanercept was 4.14/100 PYs. Four patients developed uveitis, two had anxiety disorders, one had a serious zoster infection, and one developed TNF-α antagonist-induced lupus-like syndrome (TAILS). The overall incidence rate of SAEs for infliximab was 22.49/100 PYs. The most common SAEs were anaphylactoid reactions (n = 18), followed by infectious events (n = 9) and TAILS (n = 3). The overall incidence rate of SAEs for adalimumab was 4.71/100 PYs (two infectious SAEs). No malignancies or deaths were observed. A greater incidence rate of infectious SAEs was observed in IBD patients receiving infliximab compared to JIA patients receiving etanercept (8.11 vs 0.52 per 100 PYs).
conclusionsAnti-TNF-α therapy was generally well tolerated. SAEs leading to anti-TNF-α discontinuation were rare and non-fatal. Infliximab was associated with the highest incidence of SAEs. Infectious SAEs were more frequently observed in IBD patients treated with infliximab than in JIA patients receiving etanercept.
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