ArticlePharmaceuticals (Basel, Switzerland)2024
Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.
Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative effectiveness and safety of tofacitinib vs. adalimumab in patients with rheumatoid arthritis: A systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- A multidimensional investigation of myelosuppression associated with sintilimab: integrating pharmacovigilance signal mining with real-world clinical evidence.Frontiers in pharmacology · 2026Article
- Real-world safety profile of elexacaftor/tezacaftor/ivacaftor: a disproportionality analysis using the U.S. FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data.Frontiers in drug safety and regulation · 2025Article
- Vonoprazan-related adverse events: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in medicine · 2025Article
- A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for avatrombopag.Scientific reports · 2024Article
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Authors and funding
5 authors.
Funding
Abstract
backgroundAdalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult rheumatoid arthritis (RA), and subsequently approved for pediatric treatment of various autoimmune diseases in children of different ages. Due to genetic differences between children and adults in terms of physiology and immunity, there is a need to explore the safety of adalimumab in children in the real world. The aim of this study is to identify potential adverse event (AE) signals associated with the use of adalimumab in pediatric patients (<18 years old) using data from the FDA Adverse Event Reporting System (FAERS).
methodsAEs associated with adalimumab in pediatric patients reported in the FAERS database from the first quarter (Q1) of 2017 to the third quarter (Q3) of 2022 were systematically gathered. Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), and the empirical Bayes geometric mean (EBGM) were used to assess the relationship between adalimumab and AEs in children.
resultsOut of 8,363,304 reports collected from the FAERS database during the study period, 3819 reports on children on adalimumab were identified. Adalimumab-related AEs reports were concentrated on 10 toxicity areas and a total of 202 positive signals were detected, of which injection site papule (ROR = 261.97) and intestinal fistula (ROR = 122.09) had the strongest signals. Unexpected significant AEs, including intestinal obstruction, immunodeficiency, abdominal abscess, and Takayasu's arteritis might also occur. In comparison with patients of all ages in the same time window, the median onset time of children was shorter (99 vs. 149 days). Most of the AE cases occurred in children within the first 1 (1.71%), 2 (8.12%), and 3 months (8.39%) and had early failure types after adalimumab initiation. Methotrexate, folic acid, prednisone, azathioprine, and mesalamine were the top five drugs used concomitantly for adalimumab-associated AEs.
conclusionsWhen adalimumab is used in children, especially in the first 3 months of treatment, in addition to the AEs recorded in the drug package insert, close attention should be paid to the new potential AEs off-label to ensure the safety of adalimumab in children.
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