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Identifying risk factors of anti-TNF induced skin lesions and other adverse events in paediatric patients with inflammatory bowel disease.
- Source :
-
Journal of pediatric gastroenterology and nutrition [J Pediatr Gastroenterol Nutr] 2024 Jan; Vol. 78 (1), pp. 95-104. Date of Electronic Publication: 2023 Dec 10. - Publication Year :
- 2024
-
Abstract
- Objectives: While higher infliximab (IFX) trough concentrations (TCs) are associated with better outcomes in patients with inflammatory bowel disease (IBD), they could pose a risk for adverse events (AEs), including IFX-induced skin lesions. Therefore, we studied correlations between IFX TCs and occurrence of AEs in paediatric IBD patients.<br />Methods: In this single-centre study, all children with Crohn's disease (CD) and ulcerative colitis (UC) receiving IFX maintenance therapy who underwent proactive drug monitoring between March 2015 and August 2022 were included. IFX doses/intervals/TCs and patient characteristics were systematically registered, as well as AEs and skin lesions appearance.<br />Results: A total of 109 patients (72 CD and 37 UC) contributed 2913 IFX TCs. During a median follow-up of 3.0 [1.5-4.5] years, we observed 684 AEs in 101 patients and 49 skin lesions in 35 patients. There was no significant difference (p = .467) in median TCs between patients with and without skin lesions. However, higher median IFX doses were associated with an increased hazard rate of skin lesions [HR 1.084 (1.024-1.148), p = .005], in addition to female sex [2.210 (1.187-5.310), p = .016] and diagnosis of CD [1.695 (1.241-1.877), p = .011]. Considering IFX therapeutic TC cut-offs of 5.0 and 9.0 µg/mL, there was no significant difference in AE rate (p = .749 and p = .833, respectively). Also, no significant association between IFX doses and AE rate (p = .159).<br />Conclusions: Increasing the IFX dose to achieve therapeutic TCs may not increase the overall risk of AEs in paediatric IBD patients. However, concerns arise regarding the risk of skin lesions, especially in female CD patients.<br /> (© 2023 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)
- Subjects :
- Humans
Female
Child
Tumor Necrosis Factor Inhibitors therapeutic use
Gastrointestinal Agents adverse effects
Remission Induction
Infliximab adverse effects
Risk Factors
Inflammatory Bowel Diseases drug therapy
Crohn Disease drug therapy
Colitis, Ulcerative drug therapy
Skin Diseases chemically induced
Skin Diseases drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1536-4801
- Volume :
- 78
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of pediatric gastroenterology and nutrition
- Publication Type :
- Academic Journal
- Accession number :
- 38291690
- Full Text :
- https://doi.org/10.1002/jpn3.12066