PMID- 38291690
OWN - NLM
STAT- MEDLINE
DCOM- 20240201
LR  - 20240206
IS  - 1536-4801 (Electronic)
IS  - 0277-2116 (Linking)
VI  - 78
IP  - 1
DP  - 2024 Jan
TI  - Identifying risk factors of anti-TNF induced skin lesions and other adverse 
      events in paediatric patients with inflammatory bowel disease.
PG  - 95-104
LID - 10.1002/jpn3.12066 [doi]
AB  - 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. 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. 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 microg/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). 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.
CI  - (c) 2023 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition 
      and North American Society for Pediatric Gastroenterology, Hepatology, and 
      Nutrition.
FAU - van Hoeve, Karen
AU  - van Hoeve K
AD  - Department of Paediatric gastroenterology & Hepatology & Nutrition, University 
      Hospitals Leuven, KU Leuven, Leuven, Belgium.
FAU - Thomas, Debby
AU  - Thomas D
AD  - Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, 
      Belgium.
FAU - Hillary, Tom
AU  - Hillary T
AD  - Department of Dermatology, University Hospitals Leuven, KU Leuven, Leuven, 
      Belgium.
FAU - Hoffman, Ilse
AU  - Hoffman I
AD  - Department of Paediatric gastroenterology & Hepatology & Nutrition, University 
      Hospitals Leuven, KU Leuven, Leuven, Belgium.
FAU - Dreesen, Erwin
AU  - Dreesen E
AD  - Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, 
      Belgium.
LA  - eng
GR  - Mundipharma Comm. VA and Celltrion Healthcare Co./
GR  - AbbVie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, UCB Pharma/
GR  - Janssen, R-Biopharm, and Prometheus/
PT  - Journal Article
DEP - 20231210
PL  - United States
TA  - J Pediatr Gastroenterol Nutr
JT  - Journal of pediatric gastroenterology and nutrition
JID - 8211545
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 0 (Gastrointestinal Agents)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Humans
MH  - Female
MH  - Child
MH  - Tumor Necrosis Factor Inhibitors/therapeutic use
MH  - Gastrointestinal Agents/adverse effects
MH  - Remission Induction
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Infliximab/adverse effects
MH  - *Crohn Disease/drug therapy
MH  - *Colitis, Ulcerative/drug therapy
MH  - *Skin Diseases/chemically induced/drug therapy
MH  - Risk Factors
OTO - NOTNLM
OT  - adverse events
OT  - child
OT  - inflammatory bowel disease
OT  - infliximab
OT  - skin lesions
EDAT- 2024/01/31 06:43
MHDA- 2024/02/01 06:42
CRDT- 2024/01/31 00:53
PHST- 2023/10/27 00:00 [revised]
PHST- 2023/06/02 00:00 [received]
PHST- 2023/11/02 00:00 [accepted]
PHST- 2024/02/01 06:42 [medline]
PHST- 2024/01/31 06:43 [pubmed]
PHST- 2024/01/31 00:53 [entrez]
AID - 10.1002/jpn3.12066 [doi]
PST - ppublish
SO  - J Pediatr Gastroenterol Nutr. 2024 Jan;78(1):95-104. doi: 10.1002/jpn3.12066. 
      Epub 2023 Dec 10.