Infliximab in young paediatric IBD patients: it is all about the dosing
Paediatric IBD Porto group of ESPGHAN
(2020) European Journal of Pediatrics, volume 179, issue 12, pp. 1935 - 1944
(Article)
Abstract
Infliximab (IFX) is administered intravenously using weight-based dosing (5 mg/kg) in inflammatory bowel disease (IBD) patients. Our hypothesis is that especially young children need a more intensive treatment regimen than the current weight-based dose administration. We aimed to assess IFX pharmacokinetics (PK), based on existing therapeutic drug monitoring (TDM) data in
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IBD patients < 10 years. TDM data were collected retrospectively in 14 centres. Children treated with IFX were included if IFX was started as IBD treatment at age < 10 years (young patients, YP) and PK data were available. Older IBD patients aged 10–18 years were used as controls (older patients, OP). Two hundred and fifteen paediatric inflammatory bowel disease (PIBD) patients were eligible for the study (110 < 10 year; 105 ≥ 10 years). Median age was 8.3 years (IQR 6.9–8.9) in YP compared with 14.3 years (IQR 12.8–15.6) in OP at the start of IFX. At the start of maintenance treatment, 72% of YP had trough levels below therapeutic range (< 5.4 μg/mL). After 1 year of scheduled IFX maintenance treatment, YP required a significantly higher dose per 8 weeks compared with OP (YP; 9.0 mg/kg (IQR 5.0–12.9) vs. OP; 5.5 mg/kg (IQR 5.0–9.3); p < 0.001). The chance to develop antibodies to infliximab was relatively lower in OP than YP (0.329 (95% CI − 1.2 to − 1.01); p < 0.001), while the overall duration of response to IFX was not significantly different (after 2 years 53% (n = 29) in YP vs. 58% (n = 45) in OP; p = 0.56). Conclusion: Intensification of the induction scheme is suggested for PIBD patients aged < 10 years.What is Known?What is New?
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Keywords: Anti-TNF, Biologics, Clinical pharmacology, Crohn’s disease, Gastroenterology, Paediatric, Ulcerative colitis, Crohn's disease, Pediatrics, Perinatology, and Child Health, Journal Article
ISSN: 0340-6199
Publisher: Springer Verlag
Note: Funding Information: KLK received fees for giving lectures and consultancy from Abbvie, Biocodex, MSD and Tillotts Pharma and a research grant for PIBD research from Paediatric Research Foundation (Finland), and JB received personal fees, consultation and congress support from MSD, AbbVie, Nutricia, Nestlé, Biocodex, Walmark and Ferring. AA received research grants from Abbvie and Janssen and consultant fee from Abbvie. DSS received consultation and lecturing frees from AbbVie and a research grant from Takeda. EW Advisory board for AbbVie and travel awards from AbbVie and Janssen over the last 24 months. CMV received honoraria, speaker’s fees and/or congress fees from AbbVie, MSD, Nestle and Biogen. LdR received personal fees, consultation and congress support from Shire, Malinckrodt, Nestlé, Celltrion, Merck, Janssen biologics, Abbvie and Pfizer. Publisher Copyright: © 2020, The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
(Peer reviewed)