Details

Autor(en) / Beteiligte

• Jongsma, Maria M. E.
• Winter, Dwight A.
• Huynh, Hien Q.
• Norsa, Lorenzo
• Hussey, Seamus
• Kolho, Kaija-Leena
• Bronsky, Jiri
• Assa, Amit
• Cohen, Shlomi
• Lev-Tzion, Raffi
• Van Biervliet, Stephanie
• Rizopoulos, Dimitris
• de Meij, Tim G. J.
• Shouval, Dror S.
• Wine, Eytan
• Wolters, Victorien M.
• Martinez-Vinson, Christine
• de Ridder, Lissy

Titel

Infliximab in young paediatric IBD patients: it is all about the dosing

Ist Teil von

• European journal of pediatrics, 2020-12, Vol.179 (12), p.1935-1944

Ort / Verlag

Berlin/Heidelberg: Springer Berlin Heidelberg

Erscheinungsjahr

2020

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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 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? •Infliximab trough levels of paediatric IBD patients are influenced by several factors as dosing scheme, antibodies and inflammatory markers. •In 4.5–30% of the paediatric IBD patients, infliximab treatment was stopped within the first year. What is New? •The majority of young PIBD (< 10 years) have inadequate IFX trough levels at the start of maintenance treatment. •Young PIBD patients (< 10 years) were in need of a more intensive treatment regimen compared with older paediatric patients during 1 year of IFX treatment. •The chance to develop antibodies to infliximab was relatively higher in young PIBD patients (< 10 years).