Therapeutic drug monitoring has been proposed as a useful tool in the management of infliximab (IFX) treated patients with inflammatory bowel disease. The aim of this retrospective study was to determine whether IFX trough levels after induction therapy are predictive for outcome at week 52.
All pediatric patients with inflammatory bowel disease receiving maintenance IFX at our centre, with IFX trough level available at their first maintenance infusion and a follow-up of at least 52 weeks were included. IFX induction regimens could be intensified at the discretion of the treating physician. All children received proactive drug monitoring during maintenance with dose adaptation aiming to target a therapeutic window of 3 to 7 μg/mL.
We included 35 children (23 with Crohn disease and 12 with ulcerative colitis). Median IFX trough levels just before the first maintenance infusion were significantly higher in children achieving clinical (4.6 μg/mL [2.7–11.8] vs 1.5 μg/mL [0.9–3.0]), biological (4.6 μg/mL [2.5–10.3] vs 2.6 μg/mL [0.3–3.2]) and combined clinical/biological remission (6.0 μg/mL [3.2–12.0] vs 2.6 μg/mL [1.1–3.2]) at week 52 compared to children not meeting these criteria (all P ≤ 0.002). Binary logistic regression identified these trough levels as the only predictor for the same outcomes with an odds ratio (95% confidence interval) of 2.083 (1.085–3.998), 2.203 (1.101–4.408), and 2.264 (1.096–4.680), respectively (all P < 0.05).
Adequate IFX exposure during induction therapy is associated with better clinical and/or biological remission at week 52. Postinduction IFX trough levels were the only predictor for clinical and/or biological remission at week 52.
*Department of Paediatric gastroenterology and Hepatology and Nutrition, University Hospitals Leuven
†TARGID, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA)
‡Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences
§Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Address correspondence and reprint requests to Séverine Vermeire, MD, PhD, Department of Gastroenterology and Hepatology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium (e-mail: firstname.lastname@example.org).
Received 29 June, 2018
Accepted 6 December, 2018
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K.H. is currently receiving a research grant from Mundipharma Comm. VA and Celltrion Healthcare Co. I.H. reports having received lecture fee and payment for travel expenses from Nutrica, Nestlé, Mead Johnson, Abbvie. G.V.A. reports having received research grant from Abbvie; in addition consultancy fee from Abbvie, MSD, Ferring, Takeda, Janssen, Pfizer Inc, Gilead, and Tigenix. G.V.A. is a senior clinical investigators of the Research Foundation—Flanders (FWO). M.F. reports having received research grant from Janssen, Takeda; in addition consultancy fee from AbbVie, Boehringer Ingelheim, Ferring, Janssen, Mitsubishi Tanabe, MSD, Pfizer, and a speakers fee from AbbVie, Boehringer Ingelheim, Chiesi, Ferring, Janssen, Lamepro, Mitsubishi Tanabe, MSD, Pfizer, Tramedico, Tillotts, Zeria. M.F. is a senior clinical investigators of the Research Foundation—Flanders (FWO). A.G. reports having received lecture fee from MSD, Janssen Biologicals, Pfizer, Takeda, Abbvie; in addition she is on the advisory board from Takeda and reports having received financial research support from Pfizer, MSD and license agreement from R-biopharm, apDia, Merck. S.V. reports having received research grant from Takeda, MSD, Abbvie, Pfizer; in addition consultancy fee from Abbvie, MSD, Takeda, Shire, Pfizer Inc, Galapagos, Genentech/Roche, Celgene, Second Genome, Arena and Gilead. S.V. is a senior clinical investigators of the Research Foundation—Flanders (FWO). E.D. reports no conflicts of interest.