Proactive Drug Monitoring Versus Clinically Based Dosing for Endoscopic Healing in Pediatric Crohn's Disease Receiving Infliximab.

Background & Aims: Proactive dosing based on therapeutic drug monitoring (TDM) of adalimumab is associated with higher rates of sustained corticosteroid-free clinical remission (SCFCR) in children with Crohn's disease (CD) than that with reactive TDM. We aimed to investigate whether proactive dosing of infliximab (IFX) based on TDM is associated with higher rates of endoscopic healing (EH) in pediatric patients with CD than that with clinically based dosing.

Methods: We conducted a non-blinded, randomized controlled trial of 112 biologic-naïve children with CD who had responded to IFX induction treatment at 4 centers in South Korea between July 2017 and November 2020. Patients were randomly assigned to receive dosing based on proactive TDM (proactive arm) or clinically based dosing (clinical arm). The primary endpoint was EH at week 54.

Results: The primary endpoint was achieved in 80.0% (40/50) of the proactive arm and 57.1% (28/49) of the clinical arm (P = .025). SCFCR was achieved in 69.6% (39/56) of the clinical arm and 89.3% (50/56) of the proactive arm at week 54 of treatment (P = .019). According to the multivariate logistic regression analysis, the intervention group (proactive arm vs clinical arm) was an independent factor associated with EH (odds ratio, 3.48; 95% confidence interval, 1.26-10.43; P = .019) and SCFCR (odds ratio, 5.50; 95% confidence interval, 1.72-21.61; P = .007).

Conclusions: Dosing based on proactive TDM was superior to clinically based dosing in terms of EH in a randomized controlled trial of pediatric CD. Trial identifier: cris.nih.go.kr: KCT0005190.