Proactive Drug Monitoring Versus Clinically Based Dosing for Endoscopic Healing in Pediatric Crohn's Disease
Ben Kang1, Eun Sil Kim2, Sujin Choi1
1Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Korea.
Insights
Proactive therapeutic drug monitoring (TDM) for infliximab in pediatric Crohn's disease (CD) significantly improved endoscopic healing and sustained corticosteroid-free remission compared to clinical dosing. This proactive approach offers a superior strategy for managing pediatric CD patients.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Clinical Therapeutics
Background:
- Crohn's disease (CD) is a chronic inflammatory bowel disease affecting children.
- Current treatment strategies for pediatric CD often involve biologic therapies like infliximab (IFX).
- Optimizing IFX dosing through therapeutic drug monitoring (TDM) is crucial for treatment efficacy.
Purpose of the Study:
- To evaluate if proactive dosing of infliximab (IFX) guided by TDM improves endoscopic healing (EH) in pediatric CD patients compared to clinically based dosing.
- To assess the impact of proactive IFX dosing on sustained corticosteroid-free clinical remission (SCFCR).
Main Methods:
- A non-blinded, randomized controlled trial involving 112 biologic-naïve pediatric CD patients.
- Patients were randomized into two groups: proactive TDM-guided dosing and clinically based dosing.
- The primary endpoint was endoscopic healing (EH) at week 54.
Main Results:
- Proactive TDM dosing resulted in significantly higher rates of EH (80.0%) compared to clinical dosing (57.1%) (P = .025).
- Sustained corticosteroid-free clinical remission (SCFCR) was also higher in the proactive arm (89.3%) versus the clinical arm (69.6%) (P = .019).
- Proactive dosing was identified as an independent factor associated with both EH and SCFCR.
Conclusions:
- Proactive TDM-guided infliximab dosing is superior to clinically based dosing for achieving endoscopic healing in pediatric Crohn's disease.
- This proactive strategy also demonstrates improved outcomes in sustained corticosteroid-free clinical remission.
- The findings support the implementation of proactive TDM for optimizing IFX treatment in pediatric CD.
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.
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