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

Ben Kang; Eun Sil Kim; Sujin Choi; Byung-Ho Choe; Jin Soo Moon; Jae Sung Ko; Sangjun Sohn; Yeoun Joo Lee; Yiyoung Kwon; Mi Jin Kim; Tae Yeon Jeon; So Mi Lee; Seunghyun Lee; Youngcheol Ju; Yon Ho Choe

doi:10.1016/j.cgh.2025.04.025

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

Clin Gastroenterol Hepatol. 2025 May 14:S1542-3565(25)00412-4. doi: 10.1016/j.cgh.2025.04.025. Online ahead of print.

Authors

Ben Kang¹, Eun Sil Kim², Sujin Choi¹, Byung-Ho Choe¹, Jin Soo Moon³, Jae Sung Ko³, Sangjun Sohn⁴, Yeoun Joo Lee⁴, Yiyoung Kwon⁵, Mi Jin Kim⁶, Tae Yeon Jeon⁷, So Mi Lee⁸, Seunghyun Lee⁹, Youngcheol Ju¹⁰, Yon Ho Choe¹¹

Affiliations

¹ Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Korea.
² Department of Pediatrics, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
³ Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
⁴ Department of Pediatrics, Pusan National University Yangsan Hospital, College of Medicine, Pusan National University, Yangsan, Korea.
⁵ Department of Pediatrics, School of Medicine, Inha University, Incheon, Korea.
⁶ Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
⁷ Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
⁸ Department of Radiology, School of Medicine, Kyungpook National University, Daegu, Korea.
⁹ Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.
¹⁰ Research and Development Department, Celltrion Pharm, Inc., Seoul, Korea.
¹¹ Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: i101016@skku.edu.

PMID: 40378994
DOI: 10.1016/j.cgh.2025.04.025

Abstract

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.

Keywords: Crohn’s Disease; Infliximab; Pediatric; Proactive Dosing; Therapeutic Drug Monitoring.