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Published on: October 14, 2025
Adalimumab therapy in children with Crohn disease previously treated with infliximab
Martinus Cozijnsen1, Vera Duif, Freddy Kokke
1*Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam †Pediatric Gastroenterology, Radboud University Nijmegen Medical Centre, Nijmegen ‡Pediatric Gastroenterology, Wilhelmina Children's Hospital-University Medical Center, Utrecht §Pediatric Gastroenterology, Emma Children's Hospital-Academic Medical Center, Amsterdam ||Pediatric Gastroenterology, Beatrix Children's Hospital-University Medical Center Groningen, Groningen ¶Pediatric Gastroenterology, VU University Medical Center, Amsterdam #Pediatric Gastroenterology, Willem-Alexander Kinderziekenhuis-Leiden University Medical Center, Leiden **Pediatric Gastroenterology, Isala Hospital, Zwolle ††Pediatric Gastroenterology, Catharina Hospital, Eindhoven ‡‡Pediatric Gastroenterology, Maastricht University Medical Center, Maastricht §§Pediatric Gastroenterology, Amphia Hospital, Breda ||||Pediatric Gastroenterology, Medisch Spectrum Twente, Enschede ¶¶Pediatric Gastroenterology, Gelre Hospitals, Apeldoorn, The Netherlands.
Insights
Adalimumab effectively treats pediatric Crohn disease (CD) in children previously treated with infliximab (IFX). Two-thirds of patients achieved remission, demonstrating its clinical utility in refractory cases.
Area of Science:
- Gastroenterology
- Immunology
- Pediatric Medicine
Background:
- Adalimumab, an anti-tumor necrosis factor antibody, is effective for adult refractory Crohn disease (CD).
- Limited data exists on adalimumab's efficacy in pediatric CD patients.
- Previous infliximab (IFX) therapy is common in pediatric CD management.
Purpose of the Study:
- To evaluate the real-world efficacy of adalimumab in pediatric CD patients.
- To compare adalimumab's effectiveness in IFX non-responders versus those who lost response to IFX.
Main Methods:
- Retrospective analysis of Dutch pediatric CD patients (<18 years) treated with adalimumab post-IFX.
- Disease activity assessed using weighted Pediatric Crohn's Disease Activity Index (wPCDAI) or physician global assessment (PGA).
- Adverse events (AEs) were monitored.
Main Results:
- 64% of 53 pediatric CD patients achieved remission (wPCDAI < 12.5 or PGA = 0) within a median of 3.3 months.
- Remission was maintained by 50% for 2 years; 21% achieved partial response.
- 34% failed adalimumab due to nonresponse, loss of response, or AEs. IFX non-responders had a significantly higher failure rate (HR 18.8).
- Only one serious AE (nonfatal infection) was reported.
Conclusions:
- Adalimumab is a viable treatment option for pediatric CD refractory to IFX.
- The drug induces remission in approximately two-thirds of these patients in clinical practice.
- Adalimumab demonstrates a favorable safety profile in this pediatric cohort.
Objectives:
Adalimumab, a humanised anti-tumour necrosis factor antibody, is an effective treatment in adult patients with refractory Crohn disease (CD). The available literature on its efficacy in children remains limited. We aimed to evaluate the real-world efficacy in paediatric patients with CD and compare the efficacy between infliximab (IFX) nonresponders and patients who lost response to IFX.
Methods:
All Dutch patients with CD receiving adalimumab before the age of 18 years after previous IFX therapy were identified. We analysed longitudinal disease activity, assessed by the mathematically weighted Pediatric Crohn's Disease Activity Index (wPCDAI) or the physician global assessment (PGA), and adverse events (AEs).
Results:
Fifty-three patients with CD were included. Twelve patients received monotherapy and the others received combination treatment with thiopurines (n = 21), methotrexate (n = 11), steroids (n = 7), or exclusive enteral nutrition (n = 2). Median follow-up was 12 months (interquartile range 5-23). Remission was reached in 34 patients (64%, wPCDAI < 12.5 or PGA = 0) after a median of 3.3 months, and maintained by 50% for 2 years. Eleven patients (21%) reached response but not remission (decrease in wPCDAI ≥ 17.5 or decrease in PGA). Eighteen patients (34%) failed adalimumab treatment because of nonresponse (n = 4), lost response (n = 11), or AEs (n = 3). More IFX nonresponders failed adalimumab treatment than patients who lost response to IFX (2/3 vs 8/34, hazard ratio 18.8, 95% confidence interval 1.1-303.6). Only 1 patient encountered a serious AE, a severe but nonfatal infection.
Conclusions:
In clinical practice, adalimumab induces remission in two-thirds of children with IFX refractory CD.
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