Randomized trial comparing 5-year follow-up of first-line infliximab to conventional therapy in paediatric Crohn's disease.

Authors

S A Vuijk, M M E Jongsma, M A Cozijnsen, M van Pieterson, T G J de Meij, M Groeneweg, V M Wolters, H van Wering, I Hojsak, K-L Kolho, T Hummel, J Stapelbroek, C van der Feen, P F van Rheenen, M P van Wijk, S Teklenburg-Roord, J M Pruijsen- Nienhuis, D Rizopoulos, J C Escher, J N Samsom, L de Ridder

Published in

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. Jul 04, 2026. Epub Jul 04, 2026.

Abstract

The TISKids study previously demonstrated that first-line infliximab (FL-IFX) was more effective than conventional treatment in achieving clinical remission without treatment escalation at 52 weeks in children with moderate-to-severe Crohn's disease (CD). We investigated 5-year outcomes.
The TISKids is a multicentre, open-label randomised controlled trial in newly diagnosed, untreated CD patients aged 3-17 years (wPCDAI>40). Patients were randomised to FL-IFX (five IFX infusions, then stopped) or conventional treatment (exclusive enteral nutrition or prednisolone). Both groups received azathioprine maintenance. The primary outcome was sustained clinical remission (wPCDAI<12.5, CDAI<150 or PGA remission) without additional CD-related therapy at 5 years. Secondary outcomes included time to (re)start IFX or another biological.
One-hundred patients were randomised; six were lost to follow-up. At 5 years, sustained clinical remission without additional CD-related therapy was observed in 3/48 (6%) FL-IFX patients versus 1/46 (2%) of conventionally treated patients(p=0.617), whilst 42/48 (88%) in FL-IFX and 44/46 conventionally treated patients required additional CD-related treatment (p=0.271). Median time to (re)start of biologic therapy was 65 weeks [95%CI 53-122] for FL-IFX versus 31 weeks [95%CI 22-57] for conventional treatment (p=0.037).
After 5-years follow-up in the TISKids trial, we found that almost all patients required additional CD-related treatment, irrespective of induction therapy with five infusion of FL-IFX or conventional treatment. FL-IFX delayed the need for additional biological treatment, indicating its potential as preferred treatment option for patients with moderate-to-severe CD at diagnosis. These findings underscore that patients with moderate-to-severe CD require early and maintained treatment with infliximab.

PMID:
42401249
Bibliographic data and abstract were imported from PubMed on 05 Jul 2026.

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