Gut. 2022 Jan;71(1):34-42. doi: 10.1136/gutjnl-2020-322339.Epub 2020 Dec 31.

Maria M E Jongsma ¹, Martine A Aardoom ¹, Martinus A Cozijnsen ¹, Merel van Pieterson ¹, Tim de Meij ², Michael Groeneweg ³, Obbe F Norbruis ⁴, Victorien M Wolters ⁵, Herbert M van Wering ⁶, Iva Hojsak ^7 8, Kaija-Leena Kolho ^9 10, Thalia Hummel ¹¹, Janneke Stapelbroek ¹², Cathelijne van der Feen ¹³, Patrick F van Rheenen ¹⁴, Michiel P van Wijk ², Sarah T A Teklenburg-Roord ⁴, Marco W J Schreurs ¹⁵, Dimitris Rizopoulos ¹⁶, Michail Doukas ¹⁷, Johanna C Escher ¹, Janneke N Samsom ¹⁸, Lissy de Ridder ¹⁹

Author information

¹Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.

²Paediatric Gastroenterology, University Medical Center Amsterdam-Location VUmc, Amsterdam, The Netherlands.

³Paediatrics, Maasstad Hospital, Rotterdam, The Netherlands.

⁴Paediatrics, Isala Hospital, Zwolle, The Netherlands.

⁵Paediatric Gastroenterology, Utrecht Medical Center/Wilhelmina Children's Hospital, Utrecht, The The Netherlands.

⁶Paediatrics, Amphia Hospital, Breda, The Netherlands.

⁷Referral centre for Paediatric Gastroenterology and Nutrition, Children's Hospital Zagreb, Zagreb, Croatia.

⁸University JJ Strossmayer, School of Medicine Osijek, Osijek, Croatia.

⁹Paediatric Gastroenterology, Children's Hospital, University of Tampere, Helsinki, Finland.

¹⁰Tampere University, Tampere, Finland.

¹¹Paediatrics, Medical Spectrum Twente, Enschede, The Netherlands.

¹²Paediatrics, Catharina Hospital, Eindhoven, The Netherlands.

¹³Paediatrics, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.

¹⁴Paediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.

¹⁵Immunology, Erasmus MC, Rotterdam, The Netherlands.

¹⁶Biostatistics, Erasmus MC, Rotterdam, The Netherlands.

¹⁷Pathology, Erasmus MC, Rotterdam, The Netherlands.

¹⁸Laboratory of Pediatrics, Division of Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.

¹⁹Paediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands l.deridder@erasmusmc.nl.

Abstract

Objective: In newly diagnosed paediatric patients with moderate-to-severe Crohn's disease (CD), infliximab (IFX) is initiated once exclusive enteral nutrition (EEN), corticosteroid and immunomodulator therapies have failed. We aimed to investigate whether starting first-line IFX (FL-IFX) is more effective to achieve and maintain remission than conventional treatment.

Design: In this multicentre open-label randomised controlled trial, untreated patients with a new diagnosis of CD (3-17 years old, weighted Paediatric CD Activity Index score (wPCDAI) >40) were assigned to groups that received five infusions of 5 mg/kg IFX at weeks 0, 2, 6, 14 and 22 (FL-IFX), or EEN or oral prednisolone (1 mg/kg, maximum 40 mg) (conventional). The primary outcome was clinical remission on azathioprine, defined as a wPCDAI <12.5 at week 52, without need for treatment escalation, using intention-to-treat analysis.

Results: 100 patients were included, 50 in the FL-IFX group and 50 in the conventional group. Four patients did not receive treatment as per protocol. At week 10, a higher proportion of patients in the FL-IFX group than in the conventional group achieved clinical (59% vs 34%, respectively, p=0.021) and endoscopic remission (59% vs 17%, respectively, p=0.001). At week 52, the proportion of patients in clinical remission was not significantly different (p=0.421). However, 19/46 (41%) patients in the FL-IFX group were in clinical remission on azathioprine monotherapy without need for treatment escalation vs 7/48 (15%) in the conventional group (p=0.004).

Conclusions: FL-IFX was superior to conventional treatment in achieving short-term clinical and endoscopic remission, and had greater likelihood of maintaining clinical remission at week 52 on azathioprine monotherapy.

Trial registration number: ClinicalTrials.gov Registry (NCT02517684).