PT  - JOURNAL ARTICLE
AU  - Maria M E Jongsma
AU  - Martine A Aardoom
AU  - Martinus A Cozijnsen
AU  - Merel van Pieterson
AU  - Tim de Meij
AU  - Michael Groeneweg
AU  - Obbe F Norbruis
AU  - Victorien M Wolters
AU  - Herbert M van Wering
AU  - Iva Hojsak
AU  - Kaija-Leena Kolho
AU  - Thalia Hummel
AU  - Janneke Stapelbroek
AU  - Cathelijne van der Feen
AU  - Patrick F van Rheenen
AU  - Michiel P van Wijk
AU  - Sarah T A Teklenburg-Roord
AU  - Marco W J Schreurs
AU  - Dimitris Rizopoulos
AU  - Michail Doukas
AU  - Johanna C Escher
AU  - Janneke N Samsom
AU  - Lissy de Ridder
TI  - First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn’s disease: an open-label multicentre randomised controlled trial
AID  - 10.1136/gutjnl-2020-322339
DP  - 2022 Jan 01
TA  - Gut
PG  - 34--42
VI  - 71
IP  - 1
4099  - http://gut.bmj.com/content/71/1/34.short
4100  - http://gut.bmj.com/content/71/1/34.full
SO  - Gut2022 Jan 01; 71
AB  - 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).No data are available. The data that support the findings of this study are available from the corresponding author, upon reasonable request.