RT Journal Article
SR Electronic
T1 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
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 34
OP 42
DO 10.1136/gutjnl-2020-322339
VO 71
IS 1
A1 Maria M E Jongsma
A1 Martine A Aardoom
A1 Martinus A Cozijnsen
A1 Merel van Pieterson
A1 Tim de Meij
A1 Michael Groeneweg
A1 Obbe F Norbruis
A1 Victorien M Wolters
A1 Herbert M van Wering
A1 Iva Hojsak
A1 Kaija-Leena Kolho
A1 Thalia Hummel
A1 Janneke Stapelbroek
A1 Cathelijne van der Feen
A1 Patrick F van Rheenen
A1 Michiel P van Wijk
A1 Sarah T A Teklenburg-Roord
A1 Marco W J Schreurs
A1 Dimitris Rizopoulos
A1 Michail Doukas
A1 Johanna C Escher
A1 Janneke N Samsom
A1 Lissy de Ridder
YR 2022
UL http://gut.bmj.com/content/71/1/34.abstract
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.