TY - JOUR
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
AU - Jongsma, Maria M. E.
AU - Aardoom, Martine A.
AU - Cozijnsen, Martinus A.
AU - van Pieterson, Merel
AU - de Meij, Tim
AU - Groeneweg, Michael
AU - Norbruis, Obbe F.
AU - Wolters, Victorien M.
AU - van Wering, Herbert M.
AU - Hojsak, Iva
AU - Kolho, Kaija-Leena
AU - Hummel, Thalia
AU - Stapelbroek, Janneke
AU - van der Feen, Cathelijne
AU - van Rheenen, Patrick F.
AU - van Wijk, Michiel P.
AU - Teklenburg-Roord, Sarah T. A.
AU - Schreurs, Marco W. J.
AU - Rizopoulos, Dimitris
AU - Doukas, Michail
AU - Escher, Johanna C.
AU - Samsom, Janneke N.
AU - de Ridder, Lissy
PY - 2021
Y1 - 2021
N2 - 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).
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).
KW - IBD clinical
KW - inflammatory bowel disease
KW - infliximab
KW - paediatric gastroenterology
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85098664412&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33384335
U2 - 10.1136/gutjnl-2020-322339
DO - 10.1136/gutjnl-2020-322339
M3 - Article
C2 - 33384335
JO - Gut
JF - Gut
SN - 0017-5749
ER -