Netherlands: First-line infliximab (FL-IFX) is more effective than conventional treatment in achieving and maintaining remission in pediatric patients with newly diagnosed moderate-to-severe Crohn's disease (CD), finds a recent study in the BMJ journal Gut. Maria M E Jongsma,
In newly diagnosed paediatric patients with moderate-to-severe CD, infliximab (IFX) is initiated once exclusive enteral nutrition (EEN), corticosteroid and immunomodulator therapies have failed. Maria M E Jongsma, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands, and colleagues aimed to investigate whether starting first-line IFX (FL-IFX) is more effective to achieve and maintain remission than conventional treatment.
The multicentre open-label randomised controlled trial included 100 untreated patients with a new diagnosis of CD (3–17 years old, weighted Paediatric CD Activity Index score (wPCDAI) >40). They were assigned to groups that received five infusions of 5 mg/kg IFX at weeks 0, 2, 6, 14 and 22 (FL-IFX; n=50) or EEN or oral prednisolone (1 mg/kg, maximum 40 mg) (conventional; n=50). Four patients did not receive treatment as per protocol.
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.
Key findings of the study include:
At week 10, a higher proportion of patients in the FL-IFX group than in the conventional group achieved clinical (59% vs 34%, respectively) and endoscopic remission (59% vs 17%, respectively).
At week 52, the proportion of patients in clinical remission was not significantly different.
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.
"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," wrote the authors.
The study titled, "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," is published in the BMJ journal Gut.
DOI: https://gut.bmj.com/content/early/2020/12/31/gutjnl-2020-322339