Infliximab (IFX) has been shown to be a promising treatment option for children and adolescents with newly diagnosed moderate to severe Crohn disease (CD), according to the results of a trial published in Gut.
A group of investigators from Erasmus Medical Center conducted a multicenter, open-label, randomized controlled trial that spanned across 12 hospitals in 3 countries (the Netherlands, Croatia, Finland) to determine if first-line infliximab (FL-IFX) is a more effective treatment to accomplish and sustain remission in comparison with conventional treatment, which is exclusive enteral nutrition (EEN) and oral prednisolone. The researchers recruited a total of 100 patients between the ages of 3 and 17 years with newly diagnosed untreated CD for the trial between April 7, 2015, and November 19, 2018. They assigned 50 participants to the FL-IFX group and gave 5 infusions of IFX 5 mg/kg at weeks 0, 2, 6, 14, and 22. They assigned the other 50 participants to the conventional group and gave them EEN or oral prednisolone (1 mg/kg; maximum 40 mg).
The researchers found that at week 10, a higher percentage of participants in the FL-IFX group than in the conventional group attained clinical (59% vs 34%; P =.021) and endoscopic (59% vs 17%; P =.001) remission. By week 52, 41% of patients treated with FL-IFX were in clinical remission on azathioprine monotherapy and did not need treatment escalation vs 15% of the patients in the conventional group.
Although there were limitations in the trial, such as possible performance bias, missing endoscopic results for some patients, and differences in the length of therapy between the 2 groups, the researchers determined that FL-IFX produces more desirable outcomes for pediatric patients with moderate to severe CD when compared with conventional treatment methods. These findings suggest that more research and follow-up on IFX is warranted to determine the appropriate length of treatment and who will benefit most from treatment.
Jongsma, MME, Aardoom MA, Cozijnsen MA, et al. First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn’s disease: an open-label multicentre randomized controlled trial. Gut. Published online December 31, 2020. doi:10.1136/gutjnl-2020-322339