Cure8 news brief
Early use of infliximab plus an immunomodulator was associated with better 5-year outcomes versus starting with conventional step-up therapy, which could influence treatment choices for newly diagnosed Crohn’s patients.
Newly diagnosed adults with Crohn’s disease, patients considering biologic therapy, clinicians who manage IBD, and researchers studying disease-modifying strategies.
This analysis followed participants originally randomized to 48 weeks of either top-down infliximab plus an immunomodulator or step-up care, then returned to local standard care. Investigators used intention-to-treat analyses and time-to-event methods (Kaplan–Meier and Cox models) to compare outcomes over a median ~5-year follow-up.
The study found substantially fewer disease-related abdominal operations and hospital admissions in the top-down group, and a longer time to surgery or disease progression versus step-up. Serious infections and malignancies were reported as not different between groups in the published follow-up.
This report is a follow-up analysis of the PROFILE randomized trial published in Lancet Gastroenterology & Hepatology. It suggests early anti-TNF plus immunomodulator therapy may alter long-term disease course, but treatment decisions should still be individualized.
This is a long-term follow-up of a randomized trial where initial treatment was given for 48 weeks and afterwards patients returned to usual care; the follow-up analysis used registry/record data. Individual risks, preferences, and local standards of care still guide treatment decisions.
Review the original publication for the complete reporting, methods, and context.
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