Long-term outcomes of top-down therapy versus a conventional step-up strategy in adults newly diagnosed with Crohn's disease: 5-year follow-up of the PROFILE trial.

What To Know

This is a 5-year follow-up (median ~5 years) of the PROFILE randomized trial comparing an early “top-down” strategy (infliximab plus an immunomodulator from diagnosis) versus a conventional step-up approach in adults newly diagnosed with Crohn’s disease.

The analysis used intention-to-treat groups from the original trial and extracted objective outcomes up to 5 years, with Crohn’s-related abdominal surgery as the primary outcome.

Participants originally assigned to top-down therapy had fewer Crohn’s-related abdominal surgeries (6 surgeries in top-down vs 28 in step-up group) and longer time to surgery (adjusted HR 5.23 for step-up vs top-down). Secondary outcomes — hospital admissions and progression to B2/B3 disease behavior — were also more frequent/earlier in the step-up group.

Serious infections and malignancy rates were similar between groups during follow-up. The study authors conclude that early top-down anti-TNF treatment from diagnosis was associated with improved long-term outcomes at 5 years and may be disease-modifying.

The trial was multicentre, open-label, randomized, and completed in the UK; after week 48 participants reverted to local care. This brief is based on the article abstract provided by The Lancet Gastroenterology & Hepatology via Europe PMC and should be read as a summary of that abstract, not a review of the full published paper.