A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn's disease (PROFILE): a multicentre, open-label randomised controlled trial.

Publication Date: 2024 May

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Nurulamin M Noor; James C Lee; Simon Bond; Francis Dowling; Biljana Brezina; Kamal V Patel; Tariq Ahmad; Paul J Banim; James W Berrill; Rachel Cooney; Juan De La Revilla Negro; Shanika de Silva; Shahida Din; Dharmaraj Durai; John N Gordon; Peter M Irving; Matthew Johnson; Alexandra J Kent; Klaartje B Kok; Gordon W Moran; Craig Mowat; Pritash Patel; Chris S Probert; Tim Raine; Rebecca Saich; Abigail Seward; Dan Sharpstone; Melissa A Smith; Sreedhar Subramanian; Sara S Upponi; Alan Wiles; Horace R T Williams; Gijs R van den Brink; Séverine Vermeire; Vipul Jairath; Geert R D'Haens; Eoin F McKinney; Paul A Lyons; James O Lindsay; Nicholas A Kennedy; Kenneth G C Smith; Miles Parkes



Management strategies and clinical outcomes vary substantially in patients newly diagnosed with Crohn's disease. We evaluated the use of a putative prognostic biomarker to guide therapy by assessing outcomes in patients randomised to either top-down (ie, early combined immunosuppression with infliximab and immunomodulator) or accelerated step-up (conventional) treatment strategies.


The lancet. Gastroenterology & hepatology

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Randomized Controlled Trial



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