Between 29 December 2017 and 5 January 2022, in a multicentre, open-label, biomarker-stratified, interventional clinical trial (PROFILE), 386 adult patients with newly diagnosed active Crohn’s disease were randomly assigned to two groups: top-down (early combined immunosuppression with infliximab (a TNF monoclonal antibody) and an immunomodulator) or accelerated step-up (conventional) treatment.

The patients (46% women and 54% men) were stratified by a putative prognostic blood-based biomarker derived from T cell transcriptional signatures and severity and location of inflammation via endoscopy (mild, moderate or severe, and colonic or other, respectively).