Long-Term Outcome of Early Combined Immunosuppression Versus Conventional Management in Newly Diagnosed Crohn's Disease

Long term outcomes of early combined immunosuppression (top-down) compared to conventional management (step-up) in recently diagnosed Crohn's disease (CD) are unknown. We aimed to investigate long-term outcomes of participants of the Step-up/Top-down-trial. Trial participants' medical records were reviewed retrospectively. For 16 semesters following the 2-year trial, we recorded: clinical activity, medication use, flares, hospitalization, surgery and fistulas. Colonoscopy reports were scored as: endoscopic remission, aphthous/small ulcers or large ulcers. Primary endpoint was the proportion of semesters in remission. Data were available from 119/133 patients (step-up n=60). During a median follow-up of 8 years, clinical remission rates were similar (70% vs. 73% [p=0.85] in step-up and top-down patients, respectively). A shorter time to flare was observed in step-up patients (median 5 vs. 9 semesters, p=0.01). Cumulatively, 62% of step-up patients used corticosteroids compared to 41% of top-down patients (p=0.02). Anti-TNF use was higher in the step-up group (73% vs. 54%, p=0.04). No differences were found in to time to CD-hospitalization (respectively 13 vs. 14 semesters, p=0.30), new fistula (14 vs. 15 semesters, p=0.20) or CD-surgery (14 vs. 15 semesters, p=0.25). Mucosal healing 2 years after treatment was associated with a reduced anti-TNF use, but not with differences in other long-term outcomes. Endoscopic remission occurred at similar rates between groups. Top-down treatment did not result in increased clinical remission during long-term follow-up, compared to step-up treatment. However, lower relapse rates and a lower use of anti-TNF agents and corticosteroids was observed. No difference was found in rates of endoscopic remission, hospitalization, surgery, or new fistulas