Reenaers C, et al. - This study was performed to elucidate the long-term outcomes of patients with Crohn’s disease (CD) in clinical remission after infliximab treatment was withdrawn. 1/5^th of the patients did not restart infliximab or another biologic agent and did not develop major complications in a long-term follow-up of the stable remission on combined therapy with anti-metabolites (STORI) cohort (7 years). 70% of patients had no failure of the de-escalation strategy (no major complication and no failure of infliximab restart).

• A retrospective analysis was performed of data from the 115 patients involved in the infliximab discontinuation in patients with CD in stable remission on combined therapy with anti-metabolites (STORI) study, conducted at 20 centers in France and Belgium from March 2006 through December 2009.
• The STORI cohort was a prospective analysis of risk and factors associated with relapse following withdrawal of maintenance therapy with infliximab, maintained on anti-metabolites, while in clinical remission.
• Data was gathered from the end of the study until the last available follow-up examination on patient surgeries, new complex perianal lesions (indicating major complications), and need for and outcomes of restarting therapy with infliximab or another biologic agent.
• When a major complication or infliximab restart failure occurred, the de-escalation strategy was considered to have failed.

• In the final analysis, the physicians included data from 102 patients (from 19 of the 20 study centres) from the 115 patients initially admitted.
• The median follow-up time was 7 years.
• 21% of the patients did not restart treatment with infliximab or another biologic agent and did not have a major complication 7 years after infliximab withdrawal (95% CI, 13.1–30.3).
• Treatment failed for 30.1% 6 years after restarting (95% CI, 18.5–42.5) among patients who restarted infliximab.
• Overall, major complications occurred in 18.5% of patients (95% CI, 10.2-26.8) while 70.2% of patients had no failure of the de-escalation strategy (95% CI, 60.2-80.1) at 7 years after stopping infliximab therapy.
• Upper-gastrointestinal location of disease, white blood cell count ≥ 5.0x10⁹/l, and hemoglobin level ≤12.5 g/dl at the time of infliximab withdrawal were the factors independently associated with major complications.
• In the 7 years following infliximab withdrawal, patients with at least 2 of these factors had a more than 40% risk of major complication.