Abstract
OBJECTIVE: To assess methods of disease reassessment and rates of treatment withdrawal in patients with Crohn's disease (CD) treated with biologics and to report retrospective risk stratification for treatment withdrawal as suggested by the STORI trial in the context of this cohort. DESIGN: A retrospective observational cohort study of all patients with CD treated with antitumour necrosis factor (anti-TNF) therapy for >12 months in 2011. SETTING: Tertiary care. PATIENTS: Patients with CD treated with anti-TNF therapy. MAIN OUTCOME MEASURES: Method and outcome of reassessment and whether patient was withdrawn from therapy; also, whether patients met low-risk criteria for withdrawal as identified by the STORI trial, and outcome of those meeting low-risk criteria. RESULTS: 73 patients (infliximab n=48, adalimumab n=25) underwent disease reassessment. Nine patients were deemed to have achieved remission and were withdrawn from treatment: 6 (67%) maintained remission at 12 months, three patients relapsed and were successfully retreated. 52 patients had sufficient data available for STORI criteria to be applied retrospectively. 37% (19/52) fulfilled low-risk criteria for withdrawal-of these, 26% (5/19) were withdrawn from anti-TNF therapy and three had sustained clinical remission at 1 year. Reasons for non-withdrawal included ongoing endoscopic activity (n=8), radiological activity (n=2) and clinical concern due to previous disease behaviour (n=4). CONCLUSIONS: Relatively few patients were deemed in sufficient depth of remission to warrant a trial of withdrawal of anti-TNF therapy. Many patients were not withdrawn, despite meeting STORI low-risk criteria, due to ongoing disease activity highlighting the limitations of applying such criteria in a 'real world' setting.