Abstract

Abstract Background In the UK, NICE guidance requires an annual review of TNF antagonists with the withdrawal of therapy in patients in confirmed remission. This study assesses the outcome of this practice in patients with Crohn’s disease (CD) and ulcerative colitis (UC) who received infliximab at a large referral centre. The primary outcome is relapse-free survival. Secondary objectives include evaluation of predictors of relapse, and response to subsequent therapy. Methods IBD patients who ceased infliximab due to remission at annual review were identified. Demographics and clinical characteristics were collected from electronic patient records. Disease activity from 3 months prior to cessation and throughout follow-up was recorded; active disease was defined as CRP>10, faecal calprotectin>50, endoscopic activity or radiological activity. Relapse was defined as the aforementioned markers of activity with clinician documentation of relapse. Immunomodulator use, active disease prior to cessation, age at diagnosis and ethnicity were analysed in patients who had completed 6, 12, 18 and 24 months of follow-up. Survival analysis and logistical regression were undertaken with SPSS®. In patients who relapsed, steroid use and future biologic use was evaluated. Analysis was undertaken for total IBD, CD and UC. Results 66 cases were identified (CD:UC = 40:26, F:M =28:38, Asian:Black:Caucasian:Multiracial/Unknown = 13:3:45:5). Median follow-up was 18.1 months (IQR 9.07–41.71). Failure free survival was: all IBD; 14.65 months (IQR 8.38–25.23), CD; 13.08 months (IQR 7.66–25.23) and UC; 14.65 months (IQR 5.91–22.47). Relapse rates of patients who completed follow-up at each time point are presented in Table 1: No predictors of disease relapse were identified at any time point. Thirty-seven patients experienced relapse, of whom 40.5% (15/37) were prescribed steroids, 86.5% (32/37) restarted a biologic and 67.7% (25/37) restarted infliximab. Of those who have completed infliximab induction, 56.5%(13/23) recaptured response to standard dose and a further 13.0% (3/23) required 10mg/kg. Alternative therapy was required in 30.4% (7/23). Conclusion Within 24 months of cessation 73.1% patients relapsed. The majority of these restarted a biologic. However, only 56.5% of patients who restarted infliximab responded to standard dose. With additional costs of newer biologics and morbidity of disease flare and steroid use, routine withdrawal of TNF antagonists should only occur after careful consideration.

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