P386 Long-term evolution after anti-TNF discontinuation in patients with inflammatory bowel disease (IBD): A multicentre study

Abstract

Abstract Background (1) To assess the risk of relapse at long-term after anti-TNF discontinuation, (2) to identify the factors associated with relapse, (3) to calculate the response rate to re-treatment with the same anti-TNF, (4) to evaluate the safety of re-treatment with these drugs, and (5) to investigate the rate of complications of patients that relapsed. Methods A retrospective, observational, multicentre study conducted at 39 Spanish centres. Crohn’s disease or ulcerative colitis patients who had been treated with anti-TNFs and in whom these drugs had been withdrawn after achieving clinical remission, were included. Follow-up time after anti-TNF discontinuation was at least 6 months. Results Six hundred and thirty-seven patients were included (53% women, mean age 42, 68% Crohn’s disease). The reasons for discontinuation were: 74% elective decision, 19% adverse events, and 7% remission after top-down strategy. The median follow-up time was 60 months. In patients who relapsed, the median time to relapse after anti-TNF discontinuation was 24 months. The cumulative incidence of relapse was 54% (50–58%): 17% at 1 year, 28% at 2, 34% at 3, and 45% at 5 years after anti-TNF withdrawal. The incidence rate of relapse was 11% per patient-year (10–12%). At the time of anti-TNF discontinuation, endoscopy was performed in 48% of patients; of these, 88% had a normal endoscopy and 9% had mild activity. 68% of patients maintained immunomodulators (IMMs) after discontinuing the anti-TNF. In the multivariate analysis, older age at diagnosis (HR = 0.99; 95% CI = 0.98–0.99, p = 0.003) and the maintenance of IMMs after anti-TNF discontinuation (HR = 0.53; 95% CI = 0.42–0.66, p < 0.0001) were associated with a lower risk of relapse. After relapse, 49% of patients were re-treated with the same anti-TNF, 47% received another drug, and 4% were operated on. Of patients who restarted the same anti-TNF, 79% (70–86%) achieved remission. After re-treatment, 11% presented adverse events, all mild. Of the 48 patients who did not respond after anti-TNF re-treatment, 41% (26–57%) achieved remission with other therapies, and 21% of these patients relapsed at the end of follow-up. Of the 161 patients who started other treatment after relapse, 62% (54–70%) achieved remission with the new treatment, and 30% of these patients relapsed. Conclusion The incidence rate of relapse after anti-TNF discontinuation in IBD Patients who were in remission was 11% per patient-year, and 45% relapsed at 5 years. Older age at diagnosis and maintenance treatment with IMMs were associated with a lower risk of relapse. Re-treatment of relapse with the same anti-TNF was effective and safe. Less than half of the patients who did not respond after re-treatment achieved remission with other therapies.