Clinical outcome after anti‐tumour necrosis factor therapy discontinuation in 1000 patients with inflammatory bowel disease: the EVODIS long‐term study

Summary Background The long‐term outcome of patients after antitumour necrosis factor alpha (anti‐TNF) discontinuation is not well known. Aims To assess the risk of relapse in the long‐term after anti‐TNF discontinuation. Methods This was an extension of the evolution after anti‐TNF discontinuation in patients with inflammatory bowel disease (EVODIS) study (Crohn's disease or ulcerative colitis patients treated with anti‐TNFs in whom these drugs were withdrawn after achieving clinical remission) based in the same cohort of patients whose outcome was updated. Clinical remission was defined as a Harvey–Bradshaw index ≤4 points in Crohn's disease, a partial Mayo score ≤2 in ulcerative colitis and the absence of fistula drainage despite gentle finger compression in perianal disease. Results This was an observational, retrospective, multicenter study. A total of 1055 patients were included. The median follow‐up time was 34 months. The incidence rate of relapse was 12% per patient‐year (95% confidence interval [CI] = 11‐14). The cumulative incidence of relapse was 50% (95% CI = 47‐53): 19% at one year, 31% at 2 years, 38% at 3 years, 44% at 4 years and 48% at 5 years of follow‐up. Of the 60% patients retreated with the same anti‐TNF after relapse, 73% regained remission. Of the 75 patients who did not respond, 48% achieved remission with other therapies. Of the 190 patients who started other therapies after relapse, 62% achieved remission with the new treatment. Conclusions A significant proportion of patients who discontinued the anti‐TNF remained in remission. In case of relapse, retreatment with the same anti‐TNF was usually effective. Approximately half of the patients who did not respond after retreatment achieved remission with other therapies. More than 1000 patients discontinued the anti‐TNF therapy after having achieved clinical remission. Half of them relapsed during follow‐up. After relapse, 60% of the patients restarted the same anti‐TNF, 36% received other therapeutic options, and 4% were operated on. Of the patients who restarted the same anti‐TNF, 73% achieved remission. Of the patients who received other therapeutic options, two‐thirds achieved remission.