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

Abstract

The long-term outcome of patients after antitumour necrosis factor alpha (anti-TNF) discontinuation is not well known. To assess the risk of relapse in the long-term after anti-TNF discontinuation. 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disease (EVODIS) study (Crohn's disease or ulcerative colitis patients treated with anti-TNFs in whom these drugs were withdrawn after achieving clinical remission) based in the same cohort of patients whose outcome was updated.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. This was an observational, retrospective, multicenter study. A total of 1055 patients were included. The median follow-up time was 34months. 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 2years, 38% at 3years, 44% at 4years and 48% at 5years 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. 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.