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* = Presenting author

P565 Maintenance of clinical remission in inflammatory bowel disease patients after discontinuation of anti-TNF agents, an Italian experience

R. Monterubbianesi*1, F. Furfaro2, G. Costantino3, C. Bezzio2, D. Giannarelli4, W. Fries3, G. Maconi2, A. Kohn1

1AO San Camillo Forlianini, Gastroenterology Operative Unit, Rome, Italy, 2Luigi Sacco University Hospital, Department of Gastroenterology and IBD Unit, Milan, Italy, 3University of Messina, Department of Gastroenterology, Messina, Italy, 4Nuovo Regina Elena Hospital, Biostatistic Unit, Rome, Italy

Background

Despite the long experience in the treatment of inflammatory bowel disease (IBD) with anti-TNF agents, we still do not know whether and when to stop the biological treatment in patients that are in clinical remission. Aim: to assess the risk of relapse in an Italian cohort of IBD patients who discontinued anti-TNF therapy because of clinical benefit, and to evaluate if the mucosa healing is associated to a better outcome

Methods

Consecutive patients followed in 3 Italian referral centre for IBD, affected by Crohn’s disease(CD) or ulcerative colitis (UC), and who received infliximab (IFX) or adalimumab (ADA) for a period ≥ 12 months from January 1999 to August 2013 and discontinued the drug because in clinical remission, were included. All patients had an endoscopy performed before and after the treatment with anti-TNF. Demographic, clinical, and endoscopic characteristics of patients were collected. Relapse was defined as need for rescue therapy (corticosteroids or new cycle of anti-TNF) or surgery. All patients had a follow-up > = 12 months.

Results

In total, 126 patients were included: 99 were affected by CD (78.6%) and 27 by UC (21.4%). Median age was 35 yr old (range 15–78 yr). Further, 56% were male. In addition, 108 patients received IFX (85.7%), and 18 ADA (14.3%). Median disease duration at first administration of drug was 84 months. In the CD group, 37% of patients underwent surgery in the past. In the UC group, 54% of patient had a pancolitis or a subtotal colitis. A concomitant treatment with immunosuppressant therapy (ISS) was seen in 65.9% of patients. Mucosal healing was achieved in 77 patients (61.6%). Kaplan–Meier curve showed a cumulative probability of a disease free course at 1 year of 78%. Two years after stopping anti-TNF, 64% of patients were in remission. Probability of relapse after 5 years was 54%. In the univariate analysis, the following variables resulted, which were related to the probability of maintenance clinical remission, gender (male, 0.001), age (> = 35 yr, 0.05), and concomitant immunosuppression (0.02). Mucosa healing was not associated with a better outcome.

Conclusion

In our cohort, composed by IBD patients treated with anti-TNF at least for 1 year who discontinued the treatment because of being in clinical remission, the probability of maintenance clinical benefit at 2 years was 64%. Risk of relapse was more frequent in the first 2 years from withdrawal. Male sex, age older than 35 years, and concomitant immunosuppressant therapy seem to be related to a better outcome, whereas mucosa healing was not associated to a delayed relapse in our cohort. Prospective studies are needed to identify patients with a low risk to relapse.