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P396. Rates of infections in patients with inflammatory bowel disease receiving biological drugs

V. Rodil1, M.L. De Castro2, V. Hernández3, J.R. Pineda3, S. Pereira3, J. Martínez Cadilla3, P. Estévez3, L. Cid3, D. Martínez-Ares3, L. Sanromán3, V. Del Campo4, J.I. Rodríguez Prada3, 1Universitary Hospital, Internal Medicine, Vigo, Spain, 2Universitary Hospital, Gastroenterology, Vigo, Spain, 3Universitary Hospital, Gastroenterology, Vigo, Spain, 4Universitary Hospital, Epidemiology, Vigo, Spain

Background

Tumor necrosis factor (TNF) inhibitors have demonstrated high efficacy in intestinal bowel diseases (IBD) treatment, but the incidence of infections has been reported to be increased with these biological drugs. The aim of this study was to evaluate the safety profile of TNF-alpha inhibitors in patients with IBD in clinical practice.

Methods

IBD patients treated with TNF-alpha inhibitors in a single medical centre were included in an ongoing prospective cohort study. Since 2001 to 2011 we have reviewed their medical reports and abstracted for demographic features, clinical and infectious events defining severe events as those requiring specific treatment, hospitalization or death.

Results

A total of 146 patients (59.6% males), mean age 41.7 (18–79) and time from diagnosis 10.4 (7.4) years were analyzed. 112 suffered from Crohn's disease (76.7%) and 34 from ulcerative colitis. They received 188 courses of TNF alpha inhibitors: 1.3 per patient with range (1–6): 76% received infliximab, 39.7% adalimumab, 0.7% certolizumab and 1.4% etanercept in ordinary doses. One hundred twenty-three subjects were on concomitant immunosuppressive drugs (84.2%) and 88 used corticosteroids (60.3%) in 166 courses. One hundred and thirteen patients were receiving biological drugs al the end of 2011.Twenty-four infections were recorded in 13 patients and 19 were considered as severe: 10 affecting lower respiratory tract (41.7%), 3 urinary tract (12.5%), 3 skin and eyes. Five patients had tuberculosis, requiring hospitalization and resulting in one death. The crude rate of infection was 81.9 events/1000 persons-years (94.7 infliximab, 47.8 adalimumab respectively) and the crude rate for tuberculosis was 17.1 events/ 1000 persons-years, being much higher than the published 0.35 events/1000 persons-years for 25–60-year subjects in our medical area. There were no significant differences relating to gender, type of IBD, time from diagnosis, biological drugs or other therapies administered concomitantly. Nevertheless older age was significantly associated with an increased risk of infection (p = 0.024) and tuberculosis (p = 0.003).

Conclusion

The rate of tuberculosis infection in IBD patients treated with TNF inhibitor drugs are much higher compared to general population while the rate of infection was similar to other non IBD patients on this therapy.

Age was the only factor associated to risk of infection ad tuberculosis in these patients.