TREATMENT‐BASED RISK STRATIFICATION OF INFECTIONS IN INFLAMMATORY BOWEL DISEASE: A COMPARISON BETWEEN ANTI‐TNFα AND NON‐BIOLOGIC EXPOSURE IN REAL WORLD SETTING

BACKGROUND AND AIMS Infective issues about anti-TNFα agents in inflammatory bowel disease (IBD) remain controversial, especially when compared with non-biologic treatments. AIM to evaluate the incidence and prevalence of several infections in anti-TNFα-exposed patients compared to non-biologic treatments. METHODS all naive IBD subjects treated with anti-TNFα and matched non-biological-exposed patients were included. RESULTS Among 3453 patients in the database, 288 anti-TNFα-exposed subjects and 288 non-biologic-exposed IBD controls met inclusion criteria. Fifty-eight infections (20.1%) occurred during anti-TNFα treatment vs 23 (8%) in the matched group (OR 2.9, p<0.001) (incidence 5.72 vs 0.96/100 patient-years, incidence ratio (IR) 6, p<0.001). IR was higher for anti-TNFα vs mesalamine/sulphasalazine (IR 40.8, p<0.001), similar to azathioprine/6-mercaptopurine/methotrexate (IR 0.78, p=0.32) and lower than corticosteroids (IR 0.05, p<0.001). The incidence rate of serious infections was 1.3 in the anti-TNFα-exposed vs 0.38/100 patient-years in non-exposed subjects (IR 3.44, p=0.002), without significant difference between anti-TNFα and azathioprine/6-mercaptopurine/methotrexate (1.3 vs 3.03/100 patient-years, IR 0.43, p=0.1). Predictors of infections in anti-TNFα-exposed patients were concomitant use of systemic steroids (OR 1.9, p=0.02) or azathioprine (OR 2.6, p=0.01) and a BMI<18.5 at time of infection (OR 2.2, p=0.01). CONCLUSIONS The risk of developing infections during anti-TNFα therapy remains high, although not dissimilar to that found for other immunosuppressants, while concomitant immunosuppression and malnutrition appear the most important causes of infection.