Treatment‐based risk stratification of infections in inflammatory bowel disease: A comparison between anti‐tumor necrosis factor‐α and nonbiological exposure in real‐world setting.

Background and Aim: Infective issues about anti‐tumor necrosis factor (TNF)‐α agents in inflammatory bowel disease (IBD) remain controversial, especially when compared with nonbiological treatments. This study aimed to evaluate the incidence and prevalence of several infections in anti‐TNF‐α‐exposed patients compared with nonbiological treatments. Methods: All naïve IBD subjects treated with anti‐TNF‐α and matched nonbiologic‐exposed patients were included. Results: Among 3453 patients in the database, 288 anti‐TNF‐α‐exposed subjects and 288 nonbiologic‐exposed IBD controls met inclusion criteria. Fifty‐eight infections (20.1%) occurred during anti‐TNF‐α treatment versus 23 (8%) in the matched group (odds ratio [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‐TNF‐α versus mesalamine/sulfasalazine (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‐TNF‐α‐exposed versus 0.38/100 patient‐years in nonexposed subjects (IR 3.44, P = 0.002), without significant difference between anti‐TNF‐α and azathioprine/6‐mercaptopurine/methotrexate (1.3 vs 3.03/100 patient‐years, IR 0.43, P = 0.1). Predictors of infections in anti‐TNF‐α‐exposed patients were concomitant use of systemic steroids (OR 1.9, P = 0.02) or azathioprine (OR 2.6, P = 0.01) and a body mass index < 18.5 at time of infection (OR 2.2, P = 0.01). Conclusions: The risk of developing infections during anti‐TNF‐α therapy remains high, although not dissimilar to that found for other immunosuppressants, while concomitant immunosuppression and malnutrition appear the most important causes of infection. [ABSTRACT FROM AUTHOR]