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INFLIXIMAB USE IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND THE RISK OF HOSPITALIZED CLOSTRIDIUM DIFFICILE INFECTION
S Schneeweiss, DH Solomon, J Korzenik, C Canning, B Bressler
BACKGROUND: The association between infliximab use and Clostridium difficile infection is unknown in patients with Inflammatory Bowel Disease (IBD).
OBJECTIVES: We sought to assess the association between the use of infliximab, systemic corticosteroid use, or immunosuppressant use and the risk for hospitalized Clostridium difficile infection among patients with IBD.
METHODS: The study cohort was drawn from a population-based linked health care utilization databases covering the entire province of British Columbia. We identified patients 18 years and older who had five recorded diagnoses of IBD (Crohn’s, ICD 555.x; colitis, ICD 556.x) between 1996 and 2005. 11,479 patients entered the cohort at their fifth recorded diagnosis and were required to be free of cancer or HIV/AIDS. We compared the effect of initiation of infliximab therapy or systemic glucocorticoid therapy with the initiation of immunosuppressive agents (MTX/Azathioprine/6-MP). Primary outcome was first hospitalized Clostridium difficile infection.
RESULTS: We identified 16,699 new treatment episodes with either of the three drug classes and observed a total of 101 hospitalized Clostridium difficile infection. Glucocorticoid use and its combination with immunosuppressive agents, more than doubles the risk of hospitalized Clostridium difficile infection compared with immunosuppressive agents (RR=2.3; 1.3, 4.2, RR=2.3; 1.3, 4.1 respectively), independent of prior infections, disease activity and other drug use. No hospitalized Clostridium difficile infections occurred in patients only treated with infliximab despite 630 patients years of use. The combination of infliximab and glucocorticoid agent increased the risk of hospitalized Clostridium difficile infections (RR=1.9; 0.7, 4.8).
CONCLUSIONS: In a large cohort of patients with IBD, initiation of corticosteroids alone and in combination with infliximab or immunosuppressant medications were associated with an increased risk of hospitalized Clostridium difficile infection compared with immunosuppressant therapy. No patients treated with infliximab alone developed hospitalized Clostridium difficile infection in this cohort.