Although severe infectious complications are rare, it is important to properly screen patients for predisposing conditions before beginning treatment with infliximab. We assessed immunity markers that might provide prognostic value for the development of infection in Crohn's disease patients after treatment with infliximab. In a prospective study, 34 fistulizing Crohn's disease patients (mean age 37 years) were studied. Patients were scheduled to receive three infusions of infliximab (5 mg/kg) at weeks 0, 2, and 6. Immunologic studies: Serum immunoglobulin (IgG, IgA, IgM), IgG-subclasses, and complement (C3, C4, factor B) determined by nephelometry; CD3+, CD3+CD4+, CD3+CD8+, CD19+, and CD56+CD3- lymphocyte subsets performed by flow cytometry. During a mean follow-up of 56 months, 1 patient had disseminated tuberculosis and 2 patients had severe bacterial infections. The presence of infection was associated with significantly higher IgM (246 vs. 121 mg/dL; Mann-Whitney test, P = 0.01), lower C3 (64 vs. 118, P = 0.02), lower C4 concentrations (12 vs. 25, P = 0.02), and with decreased levels of CD19 B cells (47 vs. 290, P = 0.03) in the baseline study. Further prospective studies in a larger number of patients are suggested to examine whether early monitoring of immunocompetence might help to identify the risk of infection in patients treated with infliximab.