Malignancy in Patients with Crohnʼs Disease: Data from the TREAT™ Registry with More Than 5 Years of Follow-up: 1096

Purpose: The association between malignancy and anti-tumor necrosis factor (TNF) therapy remains under investigation. Methods: We prospectively evaluated the incidence of malignancy in the large-scale, observational TREAT Registry, which examines the long-term outcomes of various treatments, including infliximab, used in the management of Crohn's disease (CD) in community-based and academic practice settings in North America. The influences of baseline patient (pt), disease characteristics and medication use were assessed via multivariate regression analysis and generation of hazard ratios (HRs). Standardized incidence ratios (SIRs) and exact 95% confidence intervals (CIs) were determined by dividing the number of patients with malignancies observed (in TREAT) with expected number (for the general U.S. population) using the Surveillance, Epidemiology End Results [SEER] 2009 database. Results: As of February 23, 2010, 6,273 pts were enrolled: 3,764 received infliximab and 2,509 received other-treatments-only. Incidences of malignancies were similar between infliximab-treated pts and pts receiving other-treatments-only within the categories of hematologic malignancies, lymphoma, nonmelanoma skin cancer, and malignant solid tumors (Table 1). Baseline age, disease duration, smoking, and immunomodulator therapy, but not infliximab therapy were significant predictors of malignancy (Table 2). Results of comparisons between the TREAT Registry and SEER database yielded 95% CIs containing 1 for all categories of malignancy assessed, indicating no significant difference, with the exception of breast cancer and lymphoma (Table 1). Breast cancer was less common in TREAT than SEER, and for lymphoma, the SIR was approximately twice that of the background population in both the infliximabtreated and other-treatments-only cohorts.Table: Table. Malignancies in TREAT: Comparison versus SEER databaseTable: Table. Malignancies in TREAT: effect of risk factorsConclusion: Infliximab did not significantly affect the risk of malignancies; immunomodulator use, age, duration of disease and smoking independently predicted time to first malignancy. Consistent with reports in the literature, CD patients, independent of infliximab treatment, appear to have a higher lymphoma risk than the general U.S. population. Disclosure: GR Lichtenstein: Investigator, Centocor Research and Development, Inc.; B Feagan: Investigator, Centocor Research and Development, Inc.; RD Cohen: Investigator, Centocor Research and Development, Inc.; BA Salzberg: Investigator, Centocor Research and Development, Inc.; RH Diamond: Employee, Centocor Ortho Biotech Services, LLC; W Langholff: Consultant, Centocor Research and Development, Inc.; A Londhe: Employee, Johnson & Johnson PRD.; WJ Sandborn: Investigator, Centocor Research and Development, Inc. This research was supported by an industry grant from This study was sponsored by Centocor Research and Development, Inc.