Occurrence of adverse events among patients with inflammatory bowel disease in the HealthCore Integrated Research Database

Abstract

Objectives:

Inflammatory bowel disease (IBD) is a chronic condition commonly requiring lifelong care. Both IBD and IBD-related treatments can cause significant morbidity, and it is often difficult to differentiate their relative etiologic contribution to adverse events (AEs). The objectives of this study were to assess the rates of select AEs among patients with IBD as a function of disease severity and of the use of anti-tumor necrosis factor alpha (anti-TNFα) medications.

Methods:

We conducted a retrospective cohort study of IBD patients in the HealthCore Integrated Research Database (HIRD^TM) between January 2004 and January 2011 to determine rates of AEs in patients with mild and moderate to severe IBD. Key study endpoints were select prespecified malignant neoplasms, infections, and other AEs of interest.

Results:

A total of 33,386 IBD patients (52.7% ulcerative colitis; 47.3% Crohn's disease) met the inclusion criteria, and 60% had been followed for ≥1 year. Patients with moderate to severe IBD had increased rates of infections, lymphatic and digestive tract cancers, gastrointestinal (GI) perforations, and myocardial infarctions versus patients with mild IBD. Patients with IBD who used anti-TNFα therapies during the study had increased incidence of many types of infections, certain GI cancers (including rectal and anal cancer), intestinal perforations, and kidney stones compared with patients who had never used anti-TNFα therapies.

Conclusions:

Results from this large US cohort provide descriptive information on AE rates in a population of IBD patients undergoing routine care, estimating background incidence rates of AEs that are not readily available in the published literature. Our study findings may be limited owing to a lack of generalizability and potential for misclassification due to reliance on medical diagnosis and treatment and procedure codes to identify disease, comorbidities, and treatments. Further research and validation of our findings in other populations and databases are needed.

Keywords: :

• Adverse events (AEs)
• Crohn’s disease (CD)
• Ulcerative colitis (UC)

Transparency

Declaration of funding

This work was funded by Takeda Pharmaceuticals International Company, which was responsible for the design of the study and writing the manuscript.

Author contributions: M.E.M. – study design, data analysis/interpretation, manuscript drafting, and review of the manuscript for important intellectual content; S.L., T.L., A.P., G.F., and J.P. – study design, data analysis/interpretation, and review of the manuscript for important intellectual content; C.H., D.E., and Y.Z. – data collection/acquisition, data analysis/interpretation, and review of the manuscript for important intellectual content; I.F. – study design, data analysis/interpretation, and review of the manuscript for important intellectual content.

Declaration of financial/other relationships

M.E.M., T.L., and J.P. have disclosed that they are employees of Takeda Pharmaceuticals International Company (Takeda Boston). I.F. has disclosed that he is an employee of Takeda Pharmaceuticals International Company (Takeda Boston) with an equity interest in Takeda. S.L., C.H., D.E., and Y.Z. have disclosed that they are employees of HealthCore Inc., which received payment from Takeda Pharmaceuticals International Company for the conduct of the study. A.P. has disclosed that he is an employee of Takeda Pharmaceuticals International, Inc. G.F. has disclosed that he is an employee of United BioSource Corporation, which received consulting fees from Takeda Pharmaceuticals International Company.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing assistance was provided by MedLogix Communications, LLC, and supported by Takeda Pharmaceuticals International, Inc.

Previous presentations: Content in this manuscript has previously been presented as congress posters at Digestive Disease Week, 19–22 May 2012, San Diego, CA, with abstracts published in a supplement to Gastroenterology 2012;142(5 Suppl 1):S663-4.