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GASTROENTEROLOGY

Meta-Analysis of Risk of Malignancy with Immunosuppressive Drugs in Inflammatory Bowel Disease

at time of writing, Student, Graduate School of Pharmaceutical Sciences, Meiji Pharmaceutical University, Tokyo, Japan; now, Hospital Pharmacist, Department of Pharmacy, Hatsudai Rehabilitation Hospital, Tokyo

Keiko Ohno, PhD

Assistant Professor, Department of Medication Use Analysis and Clinical Research, Meiji Pharmaceutical University

Ryuichi Ogawa, MS

Research Associate, Department of Pharmacotherapy, Meiji Pharmaceutical University

Masayuki Hashiguchi, PhD

at time of writing, Assistant Professor, Department of Medication Use Analysis and Clinical Research, Meiji Pharmaceutical University; now, Associate Professor, Division for Evaluation and Analysis of Drug Information, Center of Clinical Pharmacy and Clinical Sciences, School of Pharmaceutical Sciences, Kitasato University, Tokyo

Hirotoshi Echizen, MD PhD

Professor, Department of Pharmacotherapy, Meiji Pharmaceutical University

Hiroyasu Ogata, PhD

Professor, Department of Biopharmaceutics, Meiji Pharmaceutical University

Reprints: Dr. Ohno, Department of Medication Use Analysis and Clinical Research, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan, fax 81-424-95-8459, k-kato{at}mypharm.ac.jp

BACKGROUND: There is a concern as to whether long-term administration of immunosuppressants in patients with inflammatory bowel disease (IBD) would increase the risk of malignancy.

OBJECTIVE: To compare the risks of developing malignancy between patients with IBD treated with immunosuppressive agents and patients with IBD not receiving these agents.

METHODS: A systematic literature review was conducted, and a meta-analysis was performed on data retrieved from cohort studies that followed patients with IBD who received immunosuppressive agents for more than a year and documented the incidence of newly developed malignancy. An electronic search was conducted using MEDLINE (1966–September 2006), the Cochrane Library (issue 3, 2006), and Japana Centra Revuo Medicina (1981–September 2006). Medical subject headings used in the searches were azathioprine, 6-mercaptopurine, cyclosporine, methotrexate, tacrolimus, inflammatory bowel disease, and neoplasms. We imposed no language limitation in the searches. Additionally, a manual search of reference listings from all articles retrieved from the electronic databases was performed. Using data obtained from control groups or population-based studies, the incidence of newly developed malignancy in patients with IBD treated with immunosuppressive agents was compared with that of patients with IBD who were not receiving immunosuppressive agents. Statistical analysis for the change in risk of developing malignancy was performed using the weighted mean difference (WMD) normalized to per person-year and its 95% confidence interval.

RESULTS: Nine cohort studies met the inclusion criteria for this meta-analysis. Analysis of these studies showed no discernible difference (WMD –0.3 x 10^-3/person-year; 95% CI –1.2 x 10^-3 to 0.7 x 10^-3) in the incidence of any kind of malignancy in patients with IBD who received immunosuppressants compared with those who did not receive immunosuppressants. No significant difference in WMD was observed when the data from patients with either Crohn's disease (CD) or ulcerative colitis (UC) were analyzed separately.

CONCLUSIONS: Our findings suggest that the administration of immunosuppressive agents in patients with either CD or UC probably does not confer a significantly increased risk of malignancy compared with patients with IBD who are not receiving these agents.

Key Words: azathioprine, inflammatory bowel disease, malignancy, 6-mercaptopurine

Published Online, January 2, 2007. www.theannals.com, DOI 10.1345/aph.1H219

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