title: Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease.
abstract: Hepatosplenic T cell lymphoma (HSTCL) are rare cancers ( approximately 100 published cases worldwide) and comprise 5% of peripheral T cell lymphomas. As of October 5, 2006, the FDA's Adverse Event Reporting System has received 8 cases of HSTCL in young patients using infliximab, a tumor necrosis factor-alpha blocking agent, to treat inflammatory bowel disease (6 of the 8 cases had a fatal outcome). All 8 patients were receiving concomitant immunosuppressant therapy (eg, azathioprine, prednisone). It has not been established that infliximab had an exclusive or primary role in the pathogenesis of these HSTCL cases; however, it appears that patients using this product may be at greater risk for developing this rare lymphoma.
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA.
authors.forename: Ann Corken
authors.initials: AC
authors.lastname: Mackey
authors.forename: Lanh
authors.initials: L
authors.lastname: Green
authors.forename: Li-Ching
authors.initials: LC
authors.lastname: Liang
authors.forename: Patricia
authors.initials: P
authors.lastname: Dinndorf
authors.forename: Mark
authors.initials: M
authors.lastname: Avigan
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D002648:Child; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D008113:Liver Neoplasms / Q000139:chemically induced*; D016399:Lymphoma, T-Cell / Q000139:chemically induced*; D008297:Male; D013160:Splenic Neoplasms / Q000139:chemically induced*
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D000069285:Infliximab