Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease.
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.
Mackey
Ann Corken
AC
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA.
Green
Lanh
L
Liang
Li-Ching
LC
Dinndorf
Patricia
P
Avigan
Mark
M
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*
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D000069285:Infliximab