Bottom line: Hepatosplenic T-cell lymphoma (HSTL) is a very rare, but lethal, cancer of white blood cells that has been reported primarily in adolescents and young adults treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as immunomodulators.
Summary: FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine.
Infliximab, Warnings. In: DynaMed.
Most reported cases have occurred in young adults treated for Crohn’s disease or ulcerative colitis with a combination of TNF blocker and thiopurine analogs (azathioprine or mercaptopurine).
Clin Gastroenterol Hepatol. 2011 Jan;9(1):36-41.e1. doi: 10.1016/j.cgh.2010.09.016. Epub 2010 Oct 1. A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease. Kotlyar DS, et al.
36 patients were identified through searching databases of published literature and FDA adverse event reporting systems. Table 1 summarizes characteristics of patients, including factors related to type of IBD (predominantly CD), sex (29 of the 31 patients for whom sex is known are males), type of agent, and duration of therapy.