Background: The use of immunomodulatory agents has changed the management of inflammatory bowel disease. Immunosuppressive drugs (mainly thiopurines) and biological treatments (mainly monoclonal antibodies against TNFalpha) are currently most frequently and earlier used. The recent report of new cases of the rare and almost always fatal hepatosplenic T-cell lymphoma in young patients on combined therapy with azathioprine/6-mercaptopurine and infliximab suggests that the optimal strategies for reducing increased risk of side-effects need to be urgently assessed.
Patients and method: We report the effects of stopping immunosupressants in four Crohn's disease patients previously treated with azathioprine and infliximab for 6-12 months as combined therapy. The appearance of infusion reactions due to immunogenicity and the loss of efficacy of infliximab are evaluated.
Results: No adverse events attributable to immunosuppression cessation or changes in infliximab efficacy have been noted during a 6-month evaluation period.
Conclusions: Stopping immunosuppressant therapy in Crohn's patients with a previous good response to combination therapy (azathioprine and infliximab) does not result in an increased risk of adverse events or loss of infliximab efficacy. Our results must be confirmed in larger and longer studies. Until the pathogenic role of this combined therapy in the incidence of hepatosplenic T-cell lymphoma is clearly defined, we consider that monotherapy with infliximab after a period on combined treatment is a safe and effective strategy.