P550 Long - term efficacy of Tacrolimus in Inflammatory Bowel Disease: a retrospective pilot study
I. Rodríguez - Lago*1, O. Merino2, Ó. Nantes3, I. Moraleja1, J.L. Cabriada1
1Hospital Galdakao - Usansolo, Gastroenterology Department, Usansolo, Spain, 2Hospital Universitario de Cruces, Gastroenterology Department, Bilbao, Spain, 3Complejo Hospitalario de Navarra, Gastroenterology Department, Pamplona, Spain
Crohn's disease and ulcerative colitis are lifelong conditions marked by multiple periods of inflammatory activity and remission. A significant number of patients suffer a steroid-refractory or dependent disease and require maintenance immunosuppression. The available options in this situation are thiopurines, methotrexate and biologics. However, intolerance and loss of response are not uncommon. Tacrolimus is a macrolide calcineurin inhibitor that is commonly used to prevent kidney and liver transplant rejection. It inhibits the production of interleukin-2 and T lymphocyte activation. There is sparse evidence about the efficacy of Tacrolimus in Inflammatory Bowel Disease (IBD), almost retrospective and uncontrolled. Due to the lack of available data and the potential for drug toxicity, the use of Tacrolimus in the management of refractory IBD is controversial.
This is a retrospective multicentre study conducted in three Spanish IBD Units. The local ethics committee approved the study protocol. A total of 15 patients were included in the study. All the information was obtained from the medical report of each institution. In order to assess the efficacy of Tacrolimus, clinical, analytical and endoscopic variables were included.
A total of 8 patients with Crohn's disease and 7 with ulcerative colitis were included. Most of them suffered from a long-standing disease and were refractory to immunosuppressive therapy. All of them have previously received azathioprine and 69 % biologics. The most common indications for starting Tacrolimus were steroid - dependence and fistulising disease. The drug was maintained at least 12 months in 9 patients (69%). The mean follow up time since the start of the drug was 43.5 ± 21.3 months. Mean drug levels were between 5 - 10 ng/mL. The median PCR levels at baseline were 6.5 mg/dL [2.5 - 12.3]. Complete clinical remission was observed in 5 patients (38 %) and partial clinical response in 4 patients (30 %). Five patients developed adverse events (38 %), none of them were severe. The drug was withdrawn in ten patients during the follow up, mainly due to loss of response and in three subjects because of an adverse event.
This clinical - practice study found steroid - dependence and fistulising disease as the most common indications for the use of Tacrolimus. The treatment showed a relative good clinical efficacy with a reasonable safety profile. This study suggests that Tacrolimus may be included as an option in patients refractory or intolerant to previous therapy, but more data is required to establish the exact role of Tacrolimus in the treatment algorithm of IBD.