Oral tacrolimus long-term therapy in patients with Crohn's disease and steroid resistance

Aim: To report the results of a prospective, open-label, uncontrolled study in 13 patients affected by Crohn's disease with resistance to steroids. Methods: The patients were treated long-term with oral tacrolimus, aiming t o both resolve acute attacks and maintain remission. Tacrolimus was adminis tered at the dose of 0.1-0.2 mg.day/kg and adjusted in order to achieve lev els of 5-10 ng/mL; only mesalazine was continued concomitantly. Steroids an d total parenteral nutrition were tapered when appropriate. Results: Median treatment was 27.3 months. Only one patient dropped out due to adverse events. Crohn's disease activity index score significantly decr eased after 6 months in 11 patients; for 1 year in nine of them, and 7 year s in two of them. The inflammatory bowel disease life-quality questionnaire score significantly increased over the same periods. A marked drop in hosp italizations was recorded. In three out of six patients complete closure of fistulas occurred. Tacrolimus allowed total parenteral nutrition to be wit hdrawn in three out of five patients. Supplementation with low-dose steroid s was required in five patients. Two patients underwent surgery. Conclusions: Tacrolimus therapy appears to be associated with both short- a nd long-term benefits, and may represent a therapeutic option in Crohn's di sease when conventional therapies fail. This study encourages its use in co ntrolled trials.