[Tacrolimus in the treatment of refractory moderate-to-severe inflammatory bowel disease].

INTRODUCTION: The primary endpoint of this study was to evaluate the efficacy of oral tacrolimus in patients with active moderate-to-severe luminal IBD, mainly those refractory to steroids. Secondary endpoints were surgery requirements during follow-up, the percentage of patients achieving steroid withdrawal, and treatment safety.

PATIENTS AND METHOD: Nineteen patients were included. The main indication for tacrolimus therapy was steroid resistance. The mean duration of treatment was 11 (range 3- 13) and 15 (range 4-44) months in patients with UC and CD, respectively. Remission was evaluated at weeks 4, 8 and 24 from the start of treatment, using the Harvey-Bradshaw index and the Truelove-Witts criteria for CD and UC patients, respectively, and acute- phase reactants (Serum erythrocyte sedimentation rate and C-reactive protein). Steroid withdrawal, need for surgery, and previous and concomitant medication were also evaluated.

RESULTS: Overall, 47%, 66% and 41% of the patients were in complete remission at weeks 4, 8 and 24, respectively. Steroid withdrawal was achieved in 50% of the patients. Among patients who could not undergo complete steroid withdrawal, steroid therapy was reduced to a mean prednisone dose of 12.5 mg /day (range 10-15 mg). Surgery was required in 16% (mean follow-up of 38 months). Adverse effects occurred in 63% patients, who improved with dose reduction; none of the patients required tacrolimus withdrawal.

CONCLUSIONS: Oral tacrolimus could be a safe, effective and useful option in patients with refractory IBD.