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


METHODS
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.
Olmedo Martín
Raúl
R
Servicio de Aparato Digestivo, Hospital Regional Universitario Carlos Haya, Málaga, Spain. raulolmedo1@wanadoo.es
Jiménez Pérez
Miguel
M
Marín García
David
D
Amo Trillo
Víctor
V
Pérez-Olivares Jaén
Juan
J
Romero Blasco
Bartolomé
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016559:Tacrolimus / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D016559:Tacrolimus