In this study, a team of investigators from North America determined the effectiveness of tacrolimus for the treatment of Crohn’s disease fistulas.
The team performed a randomized, double-blind, placebo-controlled, multicenter clinical trial.
They randomized 48 patients with Crohn’s disease and draining perianal or enterocutaneous fistulas to receive oral tacrolimus (0.2 mg per kg per day), or placebo for 10 weeks.
|43% of tacrolimus-treated patients had fistula improvement.|
The primary outcome measure was fistula improvement. This was defined by closure of 50% of the fistulas and maintenance of closure for at least 4 weeks.
The team set the secondary outcome as fistula remission. This was defined by closure of all fistulas and maintenance of that closure for at least 4 weeks.
The research team found that 43% of tacrolimus-treated patients had fistula improvement, compared with 8% of patients in the placebo group.
However, only 10% of patients in the tacrolimus group had fistula remission, compared with 8% of the placebo group.
The team determined that adverse events associated with tacrolimus, including headache, increased serum creatinine level, insomnia, leg cramps, paresthesias, and tremor, could be managed with dose reduction.
Dr William Sandborn's team concluded, "Oral tacrolimus…is effective for fistula improvement, but not fistula remission, in patients with perianal Crohn’s disease".
"Adverse events associated with tacrolimus can be managed by dose reduction".
"Lower doses of tacrolimus should be evaluated".