In the small randomized study, 48 patients with Crohn’s disease and draining perianal or enterocutaneous fistulae were treated for 10 weeks with oral tacrolimus at 0.2 mg/kg per day or placebo.
Fistula improvement was seen in 43% of tacrolimus-treated patients and 8% of placebo-treated patients (P = .004), while remission was seen in 10% and 8% of those groups, respectively (P = .86), according to published data on the trial.
“[Tacrolimus] showed a nice improvement in response rates, but very similar remission rates,” Dr. Osterman said, “but it does represent an option for us, for our patients.”
Dr. Osterman reported grant/research support from UCB and serving as a consultant for AbbVie, Janssen, Lycera, Merck, Pfizer, Takeda, and UCB.
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