Dr Ailsa Hart and colleagues from England evaluated the efficacy of topical tacrolimus in treating perianal Crohn's disease.
The research team randomized 19 patients to topical tacrolimus 1 mg/g or placebo for 12 weeks.
Of these patients, 7 presented with ulcerating, and 12 with fistulizing, perianal Crohn's disease.
The researchers reported that 16 patients had been on, or were currently taking, azathioprine/mercaptopurine, and 6 had received infliximab.
|3 of 4 patients improved with topical tacrolimus|
|Inflammatory Bowel Disease|
The team's primary outcome in ulcerating disease was global improvement in perianal/anal lesions, as assessed by the attending physician.
The team measured the reduction by 50% of actively draining fistulas on 2 consecutive visits.
Blood tacrolimus levels and adverse events were also assessed.
The researchers found that 3 of 4 patients treated with topical tacrolimus for ulcerating disease improved compared with none of 3 in the placebo group.
The team noted that complete healing was not achieved.
In fistulizing disease, the researchers observed that topical tacrolimus was not beneficial.
The researchers observed that 2 tacrolimus-treated patients developed perianal abscesses.
Of these, 1 patients developed perianal abscesses after improvement in fistula drainage.
The team observed that adverse events were otherwise infrequent and mild.
Whole blood tacrolimus levels were detectable in only 2 patients, and were low.
Dr Hart's team concluded, “These preliminary data suggest that topical tacrolimus is effective and safe in the treatment of perianal or anal ulcerating Crohn's disease.”
“This therapy is unlikely to be beneficial in fistulizing perianal Crohn's disease, although a larger study is required to confirm this.”