Topical tacrolimus clears peristomal PG

February 21, 2005

Local treatment with the topical immunomodulator tacrolimus 0.1 percent ointment (Protopic, Fujisawa) may be a useful adjunct in the management of pyoderma gangrenosum (PG), and can some times be used successfully as monotherapy, perhaps particularly for the treatment of peristomal disease, said David Fivenson, M.D.

Local treatment with the topical immunomodulator tacrolimus 0.1 percent ointment (Protopic, Fujisawa) may be a useful adjunct in the management of pyoderma gangrenosum (PG), and can some times be used successfully as monotherapy, perhaps particularly for the treatment of peristomal disease, said David Fivenson, M.D.

Dr. Fivenson and colleagues reported results from an open-label study in which they treated five adult patients with PG lesions using topical tacrolimus under occlusion. The patients all had clinically uninfected ulcers measuring 1 cm2 or larger with a surrounding area of erythema of 3 cm2 or larger. Mean duration of disease prior to enrollment was 16.2 months, and previous treatments were discontinued before starting tacrolimus monotherapy.

The patients were instructed to apply the tacrolimus ointment twice daily to the entire affected area and to cover the wound with nonadherent gauze and a foam dressing. The planned duration of treatment was 16 weeks, but one patient with peristomal PG achieved complete clearing within 10 weeks. Another patient benefited with near complete healing, although the other three patients discontinued early for various reasons.

"Complete clearing of peristomal PG with topical tacrolimus has been reported previously in the literature. Given those responses, we have undertaken a case series to further evaluate tacrolimus in the management of these particular lesions," said Dr. Fivenson.