Oral tacrolimus (FK 506) in Crohn's disease complicated by fistulae of theperineum

We describe the cases of two patients with Crohn's disease affected by seve re perineal fistulae resistant to conventional therapies, successfully trea ted with FK 506, a new immunomodulatory drug. It is well absorbed from dise ased bowel and preliminary experiences have indicated its short-ten use in complicated Crohn's disease. The first patient was a 24-year-old male with perineal fistula and severe skin ulceration (8 cm of external opening diame ter). He had undergone colectomy and ileostomy because of severe pancolitis refractory to medical treatment and had been treated with azathioprine and metronidazole. Two months after starting FK 506, a dramatic improvement ma de further surgical operation unnecessary. Local and general benefit was ob served during the following 26 months, until FK 506 was withdrawn. The seco nd patient was a 28-year-old male with a diagnosis of ulcerative pancolitis changed to Crohn's disease two months after the onset of a perineal fistul a, recurring despite drainage procedures, steroid therapy, and total parent eral nutrition. FK 506 was administered for two months with a complete heal ing of fistula. Successively, it was stopped and corticosteroids (associate d to enteral nutrition) were given because of recurrent rectal bleeding. Ou r experience encourages the use of oral FK 506 in complicated Crohn's disea se and suggests the possibility of a long-term primary therapy other thin t he use as a "bridge" to other treatments.