Cyclosporine A

Ten uncontrolled studies, some published only in abstract form and comprising altogether only 64 patients, examined the effect of intravenous CyA for the treatment of fistulizing CD with an overall initial response of 83% [35-44].

Present and Lichtiger [38] treated 16 patients with Crohn's fistulae (10 perirectal, 4 enterocutaneous, 2 rectovaginal) with cyclosporine A, starting with a continuous intravenous infusion (4 mg/kg/day), switched to the oral route (6-8 mg/kg/day). Fourteen responded to parenteral CyA (7 complete closure, 7 moderate improvement) and discontinued the steroids, with a mean time for response of 7.4 days. When switched to the oral route, 64% remained in remission, 36% relapsed.

These results have been supplemented by a review of literature including 39 patients with fistulizing Crohn's disease who have been treated with CyA [43]. Within this group, 90% responded to intravenous cyclosporine, but 82% relapsed with CyA suspension.

A modest reduction in fistula recurrence has been produced with combined use of CyA, AZA and a tapering schedule of prednisolone over 3 months before cessation of CyA therapy [45]. All nine patients responded to intravenous cyclosporine with no recurrences after its discontinuation. CyA was terminated after 3 months, while AZA and low-dose prednisolone were continued: four patients did not deteriorate, three deteriorated slightly and two had a recurrence.

Adverse events of high dose CyA include paresthe-sias, hypertrichosis, hypertension, tremor, renal insufficiency, hepatotoxicity, headache, opportunistic infections, gingival hyperplasia and seizures [46].

On the base of these studies, it is reasonable to use CyA in fistulizing Crohn's disease in the acute phase; as it will not achieve long-term response, all patients should be treated with concurrent AZA/6-mercap-topurine for maintenance or, if the patient is allergic/intolerant to AZA/6-MP, with parenteral MTX.

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