Oral microemulsion cyclosporin to reduce steroids rapidly in chronic active ulcerative colitis.

ABSTRACT

OBJECTIVE: The list of the therapeutic tools for chronic active ulcerative colitis lacks a potent and reliably absorbed immune modifier to help wean patients from steroids. We investigated whether oral microemulsion cyclosporin (Neoral) can achieve this goal. DESIGN: Retrospective analysis. SETTING: Tertiary care referral centre. PARTICIPANTS: Nine consecutive patients facing colectomy because of steroid-dependent chronic active ulcerative colitis were studied the disease was left-sided in six of them and had lasted a median of 10 years. Two patients depended on prednisone 12.5 mg/day, six on 25 mg, and one on 35 mg. The median cumulative steroid dose in the month preceding the trial had been 750 mg. INTERVENTIONS: Neoral was started at a dose of 5 mg/kg/day, which was then titrated to reach a whole-blood therapeutic range of 60-240 ng/ml. During the three-month trial, previous drugs were continued but steroids were tapered according to the patient's clinical condition. PRIMARY OUTCOME MEASURES: The number of patients leaving the trial with quiescent disease and a significantly decreased need for steroids. RESULTS: Eight of the nine patients (89%) showed an initial response and commenced tapering steroids. Remission to the end of the 3rd month was observed in five cases treated with < or = 15 mg steroids daily (median cumulative dose 150 mg). Of the remaining four cases, two were partial responders and two failures, with the failure being linked to poor drug absorption in at least one patient. CONCLUSION: Neoral may help wean patients with chronic active ulcerative colitis from steroids, but this novel indication of cyclosporin must be tested in a specifically designed study.