EFFICACY AND EFFICIENCY OF ORAL MICROEMULSION CYCLOSPORINE VERSUS INTRAVENOUS AND SOFT GELATIN CAPSULE CYCLOSPORINE IN THE TREATMENT OF SEVERE STEROID-REFRACTORY ULCERATIVE-COLITIS - AN OPEN-LABEL RETROSPECTIVE TRIAL

We have used cyclosporin to treat patients with acute steroid-resistan t ulcerative colitis since the beginning of 1991. Of the 55 patients s o far elected for treatment, 40 received the drug intravenously at 2 m g/kg/day for 14 days, with the responders being maintained on traditio nal soft-gelatin-capsule cyclosporin at a dose of 6-8 mg/kg/day for 6 months; the remaining 15 received oral microemulsion cyclosporin, 5 mg /kg/day, for 3 months. The doses were titrated to ensure whole-blood d rug concentrations of 60-240 ng/ml, with levels of -200 ng/ml being at tained by both regimens. One-hundred percent of the patients receiving oral microemulsion cyclosporin and 65% of those receiving the intrave nous regimen achieved a short-term response (p = 0.011). Both the resp onder subsets received additional azathioprine and relapsed on treatme nt with the same frequency of 40%. However, 17% of the patients who re ceived intravenous cyclosporin developed major toxicity (including one fatality), whereas no major toxicity was observed in the oral microem ulsion cyclosporin group. The microemulsion formulation was therefore more effective than intravenous cyclosporin in achieving the shortterm remission of steroid-unresponsive ulcerative colitis. As the maintena nce drug, it led to the same frequency of disease relapse as tradition al oral cyclosporin. However, because it did not involve invasive in-h ospital procedures or cause major toxicity, it was more efficient than the combination of the intravenous and traditional oral drug.