EUROPEAN TRIAL OF CYCLOSPORINE IN CHRONIC ACTIVE CROHNS-DISEASE - A 12-MONTH STUDY

Background & Aims: The role of cyclosporine in Crohn's disease is controversial. This study aimed to delineate the long-term effect of cyclosporine in chronic active Crohn's disease. Methods: One hundred eighty-two patients from 33 European centers were included. The patient cohort was stratified at entry into a stratum with low Crohn's Disease Activity Index (CDAI) (<200) and high CDAI (>200). The low-activity group continued to receive the pretrial steroid dose for 2 months, and the high-activity group received 1 mg . kg(-1). day(-1) prednisone initially. During months 3 and 4, the dose of steroids was reduced stepwise to 5 mg/day in all patients. Placebo and cyclosporine (5 mg . kg(-1). day(-1)) were administered throughout the 12-month study period. The main parameter of efficacy was the CDAI, and the main end point was the number of patients in remission at month 12. Results: During cyclosporine therapy, 35% (95% confidence interval [95% CI], 25%-46%) of the patients achieved a full remission (CDAI, <150) after 4 months compared with 27% (95% CI, 18%-38%) in the placebo group (P > 0.05). At month 12, only 20% (95% CI, 12%-31%) vs. 20% (95% CI, 12%-31%) of the patients had maintained a continuous remission. No major differences between treatment groups were found within each of the two strata. Conclusions: The long-term treatment of chronic active Crohn's disease with cyclosporine plus low-dose steroids does not offer an advantage compared with low-dose steroids atone.