ORAL CYCLOSPORINE FOR CHRONIC ACTIVE CROHNS-DISEASE - A MULTICENTER CONTROLLED TRIAL

Objective: To determine the role of oral cyclosporin in the management of patients with chronic active Crohn's disease. Design: Double-blind, placebo-controlled study of oral cyclosporin (5 mg/kg) versus placebo in combination with prednisolone over an initial period of 3 months. Patients: The trial included 147 patients with chronic active Crohn's disease. Criteria for entry were as follows: patients with active disease requiring greater-than-or-equal-to 10 mg prednisolone daily and/or azathioprine to control symptoms, and patients relapsing within 4 weeks of finishing one of these treatments. No case record form was completed for one patient. The data were analysed on an intention-to-treat basis for 146 patients. Outcome measures: Clinical response was defined as the resolution of symptoms or a significant improvement on withdrawal or reduction of prednisolone. Disease activity was also assessed by the Harvey-Bradshaw Activity Index and laboratory indicators of activity (erythrocyte sedimentation rate, C-reactive protein). Results: No significant differences were observed between the two groups with respect to clinical outcome, corticosteroid dosage required, or changes in the indices of activity over the 3-month trial period. Adverse reactions in the cyclosporin-treated patients were not uncommon, but none were serious or prolonged. Conclusion: This trial does not support the value of oral cyclosporin (5 mg/kg) for the management of chronic active Crohn's disease.