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

Citation
Dp. Jewell et Je. Lennardjones, ORAL CYCLOSPORINE FOR CHRONIC ACTIVE CROHNS-DISEASE - A MULTICENTER CONTROLLED TRIAL, European journal of gastroenterology & hepatology, 6(6), 1994, pp. 499-505
Citations number
NO
Categorie Soggetti
Gastroenterology & Hepatology
ISSN journal
0954691X
Volume
6
Issue
6
Year of publication
1994
Pages
499 - 505
Database
ISI
SICI code
0954-691X(1994)6:6<499:OCFCAC>2.0.ZU;2-O
Abstract
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 placeb o 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 dis ease requiring greater-than-or-equal-to 10 mg prednisolone daily and/o r azathioprine to control symptoms, and patients relapsing within 4 we eks of finishing one of these treatments. No case record form was comp leted for one patient. The data were analysed on an intention-to-treat basis for 146 patients. Outcome measures: Clinical response was defin ed as the resolution of symptoms or a significant improvement on withd rawal or reduction of prednisolone. Disease activity was also assessed by the Harvey-Bradshaw Activity Index and laboratory indicators of ac tivity (erythrocyte sedimentation rate, C-reactive protein). Results: No significant differences were observed between the two groups with r espect to clinical outcome, corticosteroid dosage required, or changes in the indices of activity over the 3-month trial period. Adverse rea ctions in the cyclosporin-treated patients were not uncommon, but none were serious or prolonged. Conclusion: This trial does not support th e value of oral cyclosporin (5 mg/kg) for the management of chronic ac tive Crohn's disease.