Long-term therapy with the new glucocorticosteroid deflazacort in rheumatoid arthritis. Double-blind controlled randomized 12-months study against prednisone.

The long-term anti-inflammatory and immunosuppressive properties and the safety of deflazacort (Calcort, CAS 14484-47-0) were assessed investigating the effect on clinical symptoms and safety parameters in patients with rheumatoid arthritis compared to prednisone as standard therapy in a randomized double-blind controlled clinical trial. Monitoring was performed according to GCP-guidelines closely in order to have a maximum of the patients entered completed at the end of the 12-month therapy with high data quality. 76 patients, meeting the criteria for classical or definite rheumatoid arthritis and requiring corticosteroid therapy, were randomly allocated to a 12-months treatment with either deflazacort (6 mg/tablet) or the corticoid standard prednisone (5 mg/tablet). Steady state dosage between 1/2 and 3 tablets per day was individually adjusted according to the severity of the clinical symptoms. Due to the close monitoring of the trial in the 6 study centres, 25 patients completed 12 months of deflazacort and 28 patients 12 months of prednisone treatment, being controlled 7 times during the trial. Five efficacy parameters were assessed at each visit: Ritchie Index, duration of morning stiffness, grip strength, effective dosage of study medication and global assessment of disease status. Following safety and tolerance parameters were controlled during the trial: vital signs, weight, Cushing's symptoms and adverse events at each visit; 32 laboratory parameters at 6 visits; ECG at 3 visits; and the global tolerance was assessed at the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)