LONG-TERM THERAPY WITH THE NEW GLUCOCORTICOSTEROID DEFLAZACORT IN RHEUMATOID-ARTHRITIS - DOUBLE-BLIND CONTROLLED RANDOMIZED 12-MONTHS STUDYAGAINST PREDNISONE

The long-term anti-inflammatory and immunosuppressive properties and t he safety of deflazacort (Calcort(R), CAS 14484-47-0) were assessed in vestigating the effect on clinical symptoms and safety parameters in p atients with rheumatoid arthritis compared to prednisone as standard t herapy in a randomized double-blind controlled clinical trial. Monitor ing was performed according to GCP-guidelines closely in order to have a maximun of the patients entered completed at the end of the 12-mont h therapy with high data quality 76 patients, meeting the criteria for classical or definite rheumatoid arthritis and requiring corticostero id therapy, were randomly allocated to a 12-months treatment with eith er deflazacort (6 mg/tablet) or the corticoid standard prednisone (5 m g/tablet). Steady state dosage between 1/2 and 3 tablets per day was i ndividually adjusted according to rite severity of the clinical sympto ms. Due to the close monitoring of the trial in the 6 study centres, 2 5 patients completed 12 months of deflazacort and 28 patients 12 month s of prednisone treatment, being controlled 7 times during the trial. Five efficacy parameters were assessed at each visit. Ritchie Index, d uration 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 labo ratory parameters at 6 visits; ECG at 3 visits; and the global toleran ce was assessed-at the end of the study. Although the majority of the patients were pretreated and substituted equivalently directly, by stu dy medication, improvement of all clinical parameters of efficacy was observed without statistical differences between the two treatment gro ups The average daily dosage for individual sufficient treatment was f or the last 3 treatment months 8.5 mg deflazacort and 7.3 mg prednison e. A therapeutic equipotency within the 90% confidence interval could be proved. The 32 safely laboratory parameters did not reveal any sign ificant changes nor trends between either treatment. Sum score of Cush ing's symptoms was lower under deflazacort treatment (52) compared to prednisone (116). Other adverse events occurred in 13%/16% of the pati ents under deflazacort/prednisone treatment.