Results of the clinical trial program in Mexico with deflazacort in rheumatoid arthritis

A prospective, open, non-comparative study was conducted to evaluate the efficacy and safety of deflazacort in 46 patients with rheumatoid arthritis. Twenty-one physicians from all over the country provided patients to the study. Mean age was 47.1 years and 80% were females, with duration of the disease of 10 years as an average. Each patient had a first visit and then four controls at 30, 60, 90 and 120 days. Several clinical parameters were measured for efficacy which improved significantly from second control visit (p < 0.0001). Vital signs were not significantly changed. In general terms the parameters used to evaluate the possibility of Cushing's syndrome decreased without statistical significance. Adverse events were acute gastritis (9%), echinosis (7%) and alterations corresponding to the Cushing's syndrome (7%); there were no treatment suspensions due to adverse reactions events. It is concluded that the clinical efficacy obtained with deflazacort in patients with rheumatoid arthritis is high and statistically significant. Although the decrease observed in regards to Cushing's syndrome data was not significant, there was a trend that probably reflects the need for increasing the duration of treatment. Deflazacort is an efficacious and well tolerated corticosteroid and constitutes an excellent alternative for patients with rheumatoid arthritis that require long term treatment improving quality of life.