Drug Topics (07/27/12)
Prednisone delayed-release tablets have been approved by the Food and Drug Administration for treating a wide spectrum of illnesses such as rheumatoid arthritis (RA), polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease. Supporting the agency's approval was information spanning the pharmacokinetics of prednisone delayed-release tablets to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial showed that individuals with moderate to severe RA treated with prednisone delayed-release tablets experienced a statistically substantial improvement in ACR20 response criteria versus placebo. Also demonstrated by CAPRA-2 outcomes was a statistically significant improvement in ACR50 response compared to placebo and an improvement in ACR70 response criteria.