Modified-Release Prednisone for Rheumatoid Arthritis
Using modified-release prednisone instead of standard prednisone significantly reduces the duration of morning stiffness in patients with rheumatoid arthritis (RA). This is the conclusion of authors of an Article in the January 19 issue of The Lancet.
Circadian (day-night) rhythms of naturally occurring cortisol and anti-inflammatory protection are changed in patients with RA. A new modified-release delivery system has been developed that adapts the release of the administered glucocorticoid (prednisone) to the circadian rhythms of the disease symptoms, and improves the performance of the treatment.
Professor Frank Buttgereit, Charité University Medicine Berlin, Germany, and colleagues did a study of 288 patients with active RA, half of which received a modified-release prednisone tablet, and the other half a standard (immediate-release) prednisone tablet. The modified-release tablet was taken at bedtime and released the prednisone four hours after ingestion; this method was compared to morning administration of immediate-release prednisone. Morning stiffness of the joints was measured in both groups at baseline and again 12 weeks later.
Both groups had a reduced time of morning stiffness, but the group receiving the modified-release tablets had an average time of morning stiffness 29 minutes less than the standard-release group.
The authors say: “It took two years of drug engineering and phase I clinical trials to develop a formulation that could be tested in the phase III clinical trial reported here.” They add that the new formulation has a special coating that bursts four hours after intake because of water penetration; but the total drug exposure and maximum concentration values are almost identical to those of standard prednisone.
They conclude: “Our results have confirmed that the new modified-release formulation is clinically and statistically better than the conventional immediate-release preparation with regard to morning stiffness of the joints. Furthermore, the effects of the new tablet taken at night were achieved in addition to the established clinical control of the disease resulting from previous treatment with conventional immediate-release prednisone.”
This article was adapted from a press release issued by The Lancet.