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| |  Delayed-Release Prednisone May Better Relieve Morning Stiffness in Patients With RA: Presented at ACR/ARHP By Liz Meszaros PHILADELPHIA -- October 19, 2009 -- Chronotherapy with a new modified-release form of low-dose prednisone is more efficacious than conventional immediate-release prednisone in patients with rheumatoid arthritis (RA), according to data presented here October 18 at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). The anti-inflammatory and immunosuppressive effects of glucocorticoids make them an effective treatment for rheumatic diseases. Study author Stephan Witte, MD, and his colleagues from Germany hypothesised that improved timing of glucocorticoid administration according to the circadian rhythms of endogenous cortisol and the common morning symptoms experienced by patients with RA may improve the risk-benefit ratio of these drugs. A previous study (Lancet 2008;371:205-214) showed that the modified-release prednisone tablet was superior to the immediate-release formulation in patients with RA who had been pre-treated with glucocorticoids and disease-modifying anti-rheumatic drugs (DMARDs). “Levels of pro-inflammatory cytokines, such as IL-6, peak during the night. It is established that these nocturnal increases in pro-inflammatory cytokines are the cause of the joint stiffness that very typically appears during the morning hours in patients with RA,” said Dr. Witte, who is with Nitec Pharma GmbH, Manheim, Germany. This new modified-release tablet formulation releases prednisone 4 hours after ingestion. If taken at bedtime, drug release occurs during the night, and this in turn results in peak plasma levels in the early morning, he explained. For this study, Dr. Witte and colleagues randomised 288 patients with a mean disease duration of approximately 10 years to receive modified-release or immediate-release prednisone. During the 3-month, double-blind phase (completed by 251 patients), mean relative reduction of the duration of morning stiffness typical in patients with RA was significantly higher in patients treated with the modified-release prednisone, than in those given immediate-release prednisone (P = .045). Nearly all of the patients who completed the double-blind study continued on modified-release prednisone, with a treatment period of either 12 months (n = 104) or 9 months (n = 115). In the 12-month group, mean relative reduction of morning stiffness was 55%, and in the 9-month group, 45%. Both groups also experienced a one-count reduction in Disease Activity Score (DAS)-28, as well as reductions in intensity of pain as measured on the 100-mm-Visual Analog Scale: 13 mm after 9 months and 11 mm after 12 months. Median reductions in IL-6 of approximately 50% were seen in both groups. By the end of the study periods, 37% of all patients achieved improvement in the signs and symptoms of RA, according to ACR20 criteria. “By optimising the timing of prednisone dosing, you can get all of these benefits,” concluded Dr. Witte. Frank Buttgereit of Charite University Med-Berlin, Berlin, Germany, was the lead author of the study. Support for this study was provided by Merck KGaA and Nitec Pharma GmbH. [Presentation title: Prednisone Chronotherapy of Rheumatoid Arthritis: Sustained Efficacy of a Novel Modified-Release Formulation Over 12 Months. Abstract 409]
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