PT - JOURNAL ARTICLE AU - Frank Buttgereit AU - Daksha Mehta AU - John Kirwan AU - Jacek Szechinski AU - Maarten Boers AU - Rieke E Alten AU - Jerzy Supronik AU - Istvan Szombati AU - Ulrike Romer AU - Stephan Witte AU - Kenneth G Saag TI - Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2) AID - 10.1136/annrheumdis-2011-201067 DP - 2013 Feb 01 TA - Annals of the Rheumatic Diseases PG - 204--210 VI - 72 IP - 2 4099 - http://ard.bmj.com/content/72/2/204.short 4100 - http://ard.bmj.com/content/72/2/204.full SO - Ann Rheum Dis2013 Feb 01; 72 AB - Objective To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). Methods In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. Results MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). Conclusion Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. ClinicalTrials.gov, number NCT00650078