Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)
Annals of Rheumatic Diseases, 05/09/2012
Buttgereit F et al. – Low–dose modified–release (MR) prednisone added to existing disease–modifying antirheumatic drug (DMARD) treatment produced rapid and relevant improvements in rheumatoid arthritis (RA) signs and symptoms.
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.
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%).
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