Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)
Annals of Rheumatic Diseases, 05/10/2012
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.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.
- 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%).