Table 2

Mean change from baseline at week 12 in clinical variables and health-related quality-of-life end points*

LSM Change from baseline
MR PrednisonePlaceboLSM Difference±SEp Value
ACR core set measures
Tender joint count−4.7−2.7−2.0±0.60.001
Swollen joint count−3.3−2.2−1.1±0.40.009
Patient pain score−21.0−12.7−8.3±2.50.001
Patient global score−17.3−7.9−9.3±2.5<0.001
Physician global score−22.8−13.1−9.6±2.2<0.001
HAQ-DI score−0.238−0.079−0.16±0.04<0.001
CRP, mg/l0.860.880.98§0.86
ESR after 1 h, mm/h−7.3−5.9−1.4±1.50.34
Other clinical end points
Severity of morning stiffness−27.4−19.6−7.8±2.80.007
Recurrence of stiffness, % of days (mean)−20.3−6.7−13.6±4.50.003
Morning pain score−23.1−16.4−6.7±2.60.012
Evening pain score−20.2−14.9−5.3±2.70.049
DAS28 score−1.15−0.63−0.52±0.13<0.001
Health-related quality of life
FACIT-fatigue score3.81.62.2±0.80.003
SF-36 physical component score3.61.32.3±0.6<0.001
SF-36 mental component score2.00.91.1±0.70.14
  • * Plus-minus values are means±SD.

  • See figure 2 for changes in ACR20 response rate and duration of morning stiffness. Changes in interleukin 6 and tumour necrosis factor α from baseline to week 12 are described in the text.

  • Values in mm, measured using a 0–100 visual analogue scale.

  • § Geometric mean titre ratio for MR prednisone versus placebo.

  • ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Functional Disability Index of the Health Assessment Questionnaire; LSM, least-squares mean; MR, modified release; SF-36, 36-item Short-Form Health Survey.