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 Prednisone	Placebo	LSM Difference±SE	p Value^‡
ACR core set measures
Tender joint count	−4.7	−2.7	−2.0±0.6	0.001
Swollen joint count	−3.3	−2.2	−1.1±0.4	0.009
Patient pain score^‡	−21.0	−12.7	−8.3±2.5	0.001
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/l	0.86	0.88	0.98^§	0.86
ESR after 1 h, mm/h	−7.3	−5.9	−1.4±1.5	0.34
Other clinical end points
Severity of morning stiffness^‡	−27.4	−19.6	−7.8±2.8	0.007
Recurrence of stiffness, % of days (mean)	−20.3	−6.7	−13.6±4.5	0.003
Morning pain score^‡	−23.1	−16.4	−6.7±2.6	0.012
Evening pain score^‡	−20.2	−14.9	−5.3±2.7	0.049
DAS28 score	−1.15	−0.63	−0.52±0.13	<0.001
Health-related quality of life
FACIT-fatigue score	3.8	1.6	2.2±0.8	0.003
SF-36 physical component score	3.6	1.3	2.3±0.6	<0.001
SF-36 mental component score	2.0	0.9	1.1±0.7	0.14

↵* 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.