Demographics and baseline disease characteristics
| Characteristics | MR prednisone (n=231) | Placebo (n=119) |
|---|---|---|
| Demographic and disease characteristics | ||
| Age, years | ||
| Mean±SD | 57.1±9.9 | 57.5±9.6 |
| Median (range) | 57.0 (27–80) | 58.0 (32–76) |
| Female sex, n (%) | 192 (83.1) | 102 (85.7) |
| White race, n (%) | 226 (97.8) | 118 (99.2) |
| BMI, mean±SD, kg/m2 | 28.0±5.8 | 28.1±5.5 |
| Duration of RA | ||
| Mean (years) | 7.98 | 7.94 |
| <2 Years, n (%) | 41 (17.7) | 29 (24.4) |
| Previous RA treatments, n (%) | ||
| DMARDs | 228 (98.7)* | 119 (100) |
| NSAIDs | 166 (71.9) | 88 (73.9) |
| Other analgesics | 84 (36.4) | 53 (44.5) |
| Biological treatments | 1 (0.4) | 1 (0.8) |
| ACR core set measures, mean±SD (unless stated) | ||
| Tender joint count | 12.6±6.17 | 12.5±5.94 |
| Swollen joint count | 8.4±4.40 | 8.6±4.65 |
| Patient assessment of pain†‡ | 58 (3–96) | 51 (0–95) |
| Patient assessment of disease activity† | 57.4±20.1 | 50.9±20.9 |
| Physician assessment of disease activity† | 55.2±16.1 | 54.1±17.4 |
| HAQ-DI score | 1.3±0.6 | 1.3±0.6 |
| CRP, mg/l‡ | 5.2 (<0.05–91.5) | 5.3 (0.1–136.5) |
| ESR, mm/h‡ | 32 (4–104) | 30 (2–115) |
| Other clinical end points, mean±SD | ||
| Duration of morning stiffness, min | 152.0±92.4 | 156.7±87.7 |
| Severity of morning stiffness† | 54.6±21.7 | 50.7±21.3 |
| Recurrence of stiffness, % of days | 68.3±39.0 | 72.1±37.3 |
| Morning pain score† | 54.9±21.6 | 50.5±22.4 |
| Evening pain score† | 49.9±23.5 | 47.8±21.9 |
| DAS28 | 5.2±0.8 | 5.1±0.8 |
| Health-related quality of life, mean±SD | ||
| FACIT-F score | 28.8±10.4 | 28.7±10.7 |
| SF-36 physical components summary score | 31.6±7.0§ | 31.5±6.9 |
| SF-36 mental components summary score | 45.3±10.7§ | 45.4±9.6 |
| Inflammatory markers, median (range) | ||
| IL-6, pg/ml | <5 (<5–3215)¶ | <5 (<5–266) |
| TNFα, pg/ml | <5 (<5–65)¶ | <5 (<5–15) |
↵* Three patients in the MR prednisone group did not take DMARDs during the study, but they were not uncovered until unblinding.
↵† Values in mm, measured using a 0–100 visual analogue scale.
↵‡ Data presented as median (range).
↵§ Data missing for two patients.
↵¶ Data missing for one patient.
BMI, body mass index; CRP, C-reactive protein; DAS28, 28-joint Disease Activity Score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Functional Disability Index of the Health Assessment Questionnaire; IL-6, interleukin 6; MR, modified release; NSAID, non-steroidal anti-inflammatory drug; RA, rheumatoid arthritis; SF-36, 36-item Short-Form Health Survey; TNF, tumour necrosis factor.