Table 1.
Patient characteristics and disease activity at baseline before start of the double-blind trial phase of the total study population (N=288) and of the group of patients continuing treatment with open-label modified-release prednisone (N=249)
| Double-blind population at baseline (N=288)* | Open-label population at baseline (N=249) | |
|---|---|---|
| Age (years) | ||
| Mean (SD) | 55.0 (11.2) | 54.7 (11.1) |
| Range | 20–79 | 20–78 |
| Age class (n (%)) | ||
| ≤45 years | 49 (17.0) | 42 (16.9) |
| >45 and ≤65 years | 185 (64.2) | 163 (65.5) |
| >65 and ≤75 years | 49 (17.0) | 41 (16.5) |
| >75 years | 5 (1.7) | 3 (1.2) |
| Weight (kg) | ||
| Mean (SD) | 70.6 (14.7) | 70.8 (14.8) |
| Range | 43–115 | 43–115 |
| Gender (n (%)) | ||
| Men | 41 (14.2) | 33 (13.3) |
| Women | 247 (85.8) | 216 (86.7) |
| Ethnic origin | ||
| White | 287 (99.7) | 248 (99.6) |
| Asian | 1 (0.3) | 1 (0.4) |
| Disease activity (n (%)) | ||
| Asymptomatic | 0 | 0 |
| Mild | 27 (9.4) | 23 (9.2) |
| Moderate | 205 (71.2) | 175 (70.3) |
| Severe | 56 (19.4) | 51 (20.5) |
| Very severe (physician's assessment) | 0 | 0 |
| Duration of MS (min) | ||
| Mean (SD) | 173.4 (114.2) | 169.8 (114.4) |
| Range | 13–720 | 32–720 |
| Pain intensity VAS (mm) | ||
| Mean (SD) | 58.8 (15.3) | 52.0 (16.14) |
| Range | 16–96 | 6–97 |
| DAS 28 | ||
| Mean (SD) | 5.9 (0.8) | 5.9 (0.8) |
| Range | 3.3–8.1 | 3.3–8.1 |
| HAQ-DI score | ||
| Mean (SD) | 1.5 (0.5) | 1.5 (0.6) |
| Range | 0.0–2.9 | 0.0–2.8 |
| Duration of RA (months) | ||
| Mean (SD) | 115.3 (92.7) | 115.0 (92.5) |
| Median | 90.0 | 91.0 |
| Range | 3–526 | 3–526 |
| Previous RA treatments | ||
| Stable dose prednisone (mg) | ||
| Mean (SD) | 6.6 (2.2)† | 6.6 (2.2) |
| Range | 2.0–10.0 | 2.0–10.0 |
| DMARDs (n (%)) | 272 (94.4) | 238 (95.6)‡ |
In contrast to the previously reported baseline characteristics, data here have not been separated for the two randomised study groups.
Mean prednisone doses for the two treatment groups in the double-blind phase were 6.5 mg for modified-release (MR) prednisone group and 6.7 mg for immediate-release (IR) prednisone group.
Three patients added a DMARD during the open-label extension, increasing this number to 241 (96.8%).
DAS28, Disease Activity Score of 28 joints; DMARDs, disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire Disability Index; MS, morning stiffness of the joints; N, number of subjects enrolled; n, number of available observations; RA, rheumatoid arthritis; VAS, visual analogue scale.