Secondary efficacy results (full analysis population)
| Parameter | Visit | Modified-release prednisone (N=32) | Immediate-release prednisone (N=30) | Estimate (95% confidence limit)* | p Value for treatment difference | ||
|---|---|---|---|---|---|---|---|
| n | Mean (SD)† | n | Mean (SD)† | ||||
| PMR VAS (0–100 scale) | Baseline | 32 | 80.7 (12.88) | 30 | 81.0 (11.70) | ||
| Week 1 | 31 | −37.1 (25.70) | 30 | −28.2 (27.55) | −9.3 (−22.97 to 4.30) | 0.176 | |
| Week 4 | 27 | −70.4 (20.81) | 23 | −59.8 (24.02) | −12.8 (−22.58 to −3.05) | 0.011 | |
| PMR VAS at awakening (0–100 scale) | Baseline | 32 | 81.7 (17.26) | 30 | 85.9 (9.68) | ||
| Week 1 | 32 | −36.6 (29.40) | 30 | −29.4 (29.78) | −10.9 (−25.45 to 3.61) | 0.138 | |
| Week 4 | 27 | −70.7 (18.72) | 23 | −63.7 (23.25) | −11.6 (−21.33 to −1.79) | 0.021 | |
| Duration of morning stiffness (minutes) | Baseline | 32 | 530 (531.0) | 30 | 616 (591.0) | ||
| Week 1 | 31 | −326 (435.3) | 30 | −160 (412.4) | 134.5 (18.50 to 250.50)‡ | 0.021 | |
| Week 4 | 27 | −457 (517.9) | 23 | −417 (574.7) | 46.9 (−110.00 to 203.83)‡ | 0.592 | |
| Global pain VAS (0–100 scale) | Baseline | 32 | 80.0 (13.14) | 30 | 78.2 (13.96) | ||
| Week 1 | 31 | −36.2 (26.73) | 30 | −27.1 (27.96) | −7.5 (−21.10 to 6.11) | 0.275 | |
| Week 4 | 27 | −68.7 (21.73) | 23 | −55.5 (25.55) | −13.6 (−23.23 to −3.26) | 0.011 | |
| Global pain VAS at awakening (0–100 scale) | Baseline | 32 | 80.6 (18.94) | 30 | 83.4 (13.13) | ||
| Week 1 | 32 | −35.2 (30.03) | 30 | −28.5 (32.46) | −9.1 (−23.78 to 5.57) | 0.219 | |
| Week 4 | 27 | −69.3 (20.67) | 23 | −60.9 (28.28) | −12.3 (−23.23 to −1.42) | 0.028 | |
| Shoulder pain VAS (0–100 scale) | Baseline | 32 | 81.0 (13.31) | 30 | 79.9 (13.01) | ||
| Week 1 | 31 | −36.9 (26.85) | 30 | −28.4 (28.67) | −7.4 (−21.55 to 6.66) | 0.295 | |
| Week 4 | 27 | −68.4 (21.46) | 23 | −57.7 (25.92) | −11.1 (−21.30 to −0.91) | 0.033 | |
| Fatigue VAS (0–100 scale) | Baseline | 32 | 72.9 (19.31) | 30 | 75.7 (14.31) | ||
| Week 1 | 31 | −29.8 (24.94) | 30 | −24.6 (27.66) | −7.8 (−20.67 to 5.07) | 0.230 | |
| Week 4 | 27 | −59.4 (27.34) | 23 | −57.6 (23.16) | −6.4 (−16.76 to 4.05) | 0.225 | |
| C reactive protein (mg/L) | Baseline | 32 | 50.6 (32.34) | 30 | 69.6 (49.38) | ||
| Week 1 | 30 | −40.8 (27.46) | 30 | −48.9 (44.27) | −6.2 (−13.61 to 1.22) | 0.100 | |
| Week 4 | 27 | −44.0 (32.24) | 23 | −52.9 (48.33) | −8.0 (−16.37 to 0.37) | 0.060 | |
| Erythrocyte sedimentation rate (mm/hour) | Baseline | 32 | 66.5 (21.62) | 30 | 68.3 (22.84) | ||
| Week 1 | 29 | −25.8 (17.03) | 35 | −23.9 (15.29) | |||
| Week 4 | 31 | −38.8 (24.14) | 25 | −40.1 (23.65) | Not estimable§ | ||
| Interleukin-6 (pg/mL) | Screening | 28 | 41.4 (34.97) | 30 | 40.9 (35.18) | ||
| Week 4 | 19 | −37.4 (41.27) | 22 | −29.8 (32.61) | −6.5 (−11.84 to −1.23) | 0.017 | |
Larger decreases from baseline represent a favourable treatment effect for all secondary efficacy end points.
*Estimates are least square means with confidence limits from a repeated measures analysis of covariance model, if not stated otherwise.
†Raw mean at screening/baseline and mean change from baseline at weeks 1 and 4.
‡Estimates and confidence limits stem from the Hodges-Lehmann method.
§Convergence criteria not met.
PMR, polymyalgia rheumatica; VAS, visual analogue scale.