Measure, mean (SD) | Placebo | Apremilast 20 mg BID | Apremilast 40 mg QD |
---|---|---|---|
Global VAS (0–100) | |||
Baseline | 58.3 (23.87) | 54.3 (19.53) | 55.7 (22.47) |
Week 12/final visit | 59.4 (24.0) | 45.3 (25.9) | 45.0 (25.5) |
Change from baseline | 1.0 (19.2) | −10.3 (24.6)* | −10.4 (23.6)* |
Pain VAS (0–100) | |||
Baseline | 59.7 (22.64) | 55.7 (18.82) | 57.1 (23.77) |
Week 12/final visit | 58.5 (24.4) | 44.9 (25.9) | 44.8 (26.1) |
Change from baseline | −1.3 (19.7) | −11.2 (22.8)* | −11.5 (22.6)* |
HAQ-DI (0–3) | |||
Baseline | 1.24 (0.77) | 0.96 (0.65) | 1.08 (0.71) |
Week 12/final visit | 1.18 (0.78) | 0.80 (0.63) | 0.93 (0.71) |
Change from baseline | −0.05 (0.39) | −0.16 (0.35) | −0.15 (0.39) |
FACIT-F (0–52) | |||
Baseline | 28.8 (11.76) | 32.1 (11.92) | 27.7 (12.78) |
Week 12/final visit | 29.5 (13.33) | 36.2 (11.80) | 32.0 (12.25) |
Change from baseline | 0.5 (8.03) | 4.1 (8.78)* | 4.3 (9.46)* |
SF-36 MCS | |||
Baseline | 43.6 | 45.0 | 43.5 |
Week 12/final visit | 44.0 | 48.3 | 44.7 |
Change from baseline | −0.8 | 3.4* | 1.1 |
SF-36 PCS | |||
Baseline | 33.3 | 37.3 | 34.8 |
Week 12/final visit | 34.1 | 40.2 | 36.9 |
Change from baseline | 0.8 | 2.4* | 2.1 |
↵* p < 0.05 vs. placebo. FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; MCS: mental component summary; PCS: physical component summary; VAS: visual analog scale; SF-36: 36-item Medical Outcomes Study Short-Form Health Survey.