Patient-reported outcomes at week 12 and week 24
| Patient-reported outcome measure (least-squares mean (95% CI) from baseline at week 12 or 24, unless specified otherwise) | Week 12 | Week 24 | ||||
|---|---|---|---|---|---|---|
| Placebo (N=176) | Baricitinib 2 mg (N=174) | Baricitinib 4 mg (N=177) | Placebo (N=176) | Baricitinib 2 mg (N=174) | Baricitinib 4 mg (N=177) | |
| EQ-5D-5L | ||||||
| Health State Index Score | ||||||
| UK algorithm | 0.036 (−0.000 to 0.073) | 0.114*** (0.077 to 0.150) | 0.169*** (0.133 to 0.205) | 0.038 (−0.000 to 0.076) | 0.111** (0.073 to 0.149) | 0.159*** (0.122 to 0.197) |
| US algorithm | 0.026 (0.001 to 0.051) | 0.079*** (0.054 to 0.103) | 0.116*** (0.091 to 0.141) | 0.025 (−0.002 to 0.051) | 0.074** (0.048 to 0.100) | 0.107*** (0.081 to 0.133) |
| VAS | 2.9 (−1.1 to 6.9) | 11.3*** (7.3 to 15.4) | 9.0* (5.0 to 12.9) | 1.9 (−2.3 to 6.2) | 7.9* (3.7 to 12.2) | 11.3*** (7.1 to 15.5) |
| Physical function (HAQ-DI) | −0.17 (−0.26 to −0.08) | −0.37*** (−0.46 to −0.28) | −0.41*** (−0.49 to −0.32) | −0.15 (−0.24 to −0.05) | −0.38*** (−0.47 to −0.29) | −0.43*** (−0.52 to −0.34) |
| % with HAQ-DI <0.5 | 6% | 14%* | 14%* | 3% | 16%*** | 16%*** |
| PtGA (VAS) | −8.9 (−13.0 to −4.9) | −20.4*** (−24.4 to −16.3) | −23.0*** (−27.0 to −19.0) | −8.8 (−13.1 to −4.6) | −20.3*** (−24.6 to −16.1) | −24.8*** (−29.0 to −20.6) |
| Patient's assessment of pain (VAS) | −8.8 (−12.9 to −4.7) | −17.1*** (−21.2 to −13.0) | −22.3*** (−26.3 to −18.2) | −8.8 (−13.2 to −4.3) | −18.8*** (−23.2 to −14.4) | −24.0*** (−28.5 to −19.6) |
| FACIT-F | 5.2 (3.5 to 6.9) | 8.3** (6.6 to 9.9) | 8.1** (6.5 to 9.8) | 5.7 (4.0 to 7.5) | 8.1* (6.4 to 9.9) | 9.2** (7.5 to 11.0) |
Lower scores indicate better outcomes for HAQ-DI, PtGA, patient's assessment of pain. Higher scores indicate better outcomes for EQ-5D.
*p≤0.05, **p≤0.01, ***p≤0.001 versus placebo.
EQ-5D-5L, European Quality of Life-5 Dimensions-5 Levels; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; PtGA, Patient's Global Assessment of Disease Activity; VAS, visual analogue scale.