Table 2.
Change from baseline at week 24 and week 52 for patient-reported outcomes
| PRO measurea (95% CI) | Week 24 | Week 52 | ||||
|---|---|---|---|---|---|---|
| MTX (N = 210) | Baricitinib 4 mg (N = 159) | Baricitinib 4 mg + MTX (N = 215) | MTX (N = 210) | Baricitinib 4 mg (N = 159) | Baricitinib 4 mg + MTX (N = 215) | |
| Physical Function (HAQ-DI) | − 0.74 (− 0.83, − 0.66) | − 1.04 (− 1.14, − 0.95)*** | − 1.03 (− 1.11, − 0.95)*** | − 0.71 (− 0.79, − 0.62) | − 0.99 (− 1.08, − 0.89)*** | − 1.06 (− 1.14, − 0.97)*** |
| Patient’s Global Assessment of Disease Activity (PtGA) | − 31 (− 34, − 27) | − 41 (− 45, − 38)*** | − 40 (− 43, − 37)*** | − 29 (− 32, − 26) | − 40 (− 44, − 37)*** | − 43 (− 46, − 39)*** |
| Patient’s assessment of pain | − 30 (− 33, − 27) | − 41 (− 45 − 37)*** | − 41 (− 44, − 38)*** | − 31 (− 34, − 27) | − 40 (− 44, − 37)*** | − 43 (− 47, − 40)*** |
| FACIT-F | 8.9 (7.6, 10.1) | 13.3 (11.8, 14.7)*** | 12.2 (11.0, 13.5)*** | 8.9 (7.6, 10.2) | 11.7 (10.2, 13.1)** | 12.6 (11.4, 13.9)*** |
| MJS Duration, median change from baseline | − 35.0 (− 55.0, − 25.0) | − 50.0 (− 60.0, − 30.0) | − 59.0 (− 85.0, − 40.0)** | − 40.0 (− 55.0, − 30.0) | − 55.0 (− 60.0, − 40.0) | − 60.0 (− 80.0, − 50.0)** |
| Worst Joint Pain NRS | − 2.8 (− 3.2, − 2.5) | − 4.0 (− 4.3, − 3.6) *** | − 4.0 (− 4.3, − 3.7)*** | − 3.0 (− 3.4, − 2.7) | − 3.9 (− 4.3, − 3.6)*** | − 4.1 (− 4.4, − 3.8)*** |
| Worst Tiredness NRS | − 2.1 (− 2.5, − 1.8) | − 3.1 (− 3.5, − 2.7)*** | − 3.0 (− 3.3, − 2.7)*** | − 2.2 (− 2.5, − 1.8) | − 3.0 (− 3.4, − 2.6)** | − 2.9 (− 3.3, − 2.6)** |
| EuroQol-5 Dimensions (EQ-5D) | ||||||
| Health State Index Score, UK algorithm | 0.200 (0.173, 0.227) | 0.288 (0.257, 0.318)*** | 0.288 (0.261, 0.315)*** | 0.191 (0.161, 0.221) | 0.272 (0.239, 0.306)*** | 0.273 (0.244, 0.303)*** |
| US algorithm | 0.138 (0.119, 0.158) | 0.199 (0.177, 0.221) *** | 0.199 (0.179, 0.218) *** | 0.133 (0.111, 0.154) | 0.187 (0.163, 0.211)*** | 0.189 (0.168, 0.210)*** |
| Self-perceived health score | 15 (12, 18) | 24 (20, 27)*** | 22 (18, 25)** | 14 (11, 18) | 25 (21, 28)*** | 25 (22, 28)*** |
CI confidence interval, MJS morning joint stiffness, MTX methotrexate, NRS numeric rating scale, PRO patient-reported outcomes, RA rheumatoid arthritis
aData are presented as least-squares mean unless stated otherwise
*p ≤ 0.05; **p ≤ 0.01; ***p ≤ 0.001 vs. MTX