Table 1 Patient characteristics, disease activity, and patient-reported outcomes at baseline*
Parametera | MTX (N = 210) | Baricitinib 4 mg (N = 159) | Baricitinib 4 mg + MTX (N = 215) |
|---|---|---|---|
Age, years | 50.5 (13) | 50.9 (13) | 48.5 (14) |
Female, n (%) | 148 (70) | 121 (76) | 156 (73) |
Duration of RA, years | 1.3 (4.0) | 1.9 (4.7) | 1.3 (2.7) |
Duration of RA, years, median | 0.2 | 0.2 | 0.2 |
Concomitant corticosteroid use, n (%) | 76 (36) | 47 (30) | 83 (39) |
Number of previous cDMARDs used, n (%) | |||
 0 | 190 (90) | 146 (92) | 197 (92) |
 1 | 20 (10) | 13 (8) | 18 (8) |
 2 | 0 | 0 | 0 |
Ever used DMARD (≤ 3 doses of MTX permitted), n (%) | 20 (10) | 13 (8) | 18 (8) |
Disease activity | |||
 Swollen joint count, of 66 | 16 (11) | 16 (9) | 16 (10) |
 Tender joint count, of 68 | 27 (15) | 26 (14) | 28 (15) |
 DAS28-hsCRP | 5.9 (1.0) | 5.9 (1.0) | 5.9 (0.9) |
 DAS28-ESR | 6.6 (1.0) | 6.6 (1.1) | 6.6 (1.0) |
 Simplified Disease Activity Index | 42 (14) | 43 (14) | 43 (13) |
 Clinical Disease Activity Index | 39 (13) | 40 (13) | 40 (13) |
Patient-reported outcomes | |||
 HAQ-DI (0–3) | 1.7 (0.7) | 1.6 (0.7) | 1.6 (0.7) |
 PtGA VAS (0–100) | 66 (24) | 65 (22) | 63 (24) |
 Patient’s assessment of pain, VAS (0–100) | 65 (24) | 64 (22) | 63 (23) |
 Fatigue (FACIT-F; 0–52) | 27 (11) | 28 (11) | 28 (11) |
 Median (IQR) duration of morning joint stiffness, minutes | 90 (30, 180) | 60 (30, 180) | 90 (30, 180) |
 Worst Joint Pain NRS (0–10) | 7 (2) | 7 (2) | 7 (2) |
 Worst Tiredness NRS (0–10) | 6 (2) | 6 (3) | 6 (2) |
QoL (SF-36; 0–100) | |||
 PCS | 32 (8) | 33 (8) | 32 (9) |
 MCS | 47 (12) | 45 (13) | 47 (13) |
EQ-5D | |||
 Health State Index Score, UK algorithm (-0.594,1) | 0.473 (0.256) | 0.485 (0.255) | 0.489 (0.251) |
 Self-perceived health score VAS (0–100) | 51 (23) | 50 (23) | 51 (23) |