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) |
Score ranges for individual patient-reported outcomes measures are indicated in brackets. Lower scores indicate better outcomes for HAQ-DI, PtGA, patient’s assessment of pain, Worst Joint Pain, Worst Tiredness. Higher scores indicate better outcomes for FACIT-F, SF-36 and EQ-5D
EQ-5D European Quality of Life-5 Dimensions, FACIT-F Functional Assessment of Chronic Illness Therapy–Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, IQR interquartile range, MCS Mental Component Score, MTX methotrexate, NRS numeric rating scale, PCS Physical Component Score, PtGA Patient’s Global Assessment of Disease Activity, QoL quality of life, RA rheumatoid arthritis, SF-36 Short Form-36, UK United Kingdom, VAS visual analog scale
aData are presented as mean (standard deviation) unless stated otherwise
*Further details can be found in Fleischmann et al. 2017 [1]