Patient characteristics, disease activity and patient-reported outcomes at baseline
| Placebo (N=228) | Baricitinib 2 mg (N=229) | Baricitinib 4 mg (N=227) | |
|---|---|---|---|
| Patient characteristics | |||
| Age, years | 51.4 (13) | 52.2 (12) | 51.8 (12) |
| Female patients, n (%) | 189 (83) | 184 (80) | 187 (82) |
| Duration of RA (time from symptom onset), years | 7.2 (8) | 7.6 (8) | 7.7 (8) |
| Concomitant corticosteroid use, n (%) | 114 (50) | 117 (51) | 115 (51) |
| Concomitant MTX use, n (%) | 167 (73) | 170 (74) | 171 (75) |
| Mean (SD) MTX dose, mg/week | 16 (5) | 16 (5) | 16 (5) |
| Number of prior csDMARDS, n (%) | |||
| 1 | 96 (42) | 104 (45) | 98 (43) |
| 2 | 81 (36) | 61 (27) | 68 (30) |
| ≥3 | 50 (22) | 61 (27) | 60 (26) |
| Number of concomitant csDMARDs, n (%) | |||
| 0 | 17 (8) | 18 (8) | 13 (6) |
| 1 | 150 (66) | 145 (63) | 151 (67) |
| MTX | 109 (48) | 111 (49) | 114 (50) |
| Non-MTX | 41 (18) | 34 (15) | 37 (16) |
| 2 | 55 (24) | 58 (25) | 57 (25) |
| MTX + non-MTX | 52 (23) | 51 (22) | 51 (23) |
| 2 non-MTX | 3 (1) | 7 (3) | 6 (3) |
| ≥3 | 6 (3) | 8 (4) | 6 (3) |
| Disease activity | |||
| Swollen joint count, of 66 | 13 (7) | 14 (9) | 14 (7) |
| Tender joint count, of 68 | 24 (15) | 24 (14) | 24 (14) |
| hsCRP, mg/L | 18 (20) | 18 (22) | 14 (15) |
| ESR, mm/hour | 44 (25) | 44 (23) | 41 (24) |
| DAS28-hsCRP | 5.5 (0.9) | 5.6 (1.0) | 5.6 (0.9) |
| SDAI | 37 (12) | 38 (13) | 38 (12) |
| CDAI | 35 (12) | 37 (13) | 36 (12) |
| Patient-reported outcome measures | |||
| Health Assessment Questionnaire-Disability Index (HAQ-DI, 0–3) | 1.50 (0.60) | 1.51 (0.62) | 1.55 (0.60) |
| Patient's Global Assessment of Disease Activity (0–100 VAS) | 60 (21) | 62 (20) | 60 (22) |
| Patient's Assessment of Pain (0–100 VAS) | 57 (23) | 60 (21) | 57 (22) |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F, 0–52) | 26.6 (11.1) | 26.6 (11.5) | 27.3 (11.1) |
| Short Form 36 (SF-36) | |||
| Physical component score (PCS) | 32.2 (8.5) | 32.5 (8.4) | 32.2 (8.1) |
| Mental component score (MCS) | 45.7 (11.5) | 45.0 (11.5) | 46.3 (12.3) |
| European Quality of Life-5 Dimensions-5 Level (EQ-5D) | |||
| Health State Index Score, UK algorithm | 0.543 (0.214) | 0.507 (0.249) | 0.516 (0.236) |
| VAS (0–100) | 51.6 (19.7) | 53.1 (20.5) | 52.8 (20.0) |
Data displayed are mean (SD), unless otherwise stated.
CDAI, Clinical Disease Activity Index; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DAS, Disease Activity Score modified to include the 28 diarthrodial joint count; ESR, erythrocyte sedimentation rate; hsCRP, high-sensitivity C reactive protein; MTX, methotrexate; SDAI, Simplified Disease Activity Index; VAS, visual analogue scale.