Baseline demographics and measures of disease activity.
| Baseline Characteristics | Placebo-4 mg (6 studies, to Week 24) | Placebo-2 mg-4 mg (4 studies, to Week 24), 2 mg-4 mg-extended (4 studies) | All-bari-RA | |||
|---|---|---|---|---|---|---|
| Placebo, n = 1070 | Baricitinib 4 mg, n = 997 | Placebo, n = 551 | Baricitinib 2 mg, n = 479 | Baricitinib 4 mg, n = 479 | All-bari-RA, n = 3492a | |
| Age, yrs, mean (SD) | 52.9 (11.9) | 53.7 (12.0) | 52.4 (12.1) | 53.2 (12.0) | 53.6 (11.7) | 52.9 (12.2) |
| Female, n (%) | 862 (80.6) | 794 (79.6) | 458 (83.1) | 386 (80.6) | 391 (81.6) | 2760 (79.0) |
| Duration of RAb, yrs, mean (SD) | 8.9 (8.4) | 8.9 (8.6) | 8.9 (8.8) | 9.0 (8.1) | 9.1 (8.6) | 7.7 (8.2) |
| Region, n (%) | ||||||
| US/Canada | 240 (22.4) | 225 (22.6) | 177 (32.1) | 162 (33.8) | 162 (33.8) | 840 (24.1) |
| Central/South America, Mexico | 203 (19.0) | 197 (19.8) | 62 (11.3) | 54 (11.3) | 54 (11.3) | 701 (20.1) |
| Asia (minus Japan) | 84 (7.9) | 83 (8.3) | 36 (6.5) | 38 (7.9) | 35 (7.3) | 226 (6.5) |
| Japan | 156 (14.6) | 132 (13.2) | 63 (11.4) | 36 (7.5) | 39 (8.1) | 514 (14.7) |
| European Union | 263 (24.6) | 246 (24.7) | 140 (25.4) | 125 (26.1) | 124 (25.9) | 783 (22.4) |
| Rest of the world | 124 (11.6) | 114 (11.4) | 73 (13.2) | 64 (13.4) | 65 (13.6) | 428 (12.3) |
| Corticosteroid use, n (%) | ||||||
| None | 460 (43.0) | 459 (46.0) | 244 (44.3) | 233 (48.6) | 229 (47.8) | 1738 (49.8) |
| 0.1–4.9 mg/day | 122 (11.4) | 95 (9.5) | 66 (12.0) | 40 (8.4) | 39 ( 8.1) | 326 (9.3) |
| 5–7.4 mg/day | 274 (25.6) | 254 (25.5) | 135 (24.5) | 121 (25.3) | 112 (23.4) | 831 (23.8) |
| 7.5+ mg/day | 214 (20.0) | 189 (19.0) | 106 (19.2) | 85 (17.7) | 99 (20.7) | 597 (17.1) |
| Concomitant MTX use, n (%) | 967 (90.4) | 903 (90.6) | 456 (82.8) | 386 (80.6) | 394 (82.3) | 2661 (76.2) |
| Baseline disease activity, mean (SD) | Placebo, n = 1070 | Baricitinib 4 mg, n = 997 | Placebo, n = 551 | Baricitinib 2 mg, n = 479 | Baricitinib 4 mg, n = 479 | All-bari-RA, n = 3439c |
| SJC of 66 | 15.0 (9.2) | 14.8 (8.0) | 14.6 (8.9) | 15.7 (10.4) | 14.5 (7.7) | 12.0 (9.6) |
| TJC of 68 | 23.8 (14.3) | 24.0 (13.8) | 24.3 (15.0) | 25.6 (15.3) | 24.7 (14.6) | 19.6 (15.2) |
| CDAI | 37.2 (12.7) | 37.7 (12.4) | 36.6 (12.6) | 38.4 (13.3) | 37.3 (12.6) | 30.8 (16.7) |
| DAS28-CRP | 5.63 (0.95) | 5.69 (0.94) | 5.57 (0.96) | 5.69 (0.96) | 5.61 (0.95) | 5.05 (1.47) |
↵a All-bari-RA (patients who received any baricitinib dose) includes patients who switched from placebo, adalimumab, or MTX to baricitinib. Thus, it is a larger group than the 2-mg and 4-mg groups added together.
↵b Time from RA diagnosis.
↵c The number for the all-bari-RA group is smaller for disease activity measures than for demographics because baseline disease activity measures are only available for phase II/III studies. RA: rheumatoid arthritis; MTX: methotrexate; CDAI: Clinical Disease Activity Index; DAS28-CRP: 28-joint count Disease Activity Score using high-sensitivity C-reactive protein; SJC: swollen joint count; TJC: tender joint count.