Baseline demographics and measures of disease activity
| Characteristic | Placebo controlled | All-Bari-SLE (N=1655) | ||
| Placebo (N=635) | Bari 2 mg (N=641) | Bari 4 mg (N=634) | ||
| Mean age, years (SD) | 42.8 (12.8) | 42.8 (12.4) | 42.1 (12.5) | 42.8 (12.5) |
| Female, n (%) | 597 (94.0) | 599 (93.4) | 601 (94.8) | 1557 (94.1) |
| Race,* n (%) | ||||
| White | 384 (60.5) | 392 (61.2) | 382 (60.3) | 998 (60.3) |
| Asian | 145 (22.8) | 145 (22.6) | 144 (22.7) | 374 (22.6) |
| Black or African American | 58 (9.1) | 55 (8.6) | 63 (9.9) | 156 (9.4) |
| American Indian or Alaska Native | 35 (5.5) | 33 (5.1) | 30 (4.7) | 87 (5.3) |
| Other | 6 (0.9) | 7 (1.1) | 6 (0.9) | 17 (1.0) |
| Time since diagnosis of SLE, years (SD) | 9.1 (7.8) | 9.3 (7.9) | 9.0 (8.4) | 9.3 (8.1) |
| Age at diagnosis of SLE, years (SD) | 34.2 (12.5) | 33.9 (12.3) | 33.5 (12.2) | 33.9 (12.2) |
| Mean SLEDAI-2K score (SD) | 9.9 (3.2) | 10.0 (3.4) | 9.9 (3.1) | 8.9 (3.9) |
| SLEDAI-2K score ≥10, n (%) | 347 (54.6) | 349 (54.4) | 345 (54.4) | 758 (45.8) |
| Concomitant medications, n (%) | ||||
| Glucocorticoids | 500 (78.7) | 502 (78.3) | 485 (76.5) | 1281 (77.4) |
| Mean prednisone dose (or equivalent), mg/day | 9.2 (5.2) | 9.8 (6.1) | 9.6 (5.7) | 12.4 (7.0) |
| Prednisone dose (or equivalent), ≥10 mg/day | 257 (40.5) | 256 (39.9) | 251 (39.6) | 930 (56.2) |
| Antimalarials | 516 (81.3) | 489 (76.3) | 512 (80.8) | 1316 (79.5) |
| Immunosuppressants | 345 (54.3) | 347 (54.1) | 335 (52.8) | 898 (54.3) |
| Methotrexate | 122 (19.2) | 125 (19.5) | 126 (19.9) | 334 (20.2) |
| Azathioprine | 100 (15.7) | 112 (17.5) | 86 (13.6) | 254 (15.3) |
| Mycophenolate mofetil | 86 (13.5) | 77 (12.0) | 78 (12.3) | 212 (12.8) |
| Non-steroidal anti-inflammatory drug | 141 (22.2) | 163 (25.4) | 170 (26.8) | 430 (26.0) |
| Anti-cardiolipin positive† | 41 (7.7) | 51 (9.5) | 54 (10.2) | 142 (9.8) |
| Anti-beta-2-glycoprotein I positive† | 38 (7.2) | 49 (9.1) | 51 (9.6) | 131 (9.1) |
| Lupus-coagulant positive† | 53 (10.0) | 55 (10.3) | 56 (10.6) | 146 (10.1) |
Data are mean (SD) or n (%). Percentages are based on non-missing data.
*Other includes native Hawaiian or other Pacific Islander and multiple races.
†Assessed in the phase 3 studies and LTE only: n=530, 536, 530 and 1446 for placebo, baricitinib 2 mg, baricitinib 4 mg and All-Bari-SLE, respectively.
Bari, baricitinib; LTE, long-term extension; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index-2000.