Demographics and baseline disease characteristics
| Mean (SD) or n (%), unless specified | PBO pooled, n=1042 | MTX pooled, n=530 | ADA 40 mg EOW, n=579 | UPA all phase III long term | |
| Any UPA 15 mg once daily, n=2630 | Any UPA 30 mg once daily, n=1204 | ||||
| Short-term data up to 12/14 weeks | Long-term MTX monotherapy Mean exposure: 36 weeks (data censored at rescue) | Long-term ADA Mean exposure: 42 weeks (includes UPA→ADA post-switch) | Long-term UPA (monotherapy or in combination with MTX/other csDMARDs) Mean exposures: 53 weeks (UPA 15 mg) and 59 weeks (UPA 30 mg) | ||
| Female | 822 (78.9%) | 419 (79.1%) | 470 (81.2%) | 2102 (79.9%) | 948 (78.7%) |
| Age, years | 54.8 (12.2) | 54.1 (12.2) | 54.1 (11.7) | 54.1 (12.1) | 55.3 (11.9) |
| Geographic region | |||||
| North America | 321 (30.8%) | 110 (20.8%) | 122 (21.1%) | 689 (26.2%) | 429 (35.6%) |
| South/Central America | 181 (17.4%) | 121 (22.8%) | 126 (21.8%) | 529 (20.1%) | 153 (12.7%) |
| Western Europe | 92 (8.8%) | 45 (8.5%) | 29 (5.0%) | 200 (7.6%) | 129 (10.7%) |
| Eastern Europe | 360 (34.5%) | 164 (30.9%) | 249 (43.0%) | 934 (35.5%) | 351 (29.2%) |
| Asia | 37 (3.6%) | 54 (10.2%) | 18 (3.1%) | 135 (5.1%) | 85 (7.1%) |
| Other | 51 (4.9%) | 36 (6.8%) | 35 (6.0%) | 143 (5.4%) | 57 (4.7%) |
| Time since RA diagnosis, years | 9.0 (8.5) | 3.9 (6.0) | 8.2 (8.0) | 7.7 (8.1) | 7.0 (8.3) |
| Median (range) | 6.4 (0.3 to 49.8) | 1.2 (0.03 to 38.0) | 5.5 (0.3 to 51.1) | 4.8 (0.04 to 54.2) | 3.7 (0.03 to 51.3) |
| DAS28-CRP | 5.8 (0.9) | 5.8 (1.0) | 5.2 (1.3) | 5.3 (1.3) | 5.4 (1.2) |
| CRP, mg/L | 16.5 (20.2) | 18.5 (20.5) | 14.2 (20.5) | 17.0 (21.5) | 15.9 (19.8) |
| Concomitant csDMARD at baseline | |||||
| MTX alone | 914 (87.9%) | NA | 576 (99.5%) | 1769 (67.3%) | 380 (31.6%) |
| MTX plus other csDMARD | 68 (6.5%) | NA | 0 | 103 (3.9%) | 81 (6.7%) |
| csDMARD other than MTX | 58 (5.6%) | NA | 0 | 105 (4.0%) | 100 (8.3%) |
| Prior bDMARD use | 261 (25.0%) | 0 | 57 (9.8%) | 406 (15.4%) | 281 (23.3%) |
| Concomitant steroids | 573 (55.0%) | 279 (52.6%) | 349 (60.3%)* | 1446 (55.0%)† | 570 (47.3%)† |
| Seropositive (RF or ACPA) | 880 (84.5%) | 424 (80.0%) | 497 (85.8%) | 2237 (85.1%) | 948 (78.7%) |
| Prior history of herpes zoster | 58 (5.6%) | 20 (3.8%) | 22 (3.8%) | 110 (4.2%) | 87 (7.2%) |
| Prior history of herpes zoster vaccination | 52 (5.1%) | 17 (3.2%) | 15 (2.6%) | 80 (3.0%) | 72 (6.0%) |
| Positive TB test at screening | 124 (12.0%) | 66 (12.5%) | 77 (13.3%) | 299 (11.4%) | 119 (9.9%) |
| CV risk factors at baseline | |||||
| Medical history of hypertension | 425 (40.8%) | 203 (38.3%) | 248 (42.8%) | 1043 (39.7%) | 481 (40.0%) |
| Diabetes mellitus | 77 (7.4%) | 36 (6.8%) | 41 (7.1%) | 212 (8.1%) | 90 (7.5%) |
| History of tobacco/nicotine use (current+former) | 371 (35.6%) | 207 (39.1%) | 199 (34.4%) | 998 (37.9%) | 509 (42.3%) |
| Elevated LDL-C (≥3.36 mmol/L) | 275 (26.6%) | 163 (30.9%) | 200 (34.5%) | 723 (27.5%) | 318 (26.5%) |
| Lowered HDL-C (≤1.55 mmol/L) | 594 (57.0%) | 301 (56.8%) | 283 (48.9%) | 1504 (57.2%) | 705 (58.6%) |
| Statin use at baseline | 128 (12.3%) | 60 (11.3%) | 58 (10.0%) | 300 (11.4%) | 168 (14.0%) |
All percentages calculated are on non-missing values.
*Baseline is redefined as start of ADA.
†Baseline is redefined as start of UPA.
ACPA, anti-citrullinated protein antibody; ADA, adalimumab; bDMARD, biologic disease-modifying antirheumatic drug; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CV, cardiovascular; DAS28-CRP, Disease Activity Score for 28 joints-CRP; EOW, every other week; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; MTX, methotrexate; NA, not applicable; PBO, placebo; RA, rheumatoid arthritis; RF, rheumatoid factor; TB, tuberculosis; UPA, upadacitinib.