Baseline demographics and disease characteristics
| FIL200 (n=475) | FIL100 (n=480) | ADA (n=325) | PBO (n=475) | Total (N=1755) | |
| Sex at birth, n (%), female | 379 (79.8) | 399 (83.1) | 266 (81.8) | 391 (82.3) | 1435 (81.8) |
| Age, years | 52±12.8 | 53±12.6 | 53±12.9 | 53±12.8 | 53±12.7 |
| Weight, kg | 70.6±17.5 | 69.9±16.9 | 71.5±17.4 | 70.6±16.8 | 70.6±17.1 |
| Body mass index, kg/m2 | 26.7±5.7 | 26.4±5.8 | 26.9±6.0 | 27.0±5.9 | 26.7±5.8 |
| Race, n (%) | |||||
| White | 312 (65.7) | 324 (67.5) | 229 (70.5) | 319 (67.2) | 1184 (67.5) |
| Asian | 122 (25.7) | 115 (24.0) | 65 (20.0) | 109 (22.9) | 411 (23.4) |
| American Indian/Alaska Native | 27 (5.7) | 27 (5.6) | 20 (6.2) | 29 (6.1) | 103 (5.9) |
| Black/African American | 6 (1.3) | 7 (1.5) | 10 (3.1) | 12 (2.5) | 35 (2.0) |
| Other* | 8 (1.7) | 6 (1.3) | 1 (0.3) | 5 (1.1) | 20 (1.1) |
| Not permitted | 0 | 1 (0.2) | 0 | 1 (0.2) | 2 (0.1) |
| Ethnicity, n (%) | |||||
| Not Hispanic or Latino | 404 (85.1) | 399 (83.1) | 268 (82.5) | 400 (84.2) | 1471 (83.8) |
| Duration of RA diagnosis, years | 7.3±7.4 | 8.5±8.2 | 8.0±7.4 | 7.3±7.2 | 7.8±7.6 |
| hsCRP, mg/L | 16.1±21.0 | 16.7±23.0 | 14.6±18.0 | 16.3±24.1 | 16.0±21.9 |
| Median (Q1, Q3) | 8.8 (3.6, 21.2) | 9.0 (3.9, 20.7) | 8.0 (3.4, 17.2) | 7.5 (3.3, 19.8) | 8.2 (3.6, 19.9) |
| ≥6 mg/L, n (%) | 298 (62.7) | 295 (61.5) | 197 (60.6) | 274 (57.7) | 1064 (60.6) |
| RF-positive, n (%) | 352 (74.1) | 362 (75.4) | 241 (74.2) | 365 (76.8)† | 1320 (75.2)† |
| Anti-CCP-positive, n (%) | 380 (80.0) | 381 (79.4) | 253 (77.8)‡ | 378 (79.6) | 1392 (79.3)‡ |
| RF and anti-CCP positive, n (%) | 331 (69.7) | 332 (69.2) | 219 (67.4)‡ | 333 (70.1)† | 1215 (69.2)†‡ |
| mTSS units§ | 32.5±47.9 | 36.7±53.1 | 34.8±55.0 | 31.6±53.2 | 33.8±52.1 |
| Median (Q1, Q3) | 12.0 (2.0, 43.5) | 13.0 (2.5, 52.5) | 12.5 (2.0, 43.5) | 11.5 (2.0, 37.0) | 12.0 (2.0, 43.5) |
| Erosion score >0, n (%)¶ | 399 (84.0) | 411 (85.6) | 277 (85.2) | 404 (85.1) | 1491 (85.0) |
| JSN score | 18.5±25.6 | 19.9±27.3 | 19.6±28.2 | 17.6±26.9 | 18.8±26.9 |
| bDMARD-naïve, n (%) | 458 (96.4) | 464 (96.7) | 317 (97.5) | 469 (98.7) | 1708 (97.3) |
| MTX dose, mg/week** | 15.3±4.9 | 15.5±4.8 | 15.4±4.8 | 14.9±4.5 | 15.3±4.8 |
| Concurrent oral steroids, n (%) | 229 (48.2) | 229 (47.7) | 140 (43.1) | 217 (45.7) | 815 (46.4) |
| ≤5 mg/day, n (%)†† | 152 (66.4) | 160 (69.9) | 96 (68.6) | 152 (70.0) | 560 (68.7) |
| Steroid dose, mg/day‡‡ | 6.2±3.4 | 6.1±2.5 | 5.9±2.2 | 5.9±2.5 | 6.0±2.8 |
| Concurrent antimalarials, n (%) | 64 (13.5) | 59 (12.3) | 39 (12.0) | 63 (13.3) | 225 (12.8) |
| DAS28(CRP) | 5.8±0.9 | 5.7±1.0 | 5.7±0.9 | 5.7±0.9 | 5.7±0.9 |
| SDAI | 41.2±12.3 | 40.2±12.8 | 40.6±11.9 | 41.2±12.4 | 40.8±12.4 |
| CDAI | 39.5±11.9 | 38.6±12.2 | 39.2±11.5 | 39.6±11.7 | 39.2±11.8 |
| SJC66 | 15±8.5 | 15±8.5 | 16±8.4 | 16±8.5 | 16±8.5 |
| TJC68 | 25±13.5 | 25±13.4 | 24±13.2 | 24±13.5 | 24±13.4 |
| SGA, VAS, mm | 67±19.2 | 65±19.7 | 67±19.1 | 68±18.7 | 67±19.2 |
| PGA, VAS, mm | 66±16.0 | 65±16.5 | 67±15.5 | 66±16.2 | 66±16.1 |
| Pain, VAS, mm | 65±20.4 | 64±20.1 | 64±19.5 | 66±19.0 | 65±19.8 |
| HAQ-DI | 1.6±0.6 | 1.6±0.6 | 1.6±0.6 | 1.6±0.6 | 1.6±0.6 |
| SF-36 PCS§§ | 33.4±7.2 | 33.6±7.8 | 32.8±7.7 | 32.9±7.1 | 33.2±7.4 |
| SF-36 MCS¶¶ | 43.9±10.4 | 44.6±10.4 | 44.1±10.4 | 43.4±11.0 | 44.0±10.6 |
| FACIT-F¶¶ | 27.6±10.7 | 27.8±10.6 | 27.2±10.2 | 26.9±10.3 | 27.4±10.5 |
Values are mean±SD.
*Includes patients recorded as Native Hawaiian/Pacific Islander and ‘Other’. Race was not recorded for one patient receiving FIL100 and one patient receiving PBO due to local regulations.
†n=1 missing.
‡n=2 missing.
§Campaign A: FIL200, n=467; FIL100, n=471; ADA, n=319; PBO, n=466.
¶Campaign A: FIL200, n=8 missing; FIL100, n=9 missing; ADA, n=6 missing; PBO, n=9 missing.
**FIL100, n=479; ADA, n=324.
††Percent of patients with concurrent oral corticosteroid use on first dosing date.
‡‡FIL200, n=226; FIL100, n=229; ADA, n=140; PBO, n=217.
§§FIL200, n=473; FIL100, n=479; ADA, n=323; PBO, n=474.
¶¶FIL200, n=472; FIL100, n=477; ADA, n=319; PBO, n=469.
ADA, adalimumab; anti-CCP, anticyclic citrullinated protein antibody; bDMARD, biologic disease-modifying antirheumatic drug; CDAI, Clinical Disease Activity Index; DAS28(CRP), Disease Activity Score in 28 joints with C reactive protein; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high-sensitivity C reactive protein; JSN, joint space narrowing; MCS, Mental Component Summary; mTSS, van der Heijde modified total Sharp score; MTX, methotrexate; PBO, placebo; PCS, Physical Component Summary; PGA, Physician’s Global Assessment; Q1, first quartile; Q3, third quartile; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; SF-36, Short Form-36; SGA, Subject’s Global Assessment; SJC66, swollen joint count of 66 joints; TJC68, tender joint count of 68 joints; VAS, visual analogue scale.