Baseline demographics and clinical characteristics
| FIL 200 mg+MTX n=416 | FIL 100 mg+MTX n=207 | FIL 200 mg n=210 | MTX n=416 | Total N=1249 | |
| Age, years | 53 (13.8) | 54 (12.6) | 52 (13.9) | 53 (13.7) | 53 (13.6) |
| ≥65 years, n (%) | 87 (21) | 39 (19) | 40 (19) | 87 (21) | 253 (20) |
| ≥70 years, n (%) | 42 (10) | 18 (9) | 22 (11) | 44 (11) | 126 (10) |
| ≥75 years, n (%) | 21 (5) | 7 (3) | 10 (5) | 16 (4) | 54 (4) |
| Female, n (%) | 325 (78%) | 158 (76%) | 166 (79%) | 312 (75%) | 961 (77%) |
| Race, n (%) | |||||
| White | 278 (67%) | 132 (64%) | 135 (64%) | 278 (67%) | 823 (66%) |
| Asian | 90 (22%) | 51 (25%) | 47 (22%) | 85 (20%) | 273 (22%) |
| American Indian or Alaska Native | 26 (6%) | 12 (6%) | 18 (9%) | 33 (8%) | 89 (7%) |
| Black or African American | 15 (4%) | 8 (4%) | 8 (4%) | 14 (3%) | 45 (4%) |
| Native Hawaiian or Pacific Islander | 1 (<1%) | 0 | 1 (1%) | 3 (1%) | 5 (<1%) |
| Other* | 6 (1%) | 4 (2%) | 0 | 3 (1%) | 13 (1%) |
| Not permitted* | 0 | 0 | 1 (1%) | 0 | 1 (<1%) |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 93 (22%) | 40 (19%) | 45 (21%) | 84 (20%) | 262 (21%) |
| Not Hispanic or Latino | 322 (77%) | 167 (81%) | 165 (79%) | 332 (80%) | 986 (79%) |
| Not permitted* | 1 (<1%) | 0 | 0 | 0 | 1 (<1%) |
| Geographical region,† n (%) | |||||
| Region A | 173 (42%) | 85 (41%) | 86 (41%) | 170 (41%) | 514 (41%) |
| Region B | 149 (36%) | 75 (36%) | 76 (36%) | 149 (36%) | 449 (36%) |
| Region C | 58 (14%) | 28 (14%) | 28 (13%) | 56 (14%) | 170 (14%) |
| Region D | 13 (3%) | 8 (4%) | 8 (4%) | 16 (4%) | 45 (4%) |
| Region E | 23 (6%) | 11 (5%) | 12 (6%) | 25 (6%) | 71 (6%) |
| BMI, median (Q1, Q3), kg/m2 | 26.8 (23.0, 31.2) | 26.7 (23.5, 31.3) | 26.4 (23.3, 30.0) | 26.8 (23.1, 31.5) | 26.7 (23.1, 31.1) |
| Smoking status, n (%) | |||||
| Non-smoker | 300 (72%) | 146 (71%) | 151 (72%) | 287 (69%) | 884 (71%) |
| Former smoker | 64 (15%) | 32 (16%) | 24 (11%) | 70 (17%) | 190 (15%) |
| Current smoker | 52 (13%) | 29 (14%) | 35 (17%) | 59 (14%) | 175 (14%) |
| RA duration, years | 1.9 (3.6) | 2.3 (4.7) | 2.6 (6.3) | 2.3 (5.5) | 2.2 (5.0) |
| Median | 0.4 | 0.4 | 0.4 | 0.3 | 0.4 |
| ≤6 month | 229 (55%) | 111 (54%) | 116 (55%) | 230 (55%) | 686 (55%) |
| 6 month–1 year | 40 (10%) | 27 (13%) | 21 (10%) | 52 (13%) | 140 (11%) |
| ≥1 year | 147 (35%) | 69 (33%) | 73 (35%) | 134 (32%) | 423 (34%) |
| RF or anti-CCP positive, n (%) | 317 (76%) | 162 (78%) | 158 (75%) | 322 (77%) | 959 (77%) |
| hsCRP (mg/L) | 18.0 (25.3) | 17.7 (27.4) | 17.3 (23.2) | 16.9 (24.4) | 17.5 (25.0) |
| mTSS erosions>0, n (%) | 392 (94%) | 197 (95%) | 199 (95%) | 385 (93%) | 1173 (94%) |
| DMARD naïve, n (%) | 319 (77%) | 159 (77%) | 164 (78%) | 322 (77%) | 964 (77%) |
| Prior non-MTX csDMARD use, n (%) | 73 (18%) | 38 (18%) | 35 (17%) | 76 (18%) | 222 (18%) |
| Concurrent antimalarial use, n (%) | 35 (8%) | 24 (12%) | 17 (8%) | 42 (10%) | 118 (9%) |
| Concurrent oral steroid use, n (%) | 143 (34%) | 88 (43%) | 89 (42%) | 174 (42%) | 494 (40%) |
| Steroid dose, mg/day | 6.6 (2.3) | 7.2 (2.9) | 6.6 (2.2) | 6.5 (2.3) | 6.6 (2.4) |
| DAS28(CRP) | 5.7 (1.0) | 5.7 (1.0) | 5.8 (0.9) | 5.7 (1.0) | 5.7 (1.0) |
| SJC66 | 16 (9.8) | 16 (9.3) | 16 (9.7) | 16 (9.4) | 16 (9.6) |
| TJC68 | 26 (14.5) | 25 (13.9) | 26 (13.7) | 26 (13.8) | 26 (14.0) |
| Patient global assessment (VAS) | 65 (21.0) | 66 (21.6) | 68 (19.2) | 66 (21.0) | 66 (20.8) |
| Physician global assessment (VAS) | 66 (17.0) | 68 (6.3) | 66 (14.4) | 67 (16.8) | 67 (16.4) |
| Patient pain (VAS) | 64 (22.0) | 67 (22.1) | 67 (18.4) | 66 (21.4) | 65 (21.3) |
| HAQ-DI | 1.5 (0.6)‡ | 1.6 (0.7) | 1.6 (0.7) | 1.6 (0.6) | 1.6 (0.6) |
| mTSS units§ | 11.4 (20.0) | 13.3 (27.0) | 16.5 (32.4) | 13.7 (29.2) | 13.3 (26.7) |
| CDAI | 39.5 (12.8) | 39.2 (12.7) | 40.0 (12.6) | 40.2 (12.5) | 39.8 (12.6) |
| SDAI | 41.3 (13.4) | 41.0 (13.5) | 41.8 (13.1) | 41.9 (13.4) | 41.5 (13.4) |
| SF-36 PCS | 33.9 (7.5)‡ | 33.7 (8.0) | 33.6 (7.7)¶ | 33.3 (7.3) | 33.6 (7.5) |
| FACIT-F | 28.3 (10.9)** | 27.3 (11.9) | 27.3 (10.9)†† | 27.1 (10.7)‡‡ | 27.6 (11.0) |
Data are mean (SD), unless otherwise indicated.
*Other races included people whose predominant origins cannot be determined or who are of mixed race and do not identify with a primary race. Not permitted category includes patients whose local regulators did not allow collection of race or ethnicity information.
†Region A: USA, Spain, Germany, South Korea, Canada, Belgium, South Africa, Australia, New Zealand, UK, Italy, Ireland, Israel; Region B: India, Poland, Ukraine, Bulgaria, Russia, Czech Republic, Hungary, Serbia, Romania, Slovakia; Region C: Mexico, Argentina, Chile; Region D: Taiwan, Thailand, Malaysia, Hong Kong; Region E: Japan.
‡n=414.
§Campaign A, n=1226.
¶n=208.
**n=411.
††n=206.
‡‡n=415.
BMI, body mass index; CCP, cyclic citrullinated peptides; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic DMARD; DAS28(CRP), 28-joint Disease Activity Score with C-reactive protein; DMARD, disease-modifying antirheumatic drug; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire–Disability Index; hsCRP, high-sensitivity C-reactive protein; mTSS, Modified total Sharp/van der Heijde score; MTX, methotrexate; SF-36 PCS, Short Form 36 Physical Component Summary score; Q1, first quartile; Q3, third quartile; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, simplified disease activity index; SJC66, swollen joint count based on 66 joints; TJC68, tender joint count based on 68 joints; VAS, Visual Analogue Scale.