Table 2.
Baseline demographics, disease characteristics and cardiovascular risk factors
| PBO controlled | Long term, as-treated | ||||
| FIL 200 mg N=777 |
FIL 100 mg N=788 |
PBO N=781 |
FIL 200 mg N=2267 |
FIL 100 mg N=1647 |
|
| Age, mean±SD years | 53±12.6 | 53±12.4 | 54±12.6 | 53±12.8 | 53±12.8 |
| ≥65 years | 135 (17.4) | 151 (19.2) | 158 (20.2) | 410 (18.1) | 327 (19.9) |
| ≥75 years | 26 (3.3) | 27 (3.4) | 25 (3.2) | 76 (3.4) | 67 (4.1) |
| Female | 633 (81.5) | 636 (80.7) | 638 (81.7) | 1828 (80.6) | 1319 (80.1) |
| Race | |||||
| Asian | 137 (17.6) | 136 (17.3) | 124 (15.9) | 372 (16.4) | 286 (17.4) |
| Black or African American | 21 (2.7) | 20 (2.5) | 35 (4.5) | 63 (2.8) | 53 (3.2) |
| White | 543 (69.9) | 548 (69.5) | 528 (67.6) | 1568 (69.2) | 1137 (69.0) |
| Other | 76 (9.8) | 83 (10.5) | 90 (11.5) | 262 (11.6) | 170 (10.3) |
| Hispanic or Latino | 151 (19.4) | 169 (21.4) | 173 (22.2) | 525 (23.2) | 355 (21.6) |
| BMI, mean±SD kg/m2 | 27.6±6.25 | 27.4±6.28 | 27.7±6.28 | 27.6±6.20 | 27.6±6.20 |
| ≥25 kg/m2 | 472 (60.7) | 496 (62.9) | 482 (61.7) | 1402 (61.8) | 1034 (62.8) |
| ≥30 kg/m2 | 229 (29.5) | 234 (29.7) | 235 (30.1) | 668 (29.5) | 498 (30.2) |
| Duration of RA from diagnosis, mean±SD years | 8.6±8.2 | 9.1±8.0 | 8.6±8.1 | 6.3±7.6 | 7.4±7.8 |
| Range, years | 0.3–49.7 | 0.1–41.8 | 0.1–51.4 | 0.0–52.3 | 0.0–51.4 |
| hsCRP, mean±SD mg/L | 18.2±21.4 | 19.3±25.9 | 18.0±24.4 | 18.9±24.5 | 18.6±25.6 |
| DAS28 (CRP), mean±SD | 5.9±0.9 | 5.8±1.0 | 5.9±0.9 | 5.8±0.9 | 5.8±1.0 |
| CDAI, mean±SD | 40.5±12.38 | 39.9±12.59 | 40.4±11.69 | 40.4±12.26 | 39.7±12.23 |
| HAQ-DI, mean±SD | 1.65±0.611 | 1.61±0.637 | 1.66±0.600 | 1.62±0.623 | 1.62±0.618 |
| Concurrent oral corticosteroids* | 300 (38.6) | 305 (38.7) | 297 (38.0) | 781 (34.5) | 631 (38.3) |
| Mean±SD mg/day | 6.3±2.69 | 6.3±2.57 | |||
| Concurrent csDMARDs* | 710 (91.4) | 721 (91.5) | 712 (91.2) | 1843 (81.3) | 1500 (91.1) |
| Concurrent MTX* | 685 (88.2) | 692 (87.8) | 678 (86.8) | 1219 (53.8) | 1100 (66.8) |
| Prior exposure to bDMARDs | 181 (23.3) | 179 (22.7) | 164 (21.0) | 276 (12.2) | 255 (15.5) |
| Concurrent oral contraceptive* | 51 (6.6) | 53 (6.7) | 31 (4.0) | 127 (5.7)† | 97 (6.1)† |
| Concurrent statin* | 68 (8.8) | 95 (12.1) | 93 (11.9) | 213 (9.4) | 186 (11.3) |
| Nicotine use‡ | |||||
| Current | 84 (13.5) | 95 (15.0) | 88 (14.1) | 244 | 193 |
| Former | 85 (13.7) | 81 (12.8) | 80 (12.8) | 236 | 174 |
| Medical history | 310 (39.9)§ | 349 (44.3)§ | 331 (42.4)§ | 950 (41.9)¶ | 740 (44.9)¶ |
| Diabetes‡ | 76 (12.2) | 61 (9.6) | 69 (11.1) | 221 (9.7) | 158 (9.6) |
| Hypertension | 263 (33.8) | 276 (35.0) | 274 (35.1) | 766 (33.8) | 560 (34.0) |
| Dyslipidaemia | 118 (15.2) | 130 (16.5) | 147 (18.8) | 336 (14.8) | 280 (17.0) |
| CVD | 47 (6.0) | 30 (3.8) | 44 (5.6) | 111 (4.9) | 69 (4.2) |
| Ischaemic CNS vascular conditions | 17 (2.2) | 17 (2.2) | 19 (2.4) | 51 (2.2) | 34 (2.1) |
| Peripheral vascular disease | – | – | – | 5 (0.2) | 6 (0.4) |
| DVT/PE | 6 (0.8) | 7 (0.9) | 11 (1.4) | 18 (0.8)† | 14 (0.9)† |
Data are n (%) unless otherwise indicated. DVT/PE were unadjudicated.
*On first dosing date in parent study.
†For FIL 200 mg and FIL 100 mg, n=2227 and 1600.
‡PBO-controlled group includes patients enrolled in phase 3 trials only. For FIL 200 mg, FIL 100 mg, and PBO, n=622, 633 and 623.
§Excluding diabetes and peripheral vascular disease.
¶Excluding DVT/PE.
bDMARD, biological DMARD; BMI, body mass index; CDAI, Clinical Disease Activity Index; CNS, central nervous system; CRP, C reactive protein; csDMARD, conventional synthetic DMARD; CVD, cardiovascular disease; DAS28(CRP), Disease Activity Score with 28 joints using CRP; DMARD, disease-modifying antirheumatic drug; DVT, deep vein thrombosis; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire Disability Index; hsCRP, high sensitivity CRP; MTX, methotrexate; PBO, placebo; PE, pulmonary embolism; RA, rheumatoid arthritis.