Table 2

Baseline demographics, disease characteristics and cardiovascular risk factors

PBO controlledLong 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 years53±12.653±12.454±12.653±12.853±12.8
 ≥65 years135 (17.4)151 (19.2)158 (20.2)410 (18.1)327 (19.9)
 ≥75 years26 (3.3)27 (3.4)25 (3.2)76 (3.4)67 (4.1)
Female633 (81.5)636 (80.7)638 (81.7)1828 (80.6)1319 (80.1)
Race
 Asian137 (17.6)136 (17.3)124 (15.9)372 (16.4)286 (17.4)
 Black or African American21 (2.7)20 (2.5)35 (4.5)63 (2.8)53 (3.2)
 White543 (69.9)548 (69.5)528 (67.6)1568 (69.2)1137 (69.0)
 Other76 (9.8)83 (10.5)90 (11.5)262 (11.6)170 (10.3)
Hispanic or Latino151 (19.4)169 (21.4)173 (22.2)525 (23.2)355 (21.6)
BMI, mean±SD kg/m2 27.6±6.2527.4±6.2827.7±6.2827.6±6.2027.6±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 years8.6±8.29.1±8.08.6±8.16.3±7.67.4±7.8
Range, years0.3–49.70.1–41.80.1–51.40.0–52.30.0–51.4
hsCRP, mean±SD mg/L18.2±21.419.3±25.918.0±24.418.9±24.518.6±25.6
DAS28 (CRP), mean±SD5.9±0.95.8±1.05.9±0.95.8±0.95.8±1.0
CDAI, mean±SD40.5±12.3839.9±12.5940.4±11.6940.4±12.2639.7±12.23
HAQ-DI, mean±SD1.65±0.6111.61±0.6371.66±0.6001.62±0.6231.62±0.618
Concurrent oral corticosteroids* 300 (38.6)305 (38.7)297 (38.0)781 (34.5)631 (38.3)
 Mean±SD mg/day6.3±2.696.3±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 bDMARDs181 (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
 Current84 (13.5)95 (15.0)88 (14.1)244193
 Former85 (13.7)81 (12.8)80 (12.8)236174
Medical history310 (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)
 Hypertension263 (33.8)276 (35.0)274 (35.1)766 (33.8)560 (34.0)
 Dyslipidaemia118 (15.2)130 (16.5)147 (18.8)336 (14.8)280 (17.0)
 CVD47 (6.0)30 (3.8)44 (5.6)111 (4.9)69 (4.2)
 Ischaemic CNS vascular conditions17 (2.2)17 (2.2)19 (2.4)51 (2.2)34 (2.1)
 Peripheral vascular disease5 (0.2)6 (0.4)
 DVT/PE6 (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.