Table 1

Baseline demographics and disease characteristics

FIL200
(n=475)
FIL100
(n=480)
ADA
(n=325)
PBO
(n=475)
Total
(N=1755)
Sex at birth, n (%), female379 (79.8)399 (83.1)266 (81.8)391 (82.3)1435 (81.8)
Age, years52±12.853±12.653±12.953±12.853±12.7
Weight, kg70.6±17.569.9±16.971.5±17.470.6±16.870.6±17.1
Body mass index, kg/m226.7±5.726.4±5.826.9±6.027.0±5.926.7±5.8
Race, n (%)
 White312 (65.7)324 (67.5)229 (70.5)319 (67.2)1184 (67.5)
 Asian122 (25.7)115 (24.0)65 (20.0)109 (22.9)411 (23.4)
 American Indian/Alaska Native27 (5.7)27 (5.6)20 (6.2)29 (6.1)103 (5.9)
 Black/African American6 (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 permitted01 (0.2)01 (0.2)2 (0.1)
Ethnicity, n (%)
 Not Hispanic or Latino404 (85.1)399 (83.1)268 (82.5)400 (84.2)1471 (83.8)
 Duration of RA diagnosis, years7.3±7.48.5±8.28.0±7.47.3±7.27.8±7.6
hsCRP, mg/L16.1±21.016.7±23.014.6±18.016.3±24.116.0±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±47.936.7±53.134.8±55.031.6±53.233.8±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 score18.5±25.619.9±27.319.6±28.217.6±26.918.8±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±4.915.5±4.815.4±4.814.9±4.515.3±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±3.46.1±2.55.9±2.25.9±2.56.0±2.8
Concurrent antimalarials, n (%)64 (13.5)59 (12.3)39 (12.0)63 (13.3)225 (12.8)
DAS28(CRP)5.8±0.95.7±1.05.7±0.95.7±0.95.7±0.9
SDAI41.2±12.340.2±12.840.6±11.941.2±12.440.8±12.4
CDAI39.5±11.938.6±12.239.2±11.539.6±11.739.2±11.8
SJC6615±8.515±8.516±8.416±8.516±8.5
TJC6825±13.525±13.424±13.224±13.524±13.4
SGA, VAS, mm67±19.265±19.767±19.168±18.767±19.2
PGA, VAS, mm66±16.065±16.567±15.566±16.266±16.1
Pain, VAS, mm65±20.464±20.164±19.566±19.065±19.8
HAQ-DI1.6±0.61.6±0.61.6±0.61.6±0.61.6±0.6
SF-36 PCS§§33.4±7.233.6±7.832.8±7.732.9±7.133.2±7.4
SF-36 MCS¶¶43.9±10.444.6±10.444.1±10.443.4±11.044.0±10.6
FACIT-F¶¶27.6±10.727.8±10.627.2±10.226.9±10.327.4±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.