Table 1

Demographics and baseline clinical characteristics of patients with all four poor prognostic factors and the overall study population

Patients with four poor prognostic factorsOverall
FIL 200 mg + MTX
n=172
FIL 100 mg + MTX
n=85
FIL 200 mg
n=87
MTX
n=166
Total
n=510
Total
N=1249
Age, years51±12.953±12.950±12.853±12.952±12.953±13.6
Female, n (%)133 (77.3)65 (76.5)67 (77.0)128 (77.1)393 (77.1)961 (76.9)
RA duration, years1.8±3.402.8±5.502.4±6.272.7±6.162.4±5.292.2±4.97
 Median (min, max)0.4 (0, 26.8)0.6 (0.1, 31.7)0.3 (0, 47.2)0.6 (0, 52.3)0.5 (0, 52.3)0.4 (0, 52.3)
 ≤6 months, n (%)89 (51.7)41 (48.2)50 (57.5)78 (47.0)258 (50.6)686 (54.9)
 6 months–1 year, n (%)22 (12.8)13 (15.3)7 (8.0)24 (14.5)66 (12.9)140 (11.2)
 ≥1 year, n (%)61 (35.5)31 (36.5)30 (34.5)64 (38.6)186 (36.5)423 (33.9)
Prior non-MTX csDMARD use, n (%)25 (14.5)17 (20.0)15 (17.2)35 (21.1)92 (18.0)222 (17.8)
Prior exposure to MTX, n (%)12 (7.0)7 (8.2)9 (10.3)10 (6.0)38 (7.5)82 (6.6)
Concurrent oral glucocorticoid use, n (%)61 (35.5)45 (52.9)45 (51.7)78 (47.0)229 (44.9)494 (39.6)
 Glucocorticoid dose, mg/day6.9±2.447.2±2.596.5±2.096.3±2.316.7±2.376.6±2.43
Concurrent antimalarial use, n (%)12 (7.0)12 (14.1)6 (6.9)19 (11.4)49 (9.6)118 (9.4)
Seropositivity
 RF, n (%)162 (94.2)75 (88.2)77 (88.5)148 (89.2)462 (90.6)848 (67.9)
 Anti-CCP, n (%)162 (94.2)76 (89.4)76 (87.4)157 (94.6)471 (92.4)855 (68.5)
 RF and anti-CCP, n (%)152 (88.4)66 (77.6)66 (75.9)139 (83.7)423 (82.9)744 (59.6)
 hsCRP, mg/L31.6±31.328.0±28.523.3±24.626.3±27.127.9±28.517.5±25.0
 mTSS erosions >0, n (%)172 (100)85 (100)87 (100)166 (100)510 (100)1173 (93.9)
 SJC6620±11.419±10.819±10.818±10.119±10.816.0±9.6
 TJC6830±14.329±13.128±13.628±14.329±14.026.0±14.0
 Pain (VAS)73±17.073±19.072±16.473±17.073±17.265±21.3
 HAQ-DI1.73±0.591.79±0.631.72±0.691.81±0.551.76±0.601.56±0.634
 DAS28(CRP)6.4±0.736.3±0.726.2±0.676.3±0.726.3±0.725.7±0.99
 CDAI44.8±12.045.1±11.142.7±11.944.2±11.144.3±11.539.8±12.6
 SDAI47.9±12.347.9±11.845.0±11.746.8±11.847.1±11.941.5±13.4
 mTSS units*13.2±23.118.1±35.924.2±44.319.3±37.217.9±34.513.3±26.7
  • Data are shown as mean±SD unless otherwise noted.

  • *Campaign A.

  • CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28(CRP), disease activity score in 28 joints with C reactive protein; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high-sensitivity C reactive protein; mTSS, van der Heijde modified total Sharp score; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatic factor; SD, standard deviation; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.