Table 1. Baseline characteristics at LTE baseline.
| FIL200 | FIL100 | Total (n=2729) | |||||
| With continued FIL (n=1195) | With de novo FIL (n=335) | Total (n=1530) | With continued FIL (n=863) | With de novo FIL (n=336) | Total (n=1199) | ||
| Age (years), mean (SD) | 53 (13.2) | 54 (12.1) | 53 (12.9) | 54 (12.4) | 55 (13.9) | 54 (12.8) | 54 (12.9) |
| Duration of RA from diagnosis (years)* | |||||||
| Mean (SD) | 6.7 (7.43) | 6.9 (8.59) | 6.7 (7.70) | 8.5 (8.02) | 6.8 (7.61) | 8.0 (7.94) | 7.3 (7.83) |
| Median (IQR) | 3.8 (1.6–8.7) | 3.5 (1.5–9.0) | 3.8 (1.5–8.8) | 5.7 (2.2–12.0) | 4.0 (1.4–9.8) | 5.1 (1.9–11.4) | 4.3 (1.7–9.9) |
| Female, n (%) | 960 (80.3) | 267 (79.7) | 1227 (80.2) | 699 (81.0) | 272 (81.0) | 971 (81.0) | 2198 (80.5) |
| Baseline BMI (kg/m2), mean (SD) | 27.9 (6.29) | 27.9 (6.42) | 27.9 (6.32) | 27.9 (6.40) | 27.9 (6.14) | 27.9 (6.32) | 27.9 (6.32) |
| Current smoker, n (%) | 160 (13.4) | 48 (14.3) | 208 (13.6) | 119 (13.8) | 39 (11.6) | 158 (13.2) | 366 (13.4) |
| Parent study, n (%) | |||||||
| FINCH 1 | 571 (47.8) | 128 (38.2) | 699 (45.7) | 570 (66.0) | 130 (38.7) | 700 (58.4) | 1399 (51.3) |
| FINCH 2 | 132 (11.0) | 59 (17.6) | 191 (12.5) | 124 (14.4) | 55 (16.4) | 179 (14.9) | 370 (16.6) |
| FINCH 3 | 492 (41.2) | 148 (44.2) | 640 (41.8) | 169 (19.6) | 151 (44.9) | 320 (26.7) | 960 (35.2) |
| hsCRP (mg/L),mean (SD) | n=119440.90 (8.77) | n=33570.53 (11.56) | n=152950.48 (9.51) | n=85960.55 (11.20) | n=33370.50 (12.45) | n=119260.82 (11.57) | n=272160.07 (10.48) |
| DAS28-CRP, mean (SD) | n=119120.5 (1.08) | n=33430.0 (1.27) | n=152520.6 (1.14) | n=85520.8 (1.15) | n=33320.9 (1.24) | n=118820.8 (1.18) | n=271320.7 (1.16) |
| DAS28-CRP ≤3.2, n (%) | 919 (77.2) | 208 (62.3) | 1127 (73.9) | 592 (69.2) | 210 (63.1) | 802 (67.5) | 1929 (71.1) |
| HAQ-DI, mean (SD) | n=119200.66 (0.62) | n=33400.81 (0.65) | n=152600.69 (0.63) | n=86100.78 (0.67) | n=33600.84 (0.69) | n=119700.80 (0.68) | n=272300.74 (0.65) |
| SDAI, mean (SD) | n=119070.6 (8.10) | n=334110.0 (10.82) | n=152480.4 (8.87) | n=85390.2 (8.96) | n=333100.3 (10.19) | n=118690.5 (9.33) | n=271080.9 (9.09) |
| CDAI, mean (SD) | n=119170.2 (7.90) | n=334100.2 (10.38) | n=152570.8 (8.59) | n=85780.5 (8.61) | n=33690.6 (9.66) | n=119380.8 (8.93) | n=271880.3 (8.75) |
| Patient’s pain assessment (mm),mean (SD) | n=119123 (23.0) | n=33429 (26.1) | n=152624 (23.8) | n=86126 (23.8) | n=33630 (26.8) | n=119727 (24.7) | n=272325 (24.3) |
| Prior exposure to bDMARDs, n (%) | 146 (12.2) | 186 (55.5) | 332 (21.7) | 134 (15.5) | 185 (55.1) | 319 (26.6) | 651 (23.9) |
| To adalimumab in FINCH 1 | – | 128 (38.2) | 128 (8.4) | – | 130 (38.7) | 130 (10.8) | 258 (9.5) |
| Concurrent oral CS on first dosing date,n (%) | 471 (39.4) | 146 (43.6) | 617 (40.3) | 395 (48.8) | 130 (38.7) | 525 (43.8) | 1142 (41.8) |
| Concurrent methotrexate on first dosing date, n (%) | 624 (52.2) | 158 (47.2) | 782 (51.1) | 598 (69.3) | 156 (46.4) | 754 (62.9) | 1536 (56.3) |
| Number of concurrent csDMARDs on first dosing date, n (%) | |||||||
| 0 | 504 (42.2) | 154 (46.0) | 658 (43.0) | 230 (26.7) | 154 (45.8) | 384 (32.0) | 1042 (38.2) |
| 1 | 627 (52.5) | 164 (49.0) | 791 (51.7) | 563 (65.2) | 166 (49.4) | 729 (60.8) | 1520 (55.7) |
| ≥2 | 64 (5.4) | 17 (5.1) | 81 (5.3) | 70 (8.1) | 16 (4.8) | 86 (7.2) | 167 (6.1) |
| Race, n (%) | |||||||
| American Indian or Alaska Native | 82 (6.9) | 25 (7.5) | 107 (7.0) | 58 (6.7) | 27 (8.0) | 85 (7.1) | 192 (7.0) |
| Asian | 251 (21.0) | 60 (17.9) | 311 (20.3) | 186 (21.6) | 60 (17.9) | 246 (20.5) | 557 (20.4) |
| Black or African American | 32 (2.7) | 13 (3.9) | 45 (2.9) | 21 (2.4) | 20 (6.0) | 41 (3.4) | 86 (3.2) |
| Native Hawaiian or Pacific Islander | 1 (<0.1) | 0 | 1 (<0.1) | 0 | 0 | 0 | 1 (<0.1) |
| White | 817 (68.4) | 233 (69.6) | 1050 (68.6) | 585 (67.8) | 226 (67.3) | 811 (67.6) | 1861 (68.2) |
| Other | 11 (0.9) | 3 (0.9) | 14 (0.9) | 12 (1.4) | 3 (0.9) | 15 (1.3) | 29 (1.1) |
| Not reported | 1 (<0.1) | 1 (0.3) | 2 (0.1) | 1 (0.1) | 0 | 1 (<0.1) | 3 (0.1) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 221 (18.5) | 69 (20.6) | 290 (19.0) | 150 (17.4) | 72 (21.4) | 222 (18.5) | 512 (18.8) |
| Not Hispanic or Latino | 968 (81.0) | 265 (79.1) | 1233 (80.6) | 704 (81.6) | 264 (78.6) | 968 (80.7) | 2201 (80.7) |
| Not reported | 6 (0.5) | 1 (0.3) | 7 (0.5) | 9 (1.0) | 0 | 9 (0.8) | 16 (0.6) |
Concurrent medication use was defined as medications taken while a patient was receiving the study drug; patients started concurrent medication prior to the first dosing. Concurrent oral corticosteroids use on as -needed frequency was excluded from the mean oral corticosteroids daily dose.
*
Duration of RA (years) = (first dose date in LTE – date of initial diagnosis+1)/365.25.
bDMARDbiologic disease-modifying anti-rheumatic drugBMIbody mass indexCDAIClinical Disease Activity IndexCScorticosteroidcsDMARDconventional synthetic disease-modifying anti-rheumatic drugDAS28-CRPDisease Activity Score 28 using C-reactive proteinFIL(100/200)filgotinib (100 mg/200 mg)HAQ-DIHealth Assessment Questionnaire–Disability IndexhsCRPhigh-sensitivity C-reactive proteinLTElong-term extensionRArheumatoid arthritisSDAISimplified Disease Activity Index