Demographics and baseline characteristics (all data represent characteristics at entry into the parent studies).
| Filgotinib + MTX, n = 497 | Filgotinib Monotherap n = 242 | Total, n = 739 | |
|---|---|---|---|
| Demographics at parent study baseline | |||
| Age, yrs | 53 ± 11.7 | 52 ± 12.2 | 53 ± 11.9 |
| Female | 405 (81.5) | 198 (81.8) | 603 (81.6) |
| Race | |||
| White | 374 (75.3) | 181 (74.8) | 555 (75.1) |
| Other | 119 (23.9) | 56 (23.1) | 175 (23.7) |
| Black or African American | 3 (0.6) | 3 (1.2) | 6 (0.8) |
| Asian | 1 (0.2) | 1 (0.4) | 2 (0.3) |
| Native Hawaiian or Pacific Islander | 0 | 1 (0.4) | 1 (0.1) |
| BMI, kg/m2 | 28.3 ± 5.74 | 27.6 ± 5.55 | 28.1 ± 5.69 |
| Geographic region | |||
| Latin America | 186 (37.4) | 75 (31.0) | 261 (35.3) |
| Central and Eastern Europe, EU | 136 (27.4) | 53 (21.9) | 189 (25.6) |
| Central and Eastern Europe, non-EU | 79 (15.9) | 73 (30.2) | 152 (20.6) |
| West and Asia Pacific | 96 (19.3) | 41 (16.9) | 137 (18.5) |
| Disease characteristics at parent study baseline | |||
| Duration of RA from diagnosis, yrsa | 8.3 ± 7.1 | 8.9 ± 7.1 | 8.5 ± 7.1 |
| RF-positive | 382 (76.9) | 180 (74.4) | 562 (76.0) |
| Anti-CCP-positive | 402 (80.9) | 192 (79.3) | 594 (80.4) |
| Prior exposure to bDMARDb | 48 (9.7) | 19 (7.9) | 67 (9.1) |
| Concurrent corticosteroids on first dosing date | 239 (48.1) | 143 (59.1) | 382 (51.7) |
| Concurrent MTX dose on first dosing date, mg/mL | 16.8 ± 4.2 | NA | 16.8 ± 4.2 |
Values are expressed as n (%) or mean ± SD.
↵a Duration of RA (yrs) = (first dose date in core studies – date of initial diagnosis + 1)/365.25.
↵b Patients were excluded from the parent studies if they had previous RA treatment with a bDMARD.
The only exception to this was if the biologic agent had been received in a single clinical study > 6 months prior to enrollment and if the drug had been effective.
bDMARD: biologic disease-modifying antirheumatic drug; CCP: cyclic citrullinated peptide; EU: European Union; MTX: methotrexate; NA: not applicable; RA: rheumatoid arthritis; RF: rheumatoid factor.