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 factors | Overall | |||||
| 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, years | 51±12.9 | 53±12.9 | 50±12.8 | 53±12.9 | 52±12.9 | 53±13.6 |
| Female, n (%) | 133 (77.3) | 65 (76.5) | 67 (77.0) | 128 (77.1) | 393 (77.1) | 961 (76.9) |
| RA duration, years | 1.8±3.40 | 2.8±5.50 | 2.4±6.27 | 2.7±6.16 | 2.4±5.29 | 2.2±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/day | 6.9±2.44 | 7.2±2.59 | 6.5±2.09 | 6.3±2.31 | 6.7±2.37 | 6.6±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/L | 31.6±31.3 | 28.0±28.5 | 23.3±24.6 | 26.3±27.1 | 27.9±28.5 | 17.5±25.0 |
| mTSS erosions >0, n (%) | 172 (100) | 85 (100) | 87 (100) | 166 (100) | 510 (100) | 1173 (93.9) |
| SJC66 | 20±11.4 | 19±10.8 | 19±10.8 | 18±10.1 | 19±10.8 | 16.0±9.6 |
| TJC68 | 30±14.3 | 29±13.1 | 28±13.6 | 28±14.3 | 29±14.0 | 26.0±14.0 |
| Pain (VAS) | 73±17.0 | 73±19.0 | 72±16.4 | 73±17.0 | 73±17.2 | 65±21.3 |
| HAQ-DI | 1.73±0.59 | 1.79±0.63 | 1.72±0.69 | 1.81±0.55 | 1.76±0.60 | 1.56±0.634 |
| DAS28(CRP) | 6.4±0.73 | 6.3±0.72 | 6.2±0.67 | 6.3±0.72 | 6.3±0.72 | 5.7±0.99 |
| CDAI | 44.8±12.0 | 45.1±11.1 | 42.7±11.9 | 44.2±11.1 | 44.3±11.5 | 39.8±12.6 |
| SDAI | 47.9±12.3 | 47.9±11.8 | 45.0±11.7 | 46.8±11.8 | 47.1±11.9 | 41.5±13.4 |
| mTSS units* | 13.2±23.1 | 18.1±35.9 | 24.2±44.3 | 19.3±37.2 | 17.9±34.5 | 13.3±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.