Baseline patient demographics, disease characteristics and treatment history
| Filgotinib once daily | ||||
|---|---|---|---|---|
| Placebo N=72 | 50 mg N=72 | 100 mg N=70 | 200 mg N=69 | |
| Patient demographics | ||||
| Age, mean (SE), years | 52 (1.4) | 52 (1.6) | 53 (1.4) | 52 (1.4) |
| Female, n (%) | 56 (77.8) | 62 (86.1) | 53 (75.7) | 60 (87.0) |
| Disease characteristics | ||||
| Duration of RA, mean (SE), years | 10 (0.8) | 9 (0.8) | 9 (0.8) | 9 (1.0) |
| Anti-CCP positive, n (%) | 58 (80.6) | 56 (77.8) | 54 (77.1) | 57 (82.6) |
| RF positive, n (%) | 57 (79.2) | 53 (73.6) | 51 (72.9) | 50 (72.5) |
| DAS28 (CRP), mean (SE) | 6.22 (0.099) | 6.03 (0.105) | 6.18 (0.101) | 6.09 (0.102) |
| CDAI, mean (SE) | 42 (1.3) | 41 (1.5) | 44 (1.5) | 42 (1.4) |
| SDAI, mean (SE) | 46 (1.5) | 44 (1.6) | 47 (1.7) | 44 (1.5) |
| ACR components | ||||
| CRP, mean (SE), mg/L | 35.26 (4.434) | 24.67 (3.257) | 25.55 (4.247) | 23.16 (2.492) |
| TJC68, mean (SE) | 25.23 (1.480) | 25.58 (1.620) | 27.20 (1.770) | 26.24 (1.506) |
| TJC28, mean (SE) | 15.85 (0.715) | 15.30 (0.790) | 16.52 (0.820) | 16.58 (0.750) |
| SJC66, mean (SE) | 15.98 (0.853) | 16.97 (1.074) | 18.65 (1.418) | 15.74 (1.047) |
| SJC28, mean (SE) | 12.18 (0.596) | 12.55 (0.710) | 13.19 (0.760) | 11.58 (0.654) |
| HAQ-DI total score, mean | 1.80 (0.058) | 1.84 (0.068) | 1.81 (0.068) | 1.80 (0.063) |
| Patient’s global assessment, mean (SE) | 71.1 (2.02) | 68.6 (2.41) | 71.5 (2.23) | 68.9 (2.07) |
| Investigator’s global assessment, mean (SE) | 70.4 (1.73) | 68.2 (1.73) | 72.0 (1.59) | 67.7 (1.86) |
| Patient’s pain, mean (SE) | 71.6 (2.37) | 71.0 (2.38) | 72.6 (1.85) | 68.1 (2.35) |
| Treatments | ||||
| Corticosteroids, n (%) | 45 (62.5) | 47 (65.3) | 50 (71.4) | 47 (68.1) |
| Duration of corticosteroid use, mean (SE), years | 4.59 (0.791) | 5.31 (0.771) | 3.39 (0.528) | 5.41 (0.757) |
| Previous biological DMARD use, n (%) | 3 (4.2) | 7 (9.7) | 4 (5.7) | 5 (7.2) |
| Previous conventional DMARD use*, n (%) | 71 (98.6) | 70 (97.2) | 68 (97.1) | 67 (97.1) |
| MTX, n (%) | 60 (83.3) | 61 (84.7) | 59 (84.3) | 58 (84.1) |
| MTX-sodium, n (%) | 5 (6.9) | 4 (5.6) | 7 (10.0) | 6 (8.7) |
| Duration of prior MTX use, mean (SE), years | 4.86 (0.656) | 4.44 (0.557) | 3.55 (0.464) | 3.85 (0.435) |
*Patients had MTX washed out for ≥4 weeks before or during screening.
ACR, American College of Rheumatology; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Score based on 28 joints; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; N, number of patients per treatment group; n, number of patients per category; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simple Disease Activity Index; SJC28, swollen joint count based on 28 joints; SJC66, swollen joint count based on 66 joints; TJC28, tender joint count based on 28 joints; TCJ68, tender joint count based on 68 joints.