Baseline patient demographics, disease characteristics and treatment history (safety population)
| Filgotinib once-daily dose groups | Filgotinib twice-daily dose groups | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (N=86) | 50 mg (N=82) | 100 mg (N=85) | 200 mg (N=86) | 2×25 mg (N=86) | 2×50 mg (N=85) | 2×100 mg (N=84) | |
| Patient demographics | |||||||
| Age, mean (SE), years | 52 (1.4) | 53 (1.5) | 52 (1.4) | 55 (1.3) | 52 (1.4) | 55 (1.3) | 54 (1.3) |
| Female, n (%) | 70 (81.4) | 69 (84.1) | 65 (76.5) | 74 (86.0) | 68 (79.1) | 65 (76.5) | 70 (83.3) |
| Disease characteristics | |||||||
| Duration of RA, mean (SE), years | 8 (0.8) | 7 (0.6) | 8 (0.7) | 9 (0.9) | 9 (0.8) | 8 (0.7) | 10 (1.0) |
| Anti-CCP positive, n (%) | 72 (83.7) | 64 (78.0) | 60 (70.6) | 69 (80.2) | 70 (82.4) | 70 (82.4) | 68 (81.0) |
| RF positive, n (%) | 65 (76.5) | 64 (78.0) | 57 (67.1) | 65 (75.6) | 66 (76.7) | 64 (75.3) | 65 (77.4) |
| DAS28 (CRP), mean (SE) | 5.98 (0.088) | 6.08 (0.093) | 6.14 (0.091) | 6.22 (0.088) | 6.05 (0.086) | 6.10 (0.098) | 6.14 (0.090) |
| CDAI, mean (SE) | 42 (1.2) | 41 (1.2) | 43 (1.3) | 43 (1.3) | 41 (1.2) | 42 (1.3) | 42 (1.2) |
| SDAI, mean (SE) | 44 (1.3) | 44 (1.3) | 45 (1.4) | 46 (1.3) | 44 (1.3) | 45 (1.4) | 45 (1.3) |
| ACR components | |||||||
| CRP, mean (SE), mg/L | 16.25 (1.567) | 27.71 (3.235) | 24.54 (2.849) | 27.10 (2.780) | 26.01 (3.142) | 24.60 (2.627) | 26.86 (2.729) |
| TJC68, mean (SE) | 24.98 (1.345) | 24.91 (1.499) | 25.32 (1.490) | 28.84 (1.650) | 25.43 (1.420) | 27.16 (1.546) | 25.95 (1.525) |
| SJC66, mean (SE) | 16.13 (0.8990) | 17.02 (1.116) | 16.31 (0.9387) | 17.36 (0.958) | 15.66 (0.8839) | 17.53 (1.124) | 16.36 (0.9372) |
| HAQ-DI total score, mean (SE) | 1.692 (0.0576) | 1.705 (0.0690) | 1.700 (0.0687) | 1.764 (0.0606) | 1.696 (0.0515) | 1.779 (0.0611) | 1.775 (0.0707) |
| Patient's global assessment, mean (SE) | 64.2 (1.96) | 68.2 (2.23) | 67.6 (2.09) | 68.7 (2.09) | 64.3 (1.95) | 65.7 (1.92) | 66.6 (2.20) |
| Investigator‘s global assessment, mean (SE) | 66.5 (1.62) | 66.2 (1.55) | 66.4 (1.67) | 65.8 (1.79) | 63.4 (1.59) | 66.6 (1.71) | 64.6 (1.72) |
| Patient's pain (VAS), mean (SE) | 65.7 (2.16) | 66.9 (2.20) | 65.4 (2.41) | 67.0 (2.16) | 65.7 (2.23) | 67.8 (2.12) | 67.2 (2.19) |
| Treatments | |||||||
| Methotrexate dose, mean (SE), mg/week | 16.5 (0.46) | 16.4 (0.45) | 16.6 (0.44) | 17.3 (0.47) | 17.5 (0.53) | 16.7 (0.45) | 17.3 (0.43) |
| Methotrexate duration, mean (SE), years | 5 (0.4) | 5 (0.5) | 6 (0.6) | 5 (0.6) | 5 (0.6) | 5 (0.6) | 4 (0.5) |
| Corticosteroids, n (%) | 50 (58.1) | 48 (58.5) | 47 (55.3) | 49 (57.0) | 51 (59.3) | 57 (67.1) | 50 (59.5) |
| Previous bDMARDs, n (%) | 8 (9.3) | 6 (7.3) | 6 (7.1) | 11 (12.8) | 6 (7.0) | 6 (7.1) | 7 (8.3) |
No significant differences for all parameters apart from a trend towards (non-significant, p=0.0555) lower mean CRP in the placebo group.
ACR, American College of Rheumatology; bDMARD, biological disease-modifying antirheumatic drugs; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; DAS28 (CRP), Disease Activity Score based on 28 joints and C reactive protein value; HAQ-DI, Health Assessment Questionnaire-Disability Index; N, number of patients per treatment group; n, number of patients per category; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simple Disease Activity Index; SJC66, swollen joint count based on 66 joints; TJC68, tender joint count based on 68 joints; VAS, visual analogue score.