Table 1.
Patient demographics and baseline characteristics (SAF)
| Placebo (N=101) | Peficitinib 100 mg (N=104) | Peficitinib 150 mg (N=102) | Peficitinib 100 mg +150 mg (N=206) | Etanercept (open-label arm) (N=200) | Total (N=507) | |
| Female, n (%) | 73 (72.3) | 77 (74.0) | 78 (76.5) | 155 (75.2) | 138 (69.0) | 366 (72.2) |
| Age in years, mean (SD) | 56.3 (11.7) | 54.1 (12.2) | 55.0 (12.8) | 54.5 (12.5) | 55.5 (11.6) | 55.3 (12.0) |
| <65 years, n (%) | 71 (70.3) | 83 (79.8) | 75 (73.5) | 158 (76.7) | 154 (77.0) | 383 (75.5) |
| Study region, n (%) | ||||||
| Japan | 83 (82.2) | 85 (81.7) | 83 (81.4) | 168 (81.6) | 164 (82.0) | 415 (81.9) |
| Korea | 10 (9.9) | 11 (10.6) | 11 (10.8) | 22 (10.7) | 22 (11.0) | 54 (10.7) |
| Taiwan | 8 (7.9) | 8 (7.7) | 8 (7.8) | 16 (7.8) | 14 (7.0) | 38 (7.5) |
| Body weight in kg, mean (SD) | 58.52 (13.00) | 59.90 (12.35) | 57.69 (11.35) | 58.81 (11.89) | 58.29 (12.34) | 58.54 (12.27) |
| RA duration in years, mean (SD) | 6.98 (6.57) | 8.75 (7.12) | 10.39 (8.23) | 9.56 (7.71) | 9.17 (8.00) | 8.89 (7.66) |
| Tender joint count (68-joint), mean (SD) | 16.2 (10.7) | 15.0 (9.4) | 15.4 (9.5) | 15.2 (9.4) | 14.9 (9.3) | 15.3 (9.6) |
| Swollen joint count (66-joint), mean (SD) | 12.9 (7.2) | 12.4 (6.3) | 12.8 (7.1) | 12.6 (6.7) | 11.9 (6.8) | 12.4 (6.8) |
| Physician's Global Assessment of disease activity (100 mm VAS), mean (SD) | 61.93 (19.35) | 60.21 (20.11) | 58.46 (19.35) | 59.34 (19.71) | 58.17 (19.87) | 59.39 (19.71) |
| Subject’s Global Assessment of disease activity (100 mm VAS), mean (SD) | 58.99 (25.70) | 57.54 (24.78) | 59.52 (25.73) | 58.52 (25.21) | 57.52 (26.92) | 58.22 (25.95) |
| Subject’s Global Assessment of Pain (100 mm VAS), mean (SD) | 57.56 (25.07) | 57.31 (26.71) | 58.02 (25.66) | 57.67 (26.13) | 55.79 (26.54) | 56.90 (26.05) |
| DAS28-CRP, mean (SD) | 5.43 (1.03) | 5.29 (0.98) | 5.41 (0.96) | 5.35 (0.97) | 5.27 (0.94) | 5.33 (0.97) |
| DAS28-ESR, mean (SD) | 6.03 (1.13) | 5.94 (1.07) | 6.01 (1.03) | 5.98 (1.05) | 5.87 (1.09) | 5.94 (1.08) |
| HAQ-DI score, mean (SD) | 1.00 (0.66) | 0.92 (0.69) | 1.03 (0.67) | 0.97 (0.68) | 1.03 (0.75) | 1.00 (0.70) |
| CRP (mg/dL), mean (SD) | 2.258 (2.224) | 2.296 (2.566) | 2.561 (2.597) | 2.428 (2.579) | 2.055 (2.144) | 2.247 (2.346) |
| ESR (mm/hr), mean (SD) | 47.9 (27.6) | 49.6 (27.4) | 50.6 (29.7) | 50.1 (28.5) | 47.4 (29.8) | 48.6 (28.8) |
| SDAI score, mean (SD) | 35.48 (12.95) | 33.57 (12.71) | 34.15 (12.78) | 33.86 (12.72) | 32.91 (12.09) | 33.81 (12.53) |
| CDAI score, mean (SD) | 33.21 (12.14) | 31.27 (11.40) | 31.59 (11.97) | 31.43 (11.66) | 30.86 (11.40) | 31.56 (11.67) |
| Prior non-biological DMARD use only, n (%) | 90 (89.1) | 90 (86.5) | 89 (87.3) | 179 (86.9) | 162 (81.0) | 431 (85.0) |
| Prior biological DMARD use only, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Prior non-biological and biological DMARD use, n (%) | 11 (10.9) | 14 (13.5) | 13 (12.7) | 27 (13.1) | 38 (19.0) | 76 (15.0) |
| Prior MTX use, n (%) | 89 (88.1) | 94 (90.4) | 92 (90.2) | 186 (90.3) | 179 (89.5) | 454 (89.5) |
| Number of prior DMARDs (including biologicals), n (%) | ||||||
| 1 | 14 (13.9) | 19 (18.3) | 16 (15.7) | 35 (17.0) | 24 (12.0) | 73 (14.4) |
| 2 | 56 (55.4) | 57 (54.8) | 57 (55.9) | 114 (55.3) | 109 (54.5) | 279 (55.0) |
| ≥3 | 31 (30.7) | 28 (26.9) | 29 (28.4) | 57 (27.7) | 67 (33.5) | 155 (30.6) |
| Concomitant DMARD at baseline, n (%) | 87 (86.1) | 91 (87.5) | 89 (87.3) | 180 (87.4) | 176 (88.0) | 443 (87.4) |
| MTX | 57 (56.4) | 63 (60.6) | 62 (60.8) | 125 (60.7) | 117 (58.5) | 299 (59.0) |
| DMARD except for MTX only | 30 (29.7) | 28 (26.9) | 27 (26.5) | 55 (26.7) | 59 (29.5) | 144 (28.4) |
| None | 14 (13.9) | 13 (12.5) | 13 (12.7) | 26 (12.6) | 24 (12.0) | 64 (12.6) |
| MTX dose at baseline, mg/week | 11.35 (3.82) | 11.28 (2.98) | 10.77 (3.16) | 11.03 (3.07) | 11.12 (3.78) | 11.13 (3.50) |
| Prior biological DMARD-IR | 5 (5.0) | 9 (8.7) | 7 (6.9) | 16 (7.8) | 15 (7.5) | 36 (7.1) |
CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS, disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire - Disability Index; IR, inadequate response; MTX, methotrexate; RA, rheumatoid arthritis; SAF, safety analysis set; SDAI, Simplified Disease Activity Index; VAS, visual analogue scale.