Patient demographics and baseline characteristics*
| Placebo (n=170) | Peficitinib 100 mg (n=174) | Peficitinib 150 mg (n=174) | Peficitinib 100 mg +150 mg (n=348) | Total (n=518) | |
| Female, n (%) | 121 (71.2) | 118 (67.8) | 125 (71.8) | 243 (69.8) | 364 (70.3) |
| Age in years, mean (SD) | 55.3 (12.1) | 58.5 (10.8) | 56.2 (11.6) | 57.4 (11.2) | 56.7 (11.6) |
| <65 years, n (%) | 125 (73.5) | 116 (66.7) | 131 (75.3) | 247 (71.0) | 372 (71.8) |
| Body weight in kg, mean (SD) | 58.92 (13.30) | 57.39 (12.32) | 58.20 (12.49) | 57.79 (12.39) | 58.16 (12.70) |
| RA duration in years,† mean (SD) | 4.30 (2.93) | 4.41 (2.96) | 4.37 (3.09) | 4.39 (3.02) | 4.36 (2.99) |
| Tender joint count (68 joints),‡ mean (SD) | 15.4 (9.4) | 14.0 (8.6) | 14.5 (7.8) | 14.2 (8.2) | 14.6 (8.6) |
| Swollen joint count (66 joints),‡ mean (SD) | 13.6 (7.0) | 12.8 (6.8) | 13.1 (6.9) | 13.0 (6.8) | 13.2 (6.9) |
| Physician’s Global Assessment of Disease Activity (100 mm VAS),§ mean (SD) | 60.98 (19.59) | 58.87 (19.67) | 60.86 (19.09) | 59.87 (19.38) | 60.23 (19.43) |
| Subject’s Global Assessment of Disease Activity (100 mm VAS),§ mean (SD) | 58.18 (23.90) | 51.70 (25.25) | 55.44 (24.49) | 53.57 (24.91) | 55.07 (24.65) |
| Subject’s Global Assessment of Pain (100 mm VAS),§ mean (SD) | 56.75 (25.29) | 51.12 (26.14) | 55.09 (24.89) | 53.10 (25.56) | 54.30 (25.51) |
| mTSS,‡ mean (SD) | 28.40 (36.28) | 25.23 (35.50) | 25.00 (32.38) | 25.11 (33.92) | 26.19 (34.71) |
| Erosion score,‡ mean (SD) | 11.03 (17.96) | 10.34 (17.47) | 9.76 (15.93) | 10.05 (16.69) | 10.37 (17.11) |
| Joint space narrowing score,‡ mean (SD) | 17.37 (20.13) | 14.89 (19.47) | 15.23 (18.33) | 15.06 (18.88) | 15.82 (19.31) |
| DAS28-CRP,‡ mean (SD) | 5.41 (0.85) | 5.21 (0.94) | 5.36 (0.92) | 5.29 (0.93) | 5.33 (0.91) |
| DAS28-CRP ≤3.2, n (%) | 0 | 3 (1.7) | 3 (1.7) | 6 (1.7) | 6 (1.2) |
| DAS28-CRP >3.2–≤5.1, n (%) | 63 (37.3) | 76 (43.7) | 59 (33.9) | 135 (38.8) | 198 (38.3) |
| DAS28-CRP >5.1, n (%) | 106 (62.7) | 95 (54.6) | 112 (64.4) | 207 (59.5) | 313 (60.5) |
| Missing, n | 1 | 0 | 0 | 0 | 1 |
| DAS28-ESR,¶ mean (SD) | 6.05 (0.88) | 5.83 (0.99) | 5.98 (1.00) | 5.91 (1.00) | 5.95 (0.96) |
| DAS28-ESR ≤3.2, n (%) | 0 | 1 (0.6) | 1 (0.6) | 2 (0.6) | 2 (0.4) |
| DAS28-ESR >3.2–≤5.1, n (%) | 24 (14.2) | 30 (17.2) | 29 (16.8) | 59 (17.0) | 83 (16.1) |
| DAS28-ESR>5.1, n (%) | 145 (85.8) | 143 (82.2) | 143 (82.7) | 286 (82.4) | 431 (83.5) |
| Missing, n | 1 | 0 | 1 | 1 | 2 |
| HAQ-DI score,† mean (SD) | 1.05 (0.66) | 0.91 (0.65) | 1.02 (0.62) | 0.96 (0.64) | 0.99 (0.65) |
| CRP (mg/dL), mean (SD) | 2.622 (2.146) | 2.432 (2.076) | 2.524 (2.183) | 2.478 (2.127) | 2.525 (2.132) |
| ESR (mm/hr), mean (SD) | 53.8 (26.9) | 50.4 (26.2) | 51.5 (26.8) | 51.0 (26.5) | 51.9 (26.6) |
| CDAI score,‡ mean (SD) | 31.56 (10.60) | 29.88 (11.73) | 31.51 (11.39) | 30.69 (11.57) | 30.98 (11.26) |
| SDAI score,‡ mean (SD) | 34.18 (11.14) | 32.31 (12.26) | 34.03 (11.99) | 33.17 (12.14) | 33.50 (11.82) |
| Prior biological DMARD use, n (%) | 38 (22.4) | 33 (19.0) | 27 (15.5) | 60 (17.2) | 98 (18.9) |
| MTX dose at baseline mg/week, mean (SD) | 9.78 (3.08) | 10.09 (2.75) | 9.88 (2.81) | 9.99 (2.78) | 9.92 (2.88) |
| >0–≤8, n (%) | 84 (49.7) | 63 (36.6) | 76 (44.2) | 139 (40.4) | 223 (43.5) |
| >8–≤12, n (%) | 60 (35.5) | 88 (51.2) | 74 (43.0) | 162 (47.1) | 222 (43.3) |
| >12, n (%) | 25 (14.8) | 21 (12.2) | 22 (12.8) | 43 (12.5) | 68 (13.3) |
| Missing, n | 1 | 2 | 2 | 4 | 5 |
| Positive for anti-CCP antibodies,** % | 88.8 | 89.7 | 92.5 | 91.1 | 90.3 |
| Positive for rheumatoid factor,** % | 67.6 | 66.1 | 67.8 | 67.0 | 67.2 |
| Number of prior DMARDs (including biologicals) | |||||
| 1 | 56 (32.9) | 57 (32.8) | 66 (37.9) | 123 (35.3) | 179 (34.6) |
| 2 | 83 (48.8) | 90 (51.7) | 83 (47.7) | 173 (49.7) | 256 (49.4) |
| ≥3 | 31 (18.2) | 27 (15.5) | 25 (14.4) | 52 (14.9) | 83 (16.0) |
| Prior non-biological DMARD use, except for MTX, n (%) | 97 (57.1) | 105 (60.3) | 95 (54.6) | 200 (57.5) | 297 (57.3) |
*All values are n (mean) unless otherwise indicated.
†Duration of RA (years) was calculated as (date of baseline mTSS taken − onset date of RA + 1)/365.25.
‡Higher values indicate greater levels of disease activity.
§Possible VAS scores range from 0 to 100, with higher scores indicating greater disease activity.
¶Possible HAQ-DI scores range from 0 to 3, with higher scores indicating greater disability.
**Patients with ‘high positive’ readings, defined as 3 × upper limit of normal range.
CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28-CRP, disease activity score for 28 joints based on CRP; DAS28-ESR, disease activity score for 28 joints based on erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; RA, rheumatoid arthritis; SDAI, Simplified Disease Activity Index; mTSS, van der Heijde-modified total Sharp score.