Demographic and baseline characteristics (FAS population)
| Placebo (N=56) | Peficitinib 25 mg (N=55) | Peficitinib 50 mg (N=57) | Peficitinib 100 mg (N=55) | Peficitinib 150 mg (N=58) | p Value | |
|---|---|---|---|---|---|---|
| Age (years) | 54.2±12.1 | 52.9±9.5 | 54.2±11.6 | 52.1±12.1 | 51.6±12.1 | 0.655* |
| <65 years, n (%) | 45 (80.4) | 50 (90.9) | 45 (78.9) | 45 (81.8) | 51 (87.9) | NT |
| Female, n (%) | 43 (76.8) | 46 (83.6) | 46 (80.7) | 42 (76.4) | 51 (87.9) | 0.663† |
| BW (kg) | 58.31±10.92 | 58.85±12.10 | 55.13±11.61 | 55.89±13.08 | 55.29±9.54 | 0.268* |
| RA duration (years) | 6.92±5.39 | 8.03±8.12 | 6.69±5.52 | 7.58±7.12 | 6.95±5.17 | 0.789* |
| TJC (68 count) | 12.4±8.0 | 15.8±9.6 | 15.8±9.4 | 16.1±9.9 | 16.0±9.3 | 0.174* |
| SJC (66 count) | 10.9±4.5 | 12.1±5.5 | 11.2±5.3 | 13.7±8.4 | 12.9±6.5 | 0.099* |
| PGA (mm) | 54.01±20.30 | 57.15±18.88 | 56.74±20.96 | 59.45±21.73 | 59.36±21.41 | 0.622* |
| PtGA (mm) | 52.29±27.76 | 58.09±22.61 | 59.46±26.42 | 58.19±24.64 | 61.15±24.73 | 0.416* |
| Pain VAS (mm) | 53.05±27.10 | 55.82±22.95 | 59.16±26.38 | 57.14±25.32 | 60.57±24.22 | 0.550* |
| DAS28-CRP | 5.10±1.01 | 5.30±0.86 | 5.26±0.98 | 5.34±1.07 | 5.41±1.12 | 0.541* |
| DAS28-ESR‡ | 5.77±0.91 | 5.99±0.89 | 5.98±0.92 | 6.07±1.02 | 6.08±1.07 | 0.438* |
| HAQ-DI | 0.88±0.68 | 0.93±0.65 | 0.94±0.66 | 1.02±0.64 | 0.95±0.69 | 0.858* |
| CRP (mg/dL) | 2.54±2.36 | 2.40±2.69 | 2.14±2.32 | 2.59±2.84 | 2.41±2.05 | 0.888* |
| ESR (mm/hr) | 47.14±23.49 | 47.35±23.79 | 47.11±26.61 | 48.98±23.67 | 49.43±26.82 | 0.978* |
| Prior anti-TNF use, n (%) | 16 (28.6) | 11 (20.0) | 14 (24.6) | 14 (25.5) | 16 (27.6) | 0.940† |
| Prior MTX use, n (%) | 50 (89.3) | 49 (89.1) | 51 (89.5) | 47 (85.5) | 54 (93.1) | 0.906† |
Data are expressed as mean±SD unless otherwise noted.
*One way analysis of variance.
†χ2 test (continuity corrected).
‡N=56, 55, 57, 54 and 58 in the placebo, peficitinib 25 mg, 50 mg, 100 mg and 150 mg groups, respectively.
BW, body weight; CRP, C-reactive protein; DAS28-CRP, disease activity score using C-reactive protein; ESR, erythrocyte sedimentation rate; FAS, full analysis set; HAQ-DI, health assessment questionnaire-disability index; MTX, methotrexate; NT, not tested; PGA, physician's global assessment of arthritis; PtGA, patient's global assessment of arthritis; RA, rheumatoid arthritis; SJC, swollen joint count; TJC, tender joint count; TNF, tumour necrosis factor; VAS, visual analogue scale.