Table 1. Patient baseline demographics and disease characteristics.
Characteristic, Mean | Tofacitinib | |||||
---|---|---|---|---|---|---|
1 mg BID (n = 53) | 3 mg BID (n = 53) | 5 mg BID (n = 52) | 10 mg BID (n = 53) | 15 mg BID (n = 54) | Placebo (n = 52) | |
Age, years (SD) | 53.3 (9.9) | 52.8 (11.6) | 52.6 (10.9) | 54.7 (10.8) | 53.6 (12.5) | 53.3 (11.4) |
Male, n (%) | 11 (20.8) | 6 (11.3) | 8 (15.4) | 9 (17.0) | 10 (18.5) | 9 (17.3) |
Weight, kg (SD) | 52.9 (9.4) | 54.1 (10.2) | 54.2 (6.6) | 54.1 (10.0) | 53.8 (9.9) | 57.4 (11.7) |
BMI, kg/m2 (SD) | 21.5 (3.2) | 21.9 (3.8) | 22.2 (2.9) | 21.9 (3.9) | 22.1 (3.2) | 22.8 (3.8) |
Duration of RA, years (range) | 8.1 (0.5–39.0) | 6.8 (0.6–28.0) | 11.0 (0.4–34.0) | 7.3 (0.5–45.0) | 7.4 (0.5–38.3) | 6.4 (0.5–38.0) |
Tender joint count (SD) | 13.55 (7.98) | 17.26 (11.44) | 18.58 (13.02) | 17.13 (10.27) | 17.35 (8.96) | 15.10 (8.76) |
Swollen joint count (SD) | 11.30 (6.49) | 14.64 (10.09) | 15.31 (10.83) | 13.77 (7.66) | 14.48 (8.99) | 11.96 (5.69) |
PGA, mm (SD) | 60.30 (22.40) | 60.28 (19.92) | 68.77 (22.28) | 64.91 (21.25) | 68.33 (18.79) | 58.13 (25.27) |
PtGA, mm (SD) | 60.62 (22.19) | 59.57 (18.83) | 70.44 (19.85) | 64.53 (22.51) | 67.00 (19.97) | 58.38 (21.83) |
Patient pain assessment, mm (SD) | 61.57 (17.37) | 62.13 (18.09) | 71.13 (17.54) | 69.85 (15.21) | 66.93 (17.60) | 61.08 (16.79) |
HAQ-DI (SD) | 1.25 (0.59) | 1.19 (0.64) | 1.50 (0.69) | 1.20 (0.65) | 1.20 (0.69) | 1.21 (0.69) |
CRP, mg/L (SD) | 30.21 (28.40) | 25.65 (24.54) | 35.61 (34.15) | 26.88 (27.81) | 27.37 (35.69) | 24.01 (23.01) |
DAS28-4(ESR) (SD) | 6.04 (0.89) | 6.08 (1.04) | 6.41 (1.05) | 6.06 (0.92) | 6.20 (1.02) | 5.83 (0.93) |
BID twice daily, BMI body mass index, CRP C-reactive protein, DAS28-4(ESR) 28-joint disease activity score using erythrocyte sedimentation rate, HAQ-DI health assessment questionnaire-disability index, PGA physician global assessment, PtGA patient global assessment, RA rheumatoid arthritis, SD standard deviation.