Table 1 Baseline Clinical Characteristics
Baseline Clinical Characteristics, Mean (SD) | FUNCTION Biomarker Population(n = 458) | LITHE Biomarker Population(n = 287) | P Value* | FUNCTION ITT Population | LITHE ITT Population | |||
|---|---|---|---|---|---|---|---|---|
TCZ 8 mg/kg Monotherapy(n = 292) | TCZ 8 mg/kg + MTX(n = 290) | PBO + MTX(n = 287) | TCZ 8 mg/kg + MTX(n = 398) | PBO + MTX(n = 393) | ||||
Disease duration, years | 0.45 (0.50) | 8.65 (7.80) | < 0.0001 | 0.5 (0.48) | 0.5 (0.53) | 0.4 (0.48) | 9.3 (8.2) | 9.0 (8.1) |
TJC68 | 28.8 (16.9) | 29.0 (15.5) | 0.5594 | 28.7 (16.3) | 28.7 (16.7) | 27.4 (16.5) | 29.3 (15.2) | 27.9 (14.8) |
SJC66 | 17.3 (11.5) | 16.4 (9.5) | 0.4889 | 16.5 (10.1) | 17.6 (12.4) | 16.2 (10.4) | 17.3 (9.5) | 16.6 (9.2) |
DAS28-ESR | 6.7 (1.0) | 6.5 (0.9) | 0.0013 | 6.7 (1.0) | 6.7 (1.1) | 6.6 (1.0) | 6.6 (1.0) | 6.5 (1.0) |
ESR, mm/h | 53.0 (28.8) | 43.1 (21.4) | < 0.0001 | 51.3 (28.4) | 52.8 (30.2) | 50.4 (26.8) | 46.3 (24.8) | 46.4 (24.7) |
CRP, mg/dL | 2.5 (2.8) | 2.1 (2.5) | 0.2702 | 2.5 (3.2) | 2.6 (3.0) | 2.3 (2.7) | 2.3 (2.6) | 2.2 (2.5) |
PGA, 100-mm VAS | 63.0 (18.8) | 62.6 (16.9) | 0.7807 | 63.9 (18.1) | 63.6 (18.1) | 62.7 (17.3) | 62.7 (16.9) | 63.1 (17.3) |