Table 2

Efficacy results at week 24

VariableTCZ+MTX (N=277)TCZ+PBO (N=276)p Value (between group)
DAS28 remission rate, %40.434.80.19
Change in DAS28, mean (SD)−3.43 (1.33)−3.21 (1.31)0.051
LDAS, %61.751.40.029
EULAR good plus moderate responders, %89.586.20.30
ACR–EULAR Boolean remission rate, %6.95.40.53
SDAI remission rate (≤3.3), %11.99.80.56
CDAI remission rate (≤2.8), %11.97.60.12
Change in tender joint count, mean (SD)−17.25 (13.35)−17.00 (13.64)0.52
Change in swollen joint count, mean (SD)−11.33 (8.04)−11.75 (9.45)0.61
Change in patient's global assessment of disease activity, mean (SD)−34.3 (25.68)−32.4 (24.34)0.20
Change in physician's global assessment of disease activity, mean (SD)−40.7 (19.55)−38.5 (21.65)0.084
Change in patient's global assessment of pain, mean (SD)−29.3 (26.64)−29.8 (24.92)0.30
Change in RAQoL, mean (SD)−5.97 (7.95)−5.19 (7.06)0.31*
Change in total GSS, mean (SD)0.08 (1.88)0.22 (1.11)0.26
Change in JSN score, mean (SD)0.08 (1.48)0.11 (0.70)0.76
Change in erosion score, mean (SD)−0.01 (0.78)0.11 (0.63)0.066
Patients with no progression in GSS (≤SDC), %90.687.30.18
Patients with no progression in GSS (≤0), %65.759.10.088
  • ACR, American College of Rheumatology; CDAI, clinical disease activity index; DMARD, disease-modifying antirheumatic drug; DAS28, disease activity score based on 28 joints; EULAR, European League Against Rheumatism; GSS, Genant-modified Sharp score; JSN, joint space narrowing; LDAS, low disease activity score; MTX, methotrexate; PBO, placebo; RAQoL, rheumatoid arthritis quality of life questionnaire; SDAI, simplified disease activity index; SDC, smallest detectable change; TCZ, tocilizumab. *p Value from a 2-sided Wilcoxon rank-sum test of no difference between the two treatment arms.