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Table 2 Primary (DAS28-ESR) and key secondary endpoints at day 85

From: Efficacy and safety of pateclizumab (anti-lymphotoxin-α) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study)

  Pateclizumab ADA Placebo
(n = 84) (n = 84) (n = 43)
DAS28(4)-ESR score at baseline
Mean (SD) 6.95 (0.89) 6.84 (0.90) 6.80 (0.74)
DAS28(4)-ESR score at day 85
Mean (SD) 5.06 (1.52) 4.31 (1.46) 5.26 (1.44)
DAS28(4)-ESR score change from baseline
Mean (SD) -1.89 (1.38) -2.52 (1.43) -1.54 (1.34)
P value of difference of change scorea
Versus placebo 0.5172 0.0004 -
Versus ADA 0.0003 - -
ACR20 response    
n (%) 50 (64.1%) 58 (77.3%) 17 (45.9%)
ACR50 response
n (%) 26 (33.3%) 43 (57.3%) 9 (24.3%)
ACR70 response
n (%) 11 (14.1%) 26 (34.7%) 3 (8.1%)
ACR components, mean (P value vs. placebob)
Swollen joint count -8.9 (0.04) -10.4 (<0.01) -6.1
Tender joint count -13.3 (0.10) -16.3 (<0.01) -9.8
Patient-s global VAS (mm) -28.8 (0.27) -37.0 (<0.01) -24.0
Physician-s global VAS (mm) -33.8 (<0.01) -34.1 (<0.01) -23.2
Patient's pain VAS -26.7 (0.24) -33.5 (<0.01) -21.6
CRP -0.5 (0.08) -1.2 (<0.01) 0.3
ESR -11.9 (0.47) -22.9 (0.04) -14.7
HAQ-DI -0.5 (0.09) -0.8 (<0.01) -0.3
  1. aP value from analysis of covariance; bP value for least squares mean change from baseline compared with placebo. ACR, American College of Rheumatology; ADA, adalimumab; CRP, C-reactive protein; DAS28(4), 4-variable, 28-joint disease activity score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire disability index; SD, standard deviation; VAS, visual analog scale (0 to 100).