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Table 5 Change from baseline in DAS28-ESR results (full analysis set)

From: Inhibition of bone erosion, determined by high-resolution peripheral quantitative computed tomography (HR-pQCT), in rheumatoid arthritis patients receiving a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) plus denosumab vs csDMARD therapy alone: an open-label, randomized, parallel-group study

 

Month

csDMARDs plus denosumab

(N = 21)

csDMARD therapy alone

(N = 22)

Difference (csDMARDs plus denosumab − csDMARD therapy alone)

N

Adjusted mean [95% CI]

N

Adjusted mean [95% CI]

Adjusted mean [95% CI]

P value

DAS28-ESR

6

21

− 0.56 [− 1.08, − 0.05]

21

− 0.54 [− 1.08, − 0.01]

− 0.02 [− 0.60, 0.56]

P = 0.9470

12

19

− 0.79 [− 1.32, − 0.26]

21

− 0.31 [− 0.84, 0.23]

− 0.48 [− 1.07, 0.11]

P = 0.1087

  1. Data are shown as adjusted mean [95% CI] unless otherwise indicated
  2. N is the number of patients with available data
  3. For adjusted mean, a linear mixed effect model analysis was performed using treatment group, sex, anti-CCP antibody (positive vs negative), baseline DAS28-ESR, measurement time point, and the interaction between the treatment group and measurement time point as fixed effects; patients as random effects; and baseline values as covariates
  4. CCP cyclic citrullinated peptide, CI confidence interval, csDMARD conventional synthetic disease-modifying anti-rheumatic drug, DAS28-ESR Disease Activity Score in 28 joints for rheumatoid arthritis with erythrocyte sedimentation rate