Table 5.
Change from baseline in DAS28-ESR results (full analysis set)
| 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 |
|
Data are shown as adjusted mean [95% CI] unless otherwise indicated
N is the number of patients with available data
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
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