Table 4.
Change from baseline in other exploratory endpoints evaluated by MRI, musculoskeletal ultrasound, and X-ray (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 |
||
| Total osteitis score of the metacarpal heads and wrist joints by MRI, % | 6 | 17 | 7.45 [− 55.95, 70.86] | 18 | 28.87 [− 38.70, 96.44] |
− 21.42 [− 97.14, 54.30] P = 0.5725 |
| 12 | 16 | 47.79 [− 18.34, 113.92] | 17 | 21.75 [− 46.33, 89.84] |
26.04 [− 51.02, 103.09] P = 0.5006 |
|
| Bone erosion score of the metacarpal heads and wrist joints by MRI, % | 6 | 18 | 4.49 [− 12.67, 21.64] | 19 | 5.16 [− 11.69, 22.02] |
− 0.68 [− 19.81, 18.45] P = 0.9438 |
| 12 | 16 | 13.42 [− 4.89, 31.72] | 18 | 20.07 [3.04, 37.09] |
− 6.65 [− 26.65, 13.35] P = 0.5085 |
|
| PD score in both hands by musculoskeletal ultrasound, % | 6 | 14 | 37.61 [− 36.73, 111.95] | 15 | 41.50 [− 36.00, 118.99] |
− 3.88 [− 90.12, 82.35] P = 0.9271 |
| 12 | 13 | 36.57 [− 39.34, 112.48] | 15 | 23.75 [− 53.75, 101.24] |
12.82 [− 74.02, 99.67] P = 0.7645 |
|
| mTSS by X-ray, % | 6 | 19 | − 1.66 [− 15.89, 12.57] | 20 | 2.51 [− 11.53, 16.55] |
− 4.17 [− 20.16, 11.82] P = 0.6044 |
| 12 | 18 | 10.05 [− 5.05, 25.14] | 19 | 7.97 [− 6.24, 22.18] |
2.08 [− 14.42, 18.57] P = 0.8024 |
|
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, MRI magnetic resonance imaging, mTSS modified total Sharp score, PD power Doppler