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

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)
	Month	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
PD score in both hands by musculoskeletal ultrasound, %	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
mTSS by X-ray, %	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

ISSN: 1478-6362