Table 1.
Baseline patient demographic and clinical characteristics (full analysis set)
| csDMARDs plus denosumab (N = 21) |
csDMARD therapy alone (N = 22) |
|
|---|---|---|
| Female sex | 18 (85.7) | 20 (90.9) |
| Age, years | 65.6 ± 8.5 | 65.0 ± 9.2 |
| ≥ 65 years | 12 (57.1) | 11 (50.0) |
| Body mass index, kg/m2 | 22.94 ± 3.42 | 22.64 ± 4.48 |
| Duration of rheumatoid arthritis, months | 162.3 ± 151.3 | 150.5 ± 129.0 |
| < 6 months | 1 (4.8) | 0 (0.0) |
| 6 to < 36 months | 4 (19.0) | 3 (14.3) |
| ≥ 36 months | 16 (76.2) | 18 (85.7) |
| Osteoporosis | 15 (71.4) | 11 (50.0) |
| Prior fracture | 5 (23.8) | 5 (22.7) |
| Medical history other than fracture | ||
| Knee arthroplasty | 1 (4.8) | 0 (0.0) |
| Tonsillectomy | 1 (4.8) | 0 (0.0) |
| Bone erosion (HR-pQCT of 2–3 metacarpal heads) | 8 (38.1) | 13 (59.1) |
| Anti-CCP antibody-positive | 16 (76.2) | 17 (77.3) |
| Rheumatoid factor-positive | 17 (81.0) | 18 (81.8) |
| Concomitant medications | ||
| Vitamin D and calcium | 21 (100.0) | 14 (63.6) |
| Bisphosphonates | 0 (0.0) | 4 (18.2) |
| Glucocorticoids | 10 (47.6) | 4 (18.2) |
| csDMARDs | 21 (100.0) | 22 (100.0) |
| Methotrexate | 19 (90.5) | 16 (72.7) |
| Salazosulfapyridine | 7 (33.3) | 3 (13.6) |
| Tacrolimus hydrate | 1 (4.8) | 3 (13.6) |
| Iguratimod | 1 (4.8) | 2 (9.1) |
| Bucillamine | 0 (0.0) | 3 (13.6) |
| DAS28-ESR | 3.064 ± 0.834 | 3.041 ± 0.879 |
Data are shown as n (%) or mean ± SD
CCP cyclic citrullinated peptide, csDMARD conventional synthetic disease-modifying anti-rheumatic drug, DAS28-ESR Disease Activity Score in 28 joints for rheumatoid arthritis with erythrocyte sedimentation rate, HR-pQCT high-resolution peripheral quantitative computed tomography, SD standard deviation