Background: RANK-ligand is essential for osteoclast development, activation, and survival. The aim of this study was to evaluate the effects of denosumab (monoclonal antibody that binds RANKL) on BMD, structural damage in patients with rheumatoid arthritis (RA) and osteoporosis (OP).
Methods: 29 postmenopausal women with RA and OP received s/c denosumab 60 mg injections every 6 months for 12 months. The primary endpoint was the change from baseline in the Sharp/van der Heijde (SVH) score, X-ray morphometric analysis of deformations in vertebrae (Genant method) and BMD (by dual energy X-ray absorptiometry) at three sites: lumbar spine (L1-L4), hip neck (HN) and distal forearm (DF) at 12 months. The Statistica 6.0 was used.
Results: The mean age was 58.2±7.5 years, the mean duration of RA 19.8±12.0 years. During the study 18 patients (62.1%) continued glucocorticoids (GC). According to X-ray 9 (31.0%) patients had the 2nd, 8 (27.6%) the 3rd and 12(41.4%) - the 4th stage of RA. Mean BMD (L1-L4) before after treatment was 0.796±0.088 g/cm2 and 0.830±0.088 g/cm2 (?<0.001), at HN was 0.627±0.077 g/?m2 and 0.635±0.079 g/?m2 (p>0.05), at DF was 0.484±0.100 g/?m2 and 0.498±0.092 g/?m2 (?=0.032), respectively. The significant increase of BMD was noted both in groups, receiving GC or not. The index of vertebral deformations at lumbar spine did not change: 0.79±0.03, at thoracic site was 0.77±0.04 and 0.76±0.04 (?>0.05), respectively. The erosion score and total SVH score were increased after treatment (?=0.043): 53.3±53.7 and 54.3±53.8, 156.1±84.7 and 157.3±85.0, respectively. The amount of narrowed cracks did not change significant: 102.7±37.1 and 103.0±37.1.
Conclusions: After 12 months denosumab therapy it was shown the significant increase of BMD in L1-L4 and forearm, the erosion score. The index of vertebral deformations remained stable.
Disclosure: The authors declared no competing interests.