Background RANK-ligand is essential for osteoclast development, activation, and survival. Denosumab (DMB), an antiosteoporotic drug, is a monoclonal antibody that binds RANKL. The addition of antiresorption preparations to the traditional scheme of rheumatoid arthritis (RA) treatment – the perspective direction of prevention and treatment of osteoporosis (OP) and control of erosive and destructive changes (control of local and generalized bone loss).
Objectives The aim of our study was to evaluate the dynamics of BMD, structural damage in hands, feet and vertebrae after 12-months of treatment with DMB in patients with RA and OP.
Methods 52 postmenopausal women with RA and OP received subcutaneously denosumab 60 mg injections every 6 months for 12 months. The primary end point was the change from baseline in the Sharp/van der Heijde (SVH) score by X-ray of hands and feet, X-ray morphometric analysis of deformations in vertebrae (Genant method) and BMD (by dual energy x-ray absorptiometry (DXA) at three sites: lumbar spine (L1-L4), hip neck (HN) and distal forearm (DF) at 12 months. The change of pain severity in spine (using VAS) also was assessed. The Statistica 6.0 was used.
Results The mean age was 58,4±6,4 years, the mean duration of RA 19,0±10,9 years. During the study 30 patients (58%) continued glucocorticoids (GC). According to X-ray 15 (29%) patients had the 2nd, 17 (33%) – the 3rd and 20 (38%) - the 4th stage of RA.
Mean BMD (L1-L4) before/after the treatment was 0,814±0,101 g/cm2 and 0,848±0,103 g/cm2 (p<0.001), at HN was 0,629±0,089 g/cm2 and 0,641±0,090 g/cm2 (p=0,02). At DF was 0,497±0,094 g/cm2 and 0,502±0,091 g/cm2 (p>0,05), respectively.
The significant increase of BMD (L1-L4) was noted both in groups, receiving GC or not.
The index of vertebral deformations at lumbar site of spine did not change after treatment – 0.78±0.04, similar trend was seen at thoracic site: before - 0,77±0,07 and after - 0,76±0,07 (p>0,05).
The erosion score, the amount of narrowed cracks and total SVH score were increased after treatment: 47.7 (M 29.0; 9.5–80.5) and 48.4 (M 29.0; 10.5–83.0) (p=0.017), 98.7 (M 109.0; 72.5–132.5) and 99.1 (M 109.0; 72.5–132.5) (p=0.043), 146.5 (M 135.0; 84.0–212.5) and 147.5 (M 135.0; 85.0–216.0) (p=0.017), respectively. Interesting to note, that after separation of groups based on GC intake, the increase of erosion score and total SVH score was only seen in patients taking GC. Patients without GC therapy did not show the negative dynamic.
At baseline 18 patients had pain in thoracic site of spine, while after treatment their number decreased more that 2-fold - 6 (mean VAS 42.5±17.9 and 33.3±10.8 mm, respectively), at lumbar spine pain was significantly (p=0.02) reduced: 29 and 22 patients (50.3±21.7 and 36.3±14.0 mm, respectively).
Conclusions After 12 months of therapy with denosumab it was shown the significant increase of BMD in L1-L4, HN, and stabilization in the forearm. The erosion score, the amount of narrowed cracks and total SVH score were increased after treatment, the increase of erosion score and total SVH score was only in patients with GC. The index of vertebral deformations remained stable. The frequency and severity of spine pain were decreased.
Disclosure of Interest None declared