Takeaway
- Denosumab significantly inhibits the progression of joint destruction, increases bone mineral density (BMD) and is well tolerated in patients with rheumatoid arthritis (RA) receiving concomitant conventional synthetic disease-modifying antirheumatic drug (csDMARD).
Why this matters
- Denosumab has potential as a novel therapeutic option for suppression of bone erosion and bone loss in RA with or without concomitant osteoporosis, particularly in those who do not respond well to biological DMARDs.
Study design
- This study included 654 patients with RA receiving csDMARDs, who were randomly assigned (1:1:1) to receive denosumab 60 mg every 3 months (Q3M; n=219), 6 months (Q6M; n=217) or placebo (n=218).
- Primary outcomes: change in the modified total Sharp score (mTSS) from baseline to 12 months.
- Secondary outcomes: Changes in the bone erosion score, joint space narrowing (JSN), and per cent changes in the lumbar spine (L1-L4) BMD at 12 months.
- Funding: None disclosed.
Key results
- Mean changes in mTSS score from baseline to 12 months were significantly smaller in Q3M (0.72; 95% CI, 0.41-1.03; P=.0055) and Q6M (0.99; 95% CI, 0.49-1.49; P=.0235) group vs placebo group (1.49; 95% CI, 0.99-1.99).
- Mean changes in bone erosion score were 0.98 (95% CI, 0.65-1.31) in the placebo group, 0.51 (95% CI, 0.22-0.80) in the Q6M group (P=.0104) and 0.22 (95% CI, 0.09-0.34) in the Q3M group (P=.0001).
- No significant difference was observed JSN score between the groups.
- The per cent changes in the lumbar spine (L1-L4) BMD were significantly smaller in Q3M (4.88%) and Q6M (3.99%) group vs placebo group (-1.03%) (P<.0001 for all).
- No major differences were observed in safety profiles.
Limitations
- Prohibited concomitant use of biologics and tofacitinib.
- Short study duration.
References
References
