The concurrent use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and denosumab was found to significantly suppress the progression of joint destruction in patients with RA, according to study results published in the Annals of the Rheumatic Diseases.
Researchers conducted a double-blind placebo-controlled randomized study of 654 patients with rheumatoid arthritis (RA) receiving csDMARD therapy. Study participants were randomly assigned in a 1:1:1 manner to receive a single 60 mg-dose of denosumab or placebo every 6 months or every 3 months. The primary study outcome was the difference in the modified total Sharp score (mTSS) from start of therapy to 12 months.
After analysis, the researchers found that the mean changes in the mTss at 12 months were 1.49 (95% CI, 0.99-1.99), 0.72 (95% CI, 0.41-1.03), and 0.99 (95% CI, 0.49-1.49) in the placebo, 3-month, and 6-month groups, respectively. Overall, they reported that patients in the denosumab arms showed significantly reduced progression of joint destruction.
With respect to safety, no major differences were noted between the groups.
One key limitation of the study was the short duration of follow-up.
“Denosumab inhibits the progression of joint destruction, increases bone mineral density and is well tolerated in patients with RA taking csDMARD,” the investigators concluded.
Takeuchi T, Tanaka Y, Soen S, et al. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial [published online April 29, 2019]. Ann Rheum Dis. doi:10.1136/annrheumdis-2018-214827