Improvements in GUSS, a validated tool developed to identify changes in hand osteoarthritis over time, were higher in the denosumab group when compared with placebo and the development of new erosive joints was significantly lower at week 48.
The structure modifying effect of subcutaneous denosumab, a drug that has been shown to affect bone resorption and osteoclast activity, was evaluated in patients with erosive hand osteoarthritis to explore the clinical benefits and safety of the drug compared with placebo. Results of the study indicated that the drug had significant structure modifying effects in this patient population, with significantly less erosive progression and symptom improvement after 24 weeks of treatment, with further enhancements reported at 48 weeks.
Rheumatology Network interviewed Ruth Wittoek, MD, PhD, to discuss the study “Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase,” presented at the American College of Rheumatology (ACR) Convergence 2022. Wittoek is a professor of rheumatology at Ghent University Hospital, in Belgium.
During the trial, 100 patients were randomly assigned to receive either denosumab or placebo, followed by an open-label extension through week 96. Improvements in Ghent University Scoring System (GUSS), a validated tool developed to identify changes in hand osteoarthritis over time, were higher in the denosumab group when compared with placebo (mean change GUSS = 8.9 [95% CI: 1.0 – 16.9; p = 0.024]) and the development of new erosive joints was significantly lower (1.8%) when compared with placebo (7.0%) at week 48.
“We want to know why receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibition is so important in erosive hand osteoarthritis,” Wittoek emphasized. “We think that RANKL plays a role in developing or changing the phenotype of specific fibroblasts and, therefore, we are doing some more basic research to prototype or identify these kinds of fibroblasts. Of course, we need to confirm our results and we hope to do in phase 3, probably multicentric, randomized clinical trial again with denosumab.”