For patients with rheumatoid arthritis (RA) who are positive for rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), or other risk factors, denosumab may be useful for inhibiting bone erosion, according to results published in Rheumatology.
The study included participants with RA taking methotrexate from the dose-response Denosumab in Patients With Rheumatoid Arthritis on Methotrexate to Validate Inhibitory Effect on Bone Erosion study (DRIVE study; n=340). Participants were randomly assigned to receive placebo or denosumab 60 mg every 2, 3, or 6 months.
After 12 months of follow-up, the researchers found that denosumab significantly inhibited the progression of bone erosion compared with placebo. In the placebo group, the mean changes in the modified Sharp erosion score from baseline were 1.18 for RF-positive participants and 0.59 for RF-negative patients.
For participants in the 6-month denosumab group, the mean changes were 0.25 for RF-positive (P =.0601 vs placebo) and 0.31 for RF-negative (P =.0827). For participants in the 3-month denosumab group, the mean changes were 0.21 for RF-positive (P =.0422 vs placebo) and −0.02 for RF-negative (P =.0631). For participants in the 2-month denosumab group, the mean changes were 0.15 for RF-positive (P =.0010 vs placebo) and −0.05 for RF-negative (P =.0332).
The researchers also calculated the mean changes in the erosion score according to the ACPA status (ACPA-positive vs ACPA-negative subgroups). These were 1.30 vs 0.07, 0.26 (P =.0142) vs 0.33 (P =.2748), 0.16 (P =.0058) vs 0.08 (P =.7166), and 0.09 (P <.0001) vs 0.08 (P =.8939), respectively, for placebo, 6-month denosumab, 3-month denosumab, and 2-month denosumab.
“RF and ACPA are poor prognostic factors and denosumab is a potentially useful treatment option for RA patients receiving [methotrexate] with these factors,” the researchers wrote.
Funding: This work was supported by Daiichi-Sankyo Co., Ltd. The sponsor was involved in the study conception, design, conduct, data collection, and data analyses.
Ishiguro N, Tanaka Y, Yamanaka H, et al. Efficacy of denosumab with regard to bone destruction in prognostic subgroups of Japanese rheumatoid arthritis patients from the phase II DRIVE study [published online January 2, 2019]. Rheumatology. doi: 10.1093/rheumatology/key416