Compared with risedronate, denosumab was found to improve bone mineral density (BMD) in patients with glucocorticoid-induced osteoporosis and rheumatoid arthritis (RA); however, the safety profile was similar between both treatments, according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021.
The current post hoc subgroup analysis included patients with glucocorticoid-induced osteoporosis and RA who were either initiating or continuing glucocorticoid therapy (≥7.5 mg daily prednisone or equivalent for <3 and ≥3 months before screening, respectively). The study cohort was randomly assigned to receive denosumab (60 mg every 6 months) or risedronate (5 mg once daily) for 24 months.
The primary outcome was a greater increase from baseline in the lumbar spine BMD at 12 months among patients receiving denosumab vs risedronate.
As secondary objectives, the researchers assessed changes from baseline in BMD at lumbar spine, total hip, and femoral neck, and in serum type 1 collagen C‑telopeptide (sCTX) and procollagen type 1 N-telopeptide (P1NP) at 12 and 24 months. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
Of the 300 patients included in the study, 143 received denosumab and 157 received risedronate.
A significant mean difference (95% CI) in percent change from baseline in BMD was observed between the 2 groups at lumbar spine, total hip, and femoral neck at month 12 (1.8%, 1.9%, and 1.5%, respectively) and month 24 (3.2%, 2.3%, and 2.1%, respectively). At month 24, the mean percent change from baseline in BMD was significant at lumbar spine, total hip, and femoral neck with denosumab, and only at lumbar spine with risedronate.
During the first 5 months, sCTX and P1NP levels were significantly reduced in patients who received denosumab vs risedronate, but no significant difference was observed in percent change from baseline between the 2 groups at 12 and 24 months.
The TEAEs, including infections and cardiac disorders, were similar between the denosumab and risedronate group (78.3% vs 75.8%, respectively).
Incidence of osteoporotic fractures was lower among patients in the denosumab vs risedronate group (6.3% vs 9.6%, respectively).
Researchers concluded, “Compared with [risedronate], treatment with [denosumab] showed significantly larger gains in BMD in patients with [glucocorticoid-induced osteoporosis] and RA receiving [glucocorticoid] treatment. The overall safety profile was similar for both treatments.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Adachi J, Chines A, Huang S, Saag K, Lems W, Geusens P. Safety and efficacy of denosumab vs risedronate in patients with glucocorticoid-induced osteoporosis and rheumatoid arthritis. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 0445.
This article originally appeared on Rheumatology Advisor