Effects of romosozumab or denosumab treatment on the bone mineral density and disease activity for 6 months in patients with rheumatoid arthritis with severe osteoporosis: An open-label, randomized, pilot study

Abstract

Objectives To investigate effects of romosozumab treatment on disease activity and bone mineral density (BMD) in patients with rheumatoid arthritis (RA) and severe osteoporosis in comparison with effects of denosumab treatment. Methods A total of 50 women were enrolled in this study. The subjects were randomized equally into 2 groups: the romosozumab group or the denosumab group. Disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR) and BMD at lumbar spine were evaluated. Results The percent changes (Δ) in the BMD values at 3 and 6 months for the lumbar spine were as follows: romosozumab; 4.9% and 5.2%, denosumab: 2.3% and 3.2%. The ΔBMD for the lumbar spine at 3 months was significantly higher in the romosozumab group than in the denosumab group (P = 0.044). The DAS28-ESR at baseline, 3 and 6 months in the romosozumab group were 2.88, 2.60 (P = 0.427) and 2.58 (P = 0.588), respectively. The change from baseline in DAS28-ESR did not differ significantly between these 2 groups at any time point. Conclusions The present study revealed that romosozumab treatment is more effective than denosumab treatment in increasing BMD of the lumbar spine at 3 months. Furthermore, the present study suggested that romosozumab treatment has no effects on the disease activity of RA in patients with RA and severe osteoporosis for 6 months.

Meta-analysis of the effects of denosumab and romosozumab on bone mineral density and turnover markers in patients with osteoporosis

“…This study identified 12 records from 158 studies in PubMed, of which six were removed through initial screening. The final six studies ( 18 – 23 ) met the selection criteria and were included in the meta-analysis. In a study conducted by Shimizu et al.…”

“…Outcomes are expressed as means or mean differences with 95% confidence intervals using random effects models. Heterogeneity was assessed using the I 2 test, in which I 2 values of 25%, 50%, and 75% were defined as low, moderate, and high, respectively (17). All analyses were performed using Review Manager (Revman) 5.4.…”

Clinical Studies On Romosozumab: An Alternative For Individuals With A High Risk Of Osteoporotic Fractures: A Current Concepts Review (Part II)

“…The study also suggested that ROMO treatment does not affect disease activity in patients with RA and severe osteoporosis at six months. 21 In another study, ROMO showed comparable effectiveness to DENO for increasing BMD in patients with RA treated with glucocorticoids. 22 Mochizuki et al investigated the effect of treatment with ROMO versus DENO on BMD in patients with RA.…”

The Inflammatory Contribution of B-Lymphocytes and Neutrophils in Progression to Osteoporosis

“…Gastroesophageal irritation can result in severe conditions such as esophageal ulcers or inflammation. In a study conducted with romosozumab and denosumab monoclonal antibody treatment for patients with rheumatoid arthritis accompanied by osteoporosis by Mochizuki et al (2021), the researchers observed side effects such as rash, joint pain, nausea, headache, hypertension, and itching in patients administered romosozumab and denosumab [89]. Abaloparatide, the parathyroid hormone analog used in combination with bisphosphonate, can also exhibit side effects, such as constipation, loss of appetite, pain in the bone and joints, and weakness [90].…”