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

Takeshi Mochizuki, Koichiro Yano, Katsunori Ikari, Ken Okazaki, Takeshi Mochizuki, Koichiro Yano, Katsunori Ikari, Ken Okazaki

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.

Keywords: Bone mineral density; Disease activity; Osteoporosis; Rheumatoid arthritis; Romosozumab.

Conflict of interest statement

Takeshi Mochizuki received honoraria for lectures from Astellas, Bristol-Myers, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Janssen, Mochida, Pfizer, and Tanabe-Mitsubishi. Koichiro Yano received honoraria for lectures from AbbVie, Astellas, Ayumi, Bristol-Meyers, Eisai, Hisamitsu, Mochida, and Takeda. Katsunori Ikari received honoraria for lectures from AbbVie, Astellas, Bristol-Myers, Chugai, Eisai, Eli Lilly, Janssen, Takeda, Tanabe-Mitsubishi, and UCB. Ken Okazaki has no conflicts of interest. The sponsors were not involved in the study design; collection, analysis, and interpretation of data; writing of the article; and/or decision to submit the results for publication.

© 2021 The Korean Society of Osteoporosis. Publishing services by Elsevier B.V.

Figures

Fig. 1
Fig. 1
The percent changes from the baseline in the bone mineral densities of the (a) lumbar spine, (b) total hip, and (c) femoral neck regions. Circle and solid line, romosozumab group; triangle and dotted line, denosumab group.
Fig. 2
Fig. 2
Changes in disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR). Circle and solid line, romosozumab group; triangle and dotted line, denosumab group.

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Source: PubMed

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