Kobayakawa Orthopedic and Rheumatologic Clinic, Shizuoka, Japan.
Department of Orthopaedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.
Mod Rheumatol. 2023 Jan 3;33(1):96-103. doi: 10.1093/mr/roac014.
Romosozumab is a newly released and widely known molecular-targeted drug for severe osteoporosis treatment with comparable effectiveness to denosumab. However, there have been no reports discussing the efficacy of those treatments for rheumatoid arthritis (RA) patients, especially those receiving glucocorticoids. This retrospective observational registry study compared the efficacy of 12-month treatment of denosumab and romosozumab in RA patients under the influence of glucocorticoid intake.
Following propensity score matching, 36 patients each in the denosumab and romosozumab groups were analysed in this study. Drug effectiveness was evaluated by measuring bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck at baseline, 6 and 12 months as well as alterations in P1NP, TRACP-5b, and simplified disease activity index (SDAI). The occurrence of adverse events and new fractures was also assessed.
At 12 months of treatment, BMD at the lumbar spine was increased by 7.5% in the denosumab group and 8.7% in the romosozumab group, which were both significantly and comparably elevated over baseline. At the total hip and femoral neck, romosozumab tended to exhibit favourable efficacy to increase BMD versus denosumab. Both P1NP and TRACP-5b were significantly lower in the denosumab group as compared with the baseline. Conversely in the romosozumab group, P1NP was increased over baseline, while TRACP-5b was decreased. Regarding SDAI alterations, both the romosozumab and denosumab groups exhibited comparable improvements in RA disease activity over time during treatment. Recorded adverse events and new fractures during treatment were few and minor in both groups.
Romosozumab exhibited comparable efficacy to denosumab for increasing BMD even under the influence of glucocorticoids for treating RA. Both drugs may be therefore suitable for managing osteoporosis in patients with RA and glucocorticoid intake.
罗莫佐单抗是一种新发布的、广为人知的治疗严重骨质疏松症的靶向分子药物，其疗效与地舒单抗相当。然而，目前尚无关于这些治疗方法对类风湿关节炎（RA）患者的疗效的报告，特别是对于接受糖皮质激素治疗的患者。本回顾性观察性注册研究比较了在接受糖皮质激素摄入影响下，地舒单抗和罗莫佐单抗治疗 RA 患者 12 个月的疗效。
通过倾向评分匹配，本研究分析了地舒单抗组和罗莫佐单抗组各 36 例患者。通过测量基线、6 个月和 12 个月时腰椎、全髋和股骨颈的骨密度（BMD）以及骨形成标志物 I 型前胶原氨基端延长肽（P1NP）、抗酒石酸酸性磷酸酶 5b（TRACP-5b）和简化疾病活动指数（SDAI）的变化来评估药物疗效。还评估了不良事件和新发骨折的发生情况。
治疗 12 个月时，地舒单抗组腰椎 BMD 增加了 7.5%，罗莫佐单抗组增加了 8.7%，与基线相比均显著升高且相当。在全髋和股骨颈，罗莫佐单抗组增加 BMD 的疗效倾向于优于地舒单抗组。与基线相比，地舒单抗组的 P1NP 和 TRACP-5b 均显著降低。相反，在罗莫佐单抗组，P1NP 较基线升高，而 TRACP-5b 则降低。关于 SDAI 变化，在治疗过程中，罗莫佐单抗组和地舒单抗组的 RA 疾病活动均随时间表现出相当的改善。在治疗过程中，两组均记录到的不良事件和新发骨折较少且较轻。
即使在接受糖皮质激素治疗 RA 的情况下，罗莫佐单抗增加 BMD 的疗效与地舒单抗相当。因此，这两种药物可能都适合管理接受糖皮质激素治疗的 RA 患者的骨质疏松症。
