Department of Orthopedic Surgery, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Primary Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Mod Rheumatol. 2022 Feb 28;32(2):284-291. doi: 10.1093/mr/roab022.
This study investigated changes in bone mineral density (BMD) and erosion after denosumab discontinuation in rheumatoid arthritis (RA) patients without osteoporosis who participated in the DESIRABLE study.
This multicentre observational study consisted of a prediscontinuation visit (date of final assessment in DESIRABLE) and a postdiscontinuation visit (2.5 years after the last administered dose of denosumab). Percentage change in lumbar spine (LS) BMD from baseline was assessed as the primary endpoint.
Fifty-nine patients were enrolled. The percentage change in LS BMD decreased to baseline levels at the postdiscontinuation visit. Compared with baseline, C-telopeptide of type I collagen levels increased after denosumab discontinuation but most patients had levels within the reference range. Bone erosion scores were not significantly different between the on-treatment period and after denosumab discontinuation (p = .0666) but there was a numerical increase postdiscontinuation. The progression in bone erosion score was significantly reduced in patients whose disease activity was in remission versus those not in remission (p = .0195).
In RA patients without osteoporosis, denosumab discontinuation can be explored while considering patient background factors (disease activity and risk of fracture) and accounting for progression of bone erosion and LS BMD decrease after withdrawal.
本研究旨在探讨未发生骨质疏松的类风湿关节炎（RA）患者停用地舒单抗后骨密度（BMD）和侵蚀的变化，这些患者曾参与 DESIRABLE 研究。
本多中心观察性研究包括停药前访视（DESIRABLE 研究中最后一次评估的日期）和停药后访视（末次地舒单抗给药后 2.5 年）。以腰椎（LS）BMD 从基线的百分比变化作为主要终点。
共纳入 59 例患者。LS BMD 的百分比变化在停药后访视时降至基线水平。与基线相比，地舒单抗停药后Ⅰ型胶原 C 端肽水平增加，但大多数患者的水平仍在参考范围内。骨侵蚀评分在治疗期间与停药后无显著差异（p=0.0666），但停药后有数值增加。与未缓解的患者相比，缓解的患者的骨侵蚀评分进展明显减少（p=0.0195）。
在无骨质疏松的 RA 患者中，在考虑患者的背景因素（疾病活动度和骨折风险）并考虑停药后骨侵蚀和 LS BMD 下降的进展的情况下，可以探索停用地舒单抗。
