Kobayashi Kazuyoshi, Ando Kei, Machino Masaaki, Morozumi Masayoshi, Kanbara Shunsuke, Ito Sadayuki, Inoue Taro, Yamaguchi Hidetoshi, Ishiguro Naoki, Imagama Shiro
Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Asian Spine J. 2020 Aug;14(4):453-458. doi: 10.31616/asj.2019.0230. Epub 2020 Jan 17.
Retrospective study in a single center.
To examine denosumab persistence in patients of different ages with severe osteoporosis in Japan.
Denosumab is an antibody drug used for the treatment of osteoporosis. It is mainly used in patients with severe osteoporosis who might have high motivation for treatment, and the need for only semi-annual subcutaneous injection might improve the continuation rate. However, no English-language articles have reported on denosumab persistence in the Japanese population, including young people, despite the importance of this issue in a super-aging society.
The subjects started treatment with subcutaneous denosumab in our department from July 2013 until December 2017. Persistence rates were calculated using Kaplan-Meier curves. Patients were defined as "persistent" or "non-persistent" according to the use of therapy after 60 months.
The study included 101 patients (84 females) with a median follow-up period of 23.6±14.2 months. The persistence rate declined to 85.3%, 78.3%, 74.1%, 71.3%, and 69.3% at 12, 24, 36, 48, and 60 months, respectively. Age at the initiation of denosumab therapy differed significantly between non-persistent (n=31) and persistent (n=70) patients (81.3 vs. 72.8 years, p <0.01). Persistence was significantly lower in patients aged ≥80 years than in those aged <60 and 60-79 years (both p <0.01). The reasons for non-persistence of denosumab therapy were transfer to another hospital (n=13), interruption of outpatient visits (n=11), dental treatment (n=4), adverse events (n=2), and patient request (n=1).
Persistence was significantly lower in patients aged ≥80 years than in patients of other ages, and strategies promoting persistence are needed for these elderly patients.
单中心回顾性研究。
研究日本不同年龄段重度骨质疏松患者使用地诺单抗的持续性。
地诺单抗是一种用于治疗骨质疏松症的抗体药物。它主要用于可能有较高治疗积极性的重度骨质疏松患者,且仅需每半年皮下注射一次,这可能会提高治疗的持续率。然而,尽管在超老龄化社会中这个问题很重要,但尚无英文文章报道包括年轻人在内的日本人群使用地诺单抗的持续性情况。
研究对象于2013年7月至2017年12月在我科开始接受皮下注射地诺单抗治疗。使用Kaplan-Meier曲线计算持续率。根据60个月后的治疗使用情况将患者定义为“持续用药”或“未持续用药”。
该研究纳入了101例患者(84例女性),中位随访期为23.6±14.2个月。在12、24、36、48和60个月时,持续率分别降至85.3%、78.3%、74.1%、71.3%和69.3%。未持续用药患者(n = 31)和持续用药患者(n = 70)开始使用地诺单抗治疗时的年龄差异显著(81.3岁对72.8岁,p <0.01)。≥80岁患者的持续率显著低于<60岁和60 - 79岁患者(均p <0.01)。地诺单抗治疗未持续用药的原因包括转至其他医院(n = 13)、门诊就诊中断(n = 11)、牙科治疗(n = 4)、不良事件(n = 2)和患者要求(n = 1)。
≥80岁患者的持续率显著低于其他年龄段患者,需要为这些老年患者制定提高持续率的策略。