Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada.
Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada.
Osteoporos Int. 2019 Sep;30(9):1865-1872. doi: 10.1007/s00198-019-05051-1. Epub 2019 Jul 17.
We studied 46,797 older adults who initiated denosumab in Ontario, Canada. Patient characteristics remained relatively stable over time and aligned with public reimbursement restrictions. Almost half of patients persisted with therapy for at least 3 years. Fifty-nine percent of patients who discontinued denosumab returned to treatment within 3.6 years.
The purpose of this study was to describe the characteristics of patients who initiated denosumab and estimate persistence with therapy.
We identified older adults (aged ≥ 66 years) in Ontario who initiated denosumab between 2012/02 and 2015/03 and followed them to 2016/03. Patient characteristics were summarized using medical and pharmacy claims in the year before starting denosumab and osteoporosis drug use considered since 1996/10. Persistence with denosumab and return after discontinuation (> 90-day gap) were estimated using Kaplan-Meier curves. Analyses were stratified by community and long-term care (LTC) residence.
We identified 46,797 patients (monthly mean = 1263, SD = 187); 97% female, 13% LTC. Community-dwelling patients had a higher prevalence of bone mineral density testing (62% vs. 5%), yet were younger (mean age 78.5 vs. 86.6 years) and had lower prevalence of hip fractures (3% vs. 10%) compared to LTC patients. Eighty-two percent of patients had used osteoporosis medications in the past; 99% of whom took an oral bisphosphonate. Persistence was similar between community-dwelling and LTC patients: 59% persisted ≥ 2 years, 48% ≥ 3 years, and 38% ≥ 4 years, yet a larger proportion of LTC patients returned to denosumab after discontinuation (76% vs. 57%).
Denosumab utilization is increasing at a steady rate in Ontario. However, persistence remains a concern given the highly reversible pharmacokinetic profile of denosumab that results in a rapid increased fracture risk following discontinuation. Over 80% of patients had a history of oral bisphosphonate therapy, which may persist in bone despite discontinuing denosumab. Consequently, better understanding of denosumab safety and effectiveness among real-world users is important.
我们研究了在加拿大安大略省开始使用地舒单抗的 46797 名老年人。患者特征在一段时间内相对稳定，与公共报销限制一致。几乎一半的患者至少坚持了 3 年的治疗。59%停止使用地舒单抗的患者在 3.6 年内又回到了治疗中。
本研究的目的是描述开始使用地舒单抗的患者的特征，并估计其治疗的持久性。
我们在安大略省确定了 2012 年 2 月至 2015 年 3 月期间开始使用地舒单抗的年龄在 66 岁及以上的老年人，并对他们进行了随访至 2016 年 3 月。使用开始使用地舒单抗前一年的医疗和药房索赔，以及自 1996 年 10 月以来的骨质疏松症药物使用情况，对患者特征进行了总结。使用 Kaplan-Meier 曲线估计地舒单抗的持久性和停药后（间隔 >90 天）的恢复情况。分析按社区和长期护理（LTC）居住情况进行分层。
我们确定了 46797 名患者（月平均 1263 人，标准差 187）；97%为女性，13%为 LTC 患者。居住在社区的患者骨密度检测的患病率更高（62%比 5%），但年龄更小（平均年龄 78.5 岁比 86.6 岁），髋部骨折的患病率更低（3%比 10%）。82%的患者过去曾使用过骨质疏松症药物；其中 99%的人服用过口服双磷酸盐。居住在社区的患者和 LTC 患者的持久性相似：59%的患者持续治疗 2 年以上，48%的患者持续治疗 3 年以上，38%的患者持续治疗 4 年以上，但 LTC 患者停药后返回地舒单抗治疗的比例更大（76%比 57%）。
在安大略省，地舒单抗的使用正在以稳定的速度增长。然而，鉴于地舒单抗的药代动力学特征高度可逆，停药后骨折风险迅速增加，因此持久性仍然是一个问题。超过 80%的患者有口服双磷酸盐治疗史，尽管停止使用地舒单抗，这种药物仍可能在骨骼中持续存在。因此，了解真实世界使用者的地舒单抗安全性和有效性非常重要。
