Abstract
Summary
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.
Introduction
The purpose of this study was to describe the characteristics of patients who initiated denosumab and estimate persistence with therapy.
Methods
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.
Results
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%).
Conclusions
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.
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Acknowledgements
We thank IMS Brogan Inc. for use of their Drug Information Database. This work was completed as part of Joann K. Ban’s M.Sc. thesis at the University of Toronto. Analyses were completed by Joann K. Ban at ICES University of Toronto, with support from the Leslie Dan Faculty of Pharmacy. Joann K. Ban held a training award stipend from the Canadian Institutes of Health Research Drug Safety and Effectiveness Cross-Disciplinary Training (DSECT) Program. Authors thank John-Michael Gamble for insightful discussions and M. Amine Amiche and Giulia P. Consiglio for analytical support.
Funding
This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources. No endorsement by ICES or the Ontario MOHLTC is intended or should be inferred. Parts of this material are based on data and/or information compiled and provided by the Canadian Institutes of Health Information (CIHI). However, the analyses, conclusions, opinions, and statements expressed in the material are those of the authors and not necessarily those of CIHI.
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Ban, J., Hao, B., McCarthy, L. et al. Denosumab utilization among older adults in Ontario: patient characteristics, persistence with therapy, and return to therapy after an extended gap. Osteoporos Int 30, 1865–1872 (2019). https://doi.org/10.1007/s00198-019-05051-1
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DOI: https://doi.org/10.1007/s00198-019-05051-1