Abstract
SummaryPersistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium found that persistence with denosumab remains consistently high after 24 months in patients at high risk of fracture.PurposeContinued persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of clinical practice evaluated medication-taking behavior of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium and factors influencing persistence.MethodsSubcutaneous denosumab (60 mg every 6 months) was assigned according to prescribing information and local guidelines before and independently of enrollment; outcomes were recorded during routine practice for up to 24 months. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection and adherence as administration of subsequent injections within 6 months ± 4 weeks of the previous injection. Medication coverage ratio (MCR) was calculated as the proportion of time a patient was covered by denosumab. Associations between pre-specified baseline covariates and 24-month persistence were assessed using multivariable logistic regression.ResultsThe 24-month analyses included 1479 women (mean age 66.3–72.5 years) from 140 sites; persistence with denosumab was 75.1–86.0%, adherence 62.9–70.1%, and mean MCR 87.4–92.4%. No covariate had a significant effect on persistence across all four countries. For three countries, a recent fall decreased persistence; patients were generally older with chronic medical conditions. In some countries, other covariates (e.g., older age, comorbidity, immobility, and prescribing reasons) decreased persistence. Adverse drug reactions were reported in 2.3–6.9% patients.ConclusionsTwenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics. Further studies are needed to identify determinants of low persistence.
Highlights
With an aging population, the prevalence of osteoporosis in Europe is expected to rise by approximately a quarter between 2010 and 2025, resulting in a similar increase in the incidence of osteoporotic fracture [1, 2]
Twenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics
To be eligible to participate in the study, patients must have been suitable for treatment with, and to have been prescribed, SC denosumab 60 mg Q6M in accordance with the appropriate prescribing information (e.g., European Union (EU) Summary of Product Characteristics or the local equivalent) for the treatment of postmenopausal osteoporosis (PMO) and in accordance with national guidelines
Summary
The prevalence of osteoporosis in Europe is expected to rise by approximately a quarter between 2010 and 2025, resulting in a similar increase in the incidence of osteoporotic (fragility) fracture [1, 2]. In 2010, there were 3.5 million new fragility fractures among women in the European Union (EU) [3]. Such fractures are a major cause of morbidity owing to the pain and immobility with which they are associated. They increase mortality, with hip fractures being associated with half of the deaths attributable to osteoporosis [2]. The majority of hip fractures result in hospitalization, which is often lengthy, and costs associated with osteoporosis are expected to reach €46.8 billion by 2025 [2]
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