Persistence, adherence, and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany, Austria, Greece, and Belgium: 12-month results from a European non-interventional study

Abstract

SummaryPersistence with and adherence to osteoporosis therapy are critical for fracture reduction. This non-interventional study is evaluating medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in Germany, Austria, Greece, and Belgium. Patients were representative of the PMO population and highly persistent with and adherent to denosumab at 12 months.IntroductionPersistence with and adherence to osteoporosis therapy are important for optimal treatment efficacy, namely fracture reduction. This ongoing, non-interventional study will evaluate medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in routine practice in four European countries.MethodsThe study enrolled women who had been prescribed subcutaneous denosumab (60 mg every 6 months) in accordance with prescribing information and local guidelines. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection. Adherence was defined as receiving two consecutive injections within 6 months ± 4 weeks of each other. Medication coverage ratio (MCR) was calculated using the time a patient was covered with denosumab, as assessed from prescription records. Treatment was assigned prior to and independently of enrollment; outcomes are recorded during routine practice.ResultsThese planned 12-month interim analyses included data from 1500 patients from 141 sites. Mean age was 66.4–72.4 years, mean baseline total hip T-scores ranged from −2.0 to −2.1 and femoral neck T-scores from −2.2 to −2.6, and 30.7–62.1 % of patients had prior osteoporotic fracture. Persistence was 87.0–95.3 %, adherence 82.7–89.3 %, and MCR 91.3–95.4 %. In a univariate analysis, increased age, decreased mobility, and increased distance to the clinic were associated with significantly decreased persistence; parental history of hip fracture was associated with significantly increased persistence.ConclusionsThese data extend the real-world evidence regarding persistence with and adherence to denosumab, both of which are critical for favorable clinical outcomes, including fracture risk reduction.Electronic supplementary materialThe online version of this article (doi:10.1007/s00198-015-3164-4) contains supplementary material, which is available to authorized users.

Anti-Osteoporosis Medication Prescriptions and Incidence of Subsequent Fracture Among Primary Hip Fracture Patients in England and Wales: An Interrupted Time-Series Analysis

“…Further work is required given the wider availability of parenteral therapies with significantly greater adherence rates. (27) It is worth noting that in a post hoc analysis we found our decline in 3-year re-fracture rate to be occurring in the context of a stable 3-year mortality rate, although 1-year mortality did improve over the course of the study period (25.3% versus 19.8% for years 1999-2000 to 2012-13). However, given that fracture risk after hip fracture is high, improved survival at 1-year would likely increase rather than reduce the re-fracture rates as patients live longer at an elevated risk of re-fracture.…”

Three Years' Experience With the Biological Agent Denosumab Used to Treat Women With Postmenopausal Osteoporosis: Efficacy, Safety and Treatment Adherence

“…Следует обратить внимание на то, что четыре женщины с низким показателем FRAX ® , у которых в анамнезе не было переломов позвонков, а показатели МПК достигли уровня, соответствующего остеопении или норме, во всех областях измерения, перешли на прием только кальция и витамина D. Основной причиной отказа от терапии была стоимость ДС и невозможность получить его по льготному рецепту. Наши данные по привержен-ности в течение года соответствуют показателям настой-чивости пациентов в лечении этим препаратом, полу-ченным в четырех странах Европы (Германия, Австрия, Греция и Бельгия), которая составила 87-95,3% [13]. При этом настойчивость в лечении (как в нашей работе, так и в европейских странах) была в 1,5-10 раз выше, чем у больных, получавших бисфосфонаты (7,2-58%) [14,15].…”

“…А в европейском исследовании было выявлено достоверное влияние на приверженность нали-чия перелома бедра у родителей (в Австрии) и времени, которое затрачивалось на дорогу до клиники (в Бельгии). Наличие двух и более переломов у пациентов в анамнезе ассоциировалось с увеличением приверженности в Авст-рии и, в то же время, со снижением ее в Германии и Бель-гии [13].…”

Cancel the denosumab holiday

“…However, despite the favorable benefit risk profile, many-perhaps most-patients will discontinue therapy. In observational studies, persistence of 83-95 % after one year of denosumab therapy (meaning the patient received a second dose six months after their initial dose) and 68 % at 24 months has been described [17][18][19][20]. Data regarding longer-term treatment or outside a clinical trial setting are not yet available.…”