TY - JOUR
T1 - Factors associated with high 24-month persistence with denosumab
T2 - results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium
AU - Fahrleitner-Pammer, A.
AU - Papaioannou, N.
AU - Gielen, E.
AU - Tepie, M. Feudjo
AU - Toffis, C.
AU - Frieling, I.
AU - Geusens, P.
AU - Makras, P.
AU - Boschitsch, E.
AU - Callens, J.
AU - Anastasilakis, A. D.
AU - Niedhart, C.
AU - Resch, H.
AU - Kalouche-Khalil, L.
AU - Hadji, P.
PY - 2017/6/22
Y1 - 2017/6/22
N2 - Persistence 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.Purpose Continued 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.Methods Subcutaneous 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.Results The 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.Conclusions Twenty-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.
AB - Persistence 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.Purpose Continued 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.Methods Subcutaneous 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.Results The 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.Conclusions Twenty-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.
KW - Adherence
KW - Compliance
KW - Denosumab
KW - Non-interventional study
KW - Osteoporosis
KW - Persistence
KW - LONG-TERM PERSISTENCE
KW - RANDOMIZED-OPEN-LABEL
KW - ORAL BISPHOSPHONATES
KW - BONE TURNOVER
KW - MEDICATION ADHERENCE
KW - ALENDRONATE THERAPY
KW - UNITED-STATES
KW - FRACTURES
KW - EFFICACY
KW - SAFETY
U2 - 10.1007/s11657-017-0351-2
DO - 10.1007/s11657-017-0351-2
M3 - Article
C2 - 28643265
SN - 1862-3522
VL - 12
JO - Archives of Osteoporosis
JF - Archives of Osteoporosis
IS - 1
M1 - 58
ER -