Persistence with denosumab therapy among osteoporotic women in the Canadian patient-support program

Abstract

Objective:

The objective of this study was to evaluate persistence with denosumab among postmenopausal women with osteoporosis participating in the Canadian patient-support program (ProVital). Denosumab is an injectable therapeutic option for osteoporosis that is administered subcutaneously every 6 months.

Methods:

ProVital, a support program in which patients voluntarily enroll, provides next injection reminder calls and educational material. A retrospective database analysis of patient self-reported data was conducted among osteoporotic women aged ≥50 who enrolled in the ProVital program and received their first denosumab injection between August 2010 and June 2011. To achieve 12 month persistence patients had to receive at least two denosumab injections, and to achieve 24 month persistence patients had to receive at least four denosumab injections, with consecutive injections no more than 6 months + 8 weeks apart. Logistic regression analysis was used to identify predictors of persistence.

Results:

A total of 1676 patients (mean age 74 years) were included. The 12 month persistence with denosumab was 81.6% (1367/1676 patients), and the 24 month persistence was 59.1% (991/1676 patients). Characteristics associated with both 12 and 24 month persistence were possession of private medication insurance and residence in Quebec. Additionally, age greater than 75, previous postmenopausal osteoporosis medication use, and fracture were associated with 24 month persistence.

Limitations:

Patient enrollment in the program was voluntary, so there may be selection bias for the patient population included in this study. Also, this study did not have a control group of patients who were not enrolled in a patient support program.

Conclusions:

The persistence with denosumab among patients enrolled in the program was higher than historical persistence with oral bisphosphonates, and similar to persistence of patients in an education program taking teriparatide, patients taking bisphosphonates in a pharmaceutical care program, and two observational studies of denosumab.

Keywords: :

• Database
• Denosumab
• Osteoporosis
• Persistence
• ProVital

Transparency

Declaration of funding

This study was sponsored by Amgen Canada Inc.

Declaration of financial/other relationships

M.A. has disclosed that he is an employee of and shareholder in Amgen. M.E. has disclosed that she is a former Amgen employee. V.W. and L.B. have disclosed that they are employees of Optum contracted by Amgen. A.P., A.K., W.B., D.K., and J.D.A. have disclosed that they have received research funding from Amgen. A.P., A.B., A.K., W.B., D.K., J.D.A., and F.T. have disclosed that they were consultants to Amgen. A.P., W.B., J.D.A., D.K., and F.T. have disclosed that they were speakers for Amgen. D.K., A.B., A.K., and F.T. have disclosed that they were advisors to Amgen. A.P., A.K., and D.K. have disclosed that they received honoraria from Amgen. A.P. has disclosed that she has received grants/research support from Eli Lilly and Merck; speakers bureau/honoraria from Eli Lilly and Merck; and consulting fees from Eli Lilly and Merck. J.D.A. has disclosed that he has been a consultant/speaker for Actavis, Eli Lilly, Merck, and Novartis; and conducted clinical trials for Eli Lilly, Merck, and Novartis.

CMRO peer reviewer 1 has disclosed that he is a recipient of consulting and advisory board fees from Servier, Novartis, Negma, Eli Lilly, Amgen, GlaxoSmithKline, Roche, Merck, Nycomed, NPS, Theramex and UCB. Peer reviewers 2 and 3 have no relevant financial or other relationships to disclose.

Acknowledgments

Jesse Potash (Optum) provided medical writing assistance. The authors would like to thank Yvette Greiner, Michele Kohli, and Fang Liu from Optum, and Jennifer Lothian, Erin Mackinnon, Louisa Pericleous, and Melanie Poulin-Costello from Amgen, who were involved in the study at various stages. The authors would also like to thank John Leombruno from McKesson Specialty, the company that implemented the ProVital program, for his assistance during the study.

Notes

*ProVital® is a registered trademark of Amgen Inc., used with permission.

*ProVital® is a registered trademark of Amgen Inc., used with permission.