Advances in Pharmacoepidemiology and Drug Safety

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Etanercept Patient Assistance Program: Another Data Source for Epidemiological Studies?

Brian C Chan, Soo Jin Seung, David McLean, Mary Bell, Neil H Shear and Nicole Mittmann

Background: Patient assistance programs (PAP) have been established for biologic disease modifying therapies such as etanercept to improve patient knowledge and compliance and provide a means for follow-up. The information collected through these programs is a potential data source to determine patient characteristics, patient outcomes, treatment adherence and reimbursement practices of individuals prescribed biologic disease modifying therapies.

Objective: To describe the population enrolled in the Enliven® Services Patient Assistance Program and to determine one-year retention rates.

Methods: A retrospective review of a Canadian cohort of patients enrolled in an etanercept PAP diagnosed with rheumatoid arthritis (RA) was conducted. Demographic and utilization information was collected for all subjects enrolled in the period between 2000 and 2007. One-year retention rates were also calculated from the data collected. Descriptive statistics were used to characterize the data.

Results: 14,335 subjects prescribed etanercept were enrolled in Enliven®. Average age at time of enrollment was 53 years. Three-quarters of subjects were female and four-fifths were English speaking. The largest percentage

Conclusion: The analysis provides a snapshot of individuals administered etanercept therapy over a 7-year timeframe. PAPs are a valuable source of data for research on biological therapies in addition to the support provided to the patients.