Treatment Patterns and Health Care Costs for Patients With Psoriatic Arthritis on Biologic Therapy: A Retrospective Cohort Study
Introduction
Psoriatic arthritis (PsA) is an autoimmune disorder affecting the skin and joints. The disease may be chronic and disabling, and patients may experience osteolysis with destruction of the joint cartilages and bony surfaces, leading to deformity.1 In ~85% of patients, psoriasis generally begins before joint problems develop, and the onset of PsA usually occurs between 30 and 50 years of age.1 The estimated prevalence of PsA in the United States is 0.25% based on a survey of 27,200 adults.2 Medical comorbidities such as hypertension, cardiovascular disease, obesity, depression/anxiety, and infections are relatively common in psoriasis and PsA.3, 4 Furthermore, relative to psoriasis alone, PsA patients are more likely to experience hypertension, infections, neurologic conditions, gastrointestinal disorders, and liver disease.5 Both psoriasis and PsA have been associated with decrements in quality of life (QoL), but patients with PsA have poorer QoL outcomes than do those with psoriasis alone.6 The cost of illness and out-of-pocket expenses for psoriasis and PsA can be substantial,7, 8, 9 with total direct and indirect costs of these illnesses in the United States estimated at US $11 billion.7, 10
Mild to moderate cases of PsA have historically been treated with NSAIDs, conventional disease-modifying antirheumatic drugs (DMARDs), or intra-articular corticosteroid injections.11, 12 Although the evidence base is not well established, the efficacy and safety profiles of NSAIDs and the conventional DMARDs appear acceptable, and these treatments may offer symptom relief.12, 13 The use of conventional DMARDs as therapy concurrent with anti–tumor necrosis factor (TNF) is common in rheumatoid arthritis. However, the efficacy of this association is less clear in PsA.14 Guidelines published by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) indicate that some conventional DMARDs may be useful in treating peripheral arthritis and nail and skin disease in PsA.15 However, neither NSAIDs nor traditional DMARDs have been shown to slow radiographic progression of PsA.12 Newer biologic medications have been introduced that address the unmet medical needs of those patients with moderate to severe PsA or who have had an inadequate response or adverse reactions to conventional DMARDs. The high drug costs of biologic treatment may be offset by decreases in indirect costs coupled with improved health utility.16 The treatment patterns and health care costs of PsA patients treated with biologics as monotherapy or in combination with conventional DMARDs are unknown.
The purpose of this study was to examine medication use and health care costs in a sample of PsA patients initiating treatment with a biologic medication, either as monotherapy or adjunctively with a conventional DMARD. Longitudinal analyses investigated differences between the 2 cohorts regarding time to discontinuation of the index biologic treatment. Across the cohorts, concurrent medication use in both the pre- and post-index periods was identified, and health care costs over the post period were estimated and statistically evaluated.
Section snippets
Data Source
Data for this study were obtained from the Truven Health Analytics MarketScan® databases covering the January 1, 2005, to December 31, 2009, time period. These de-identified and Health Insurance Privacy and Portability Act–compliant data sources capture person-specific clinical utilization, biologic medication use, expenditures, and enrollment information across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and
Results
In the 3164 PsA patients in this study, the mean age was 49.4 years (Table II), with 53.4% being female (51.8% in the biologic monotherapy group vs 56.8% in the biologic + conventional DMARD group; P = 0.0089). The 2 cohorts were generally comparable regarding age, insurance type, medical payments, and comorbidities. Higher rates of comorbid psoriasis were observed in the biologic monotherapy group compared with the biologic + DMARD group (46.6% vs 40.5%; P = 0.0014), whereas higher rates of
Discussion
PsA patients in the current study had a complex comorbid profile; the diagnostic categories of rheumatoid arthritis, psoriasis, hyperlipidemia/dyslipidemia, hypertension, diabetes, chronic obstructive pulmonary disorder, chronic lower back pain, and infectious and parasitic disease were each present in over 10% of the study population. Consistent with this complex comorbid profile, the PsA patients in this study had high concurrent medication use, especially conventional DMARDs, pain
Conclusions
In this study, conventional DMARDs, when used adjunctively with biologic agents, reduced the rate of discontinuation but added pharmacy costs while not affecting overall medical expenditures in patients with psoriatic arthritis. Biologic therapies offer new approaches to patients who have an inadequate response to initial therapies or experience adverse reactions. Given the costs associated with biologics and developing knowledge of their safety profiles, it is important to evaluate these new
Conflicts of Interest
This study and analysis was funded by Eli Lilly and Company. Drs. Zhu, Ms. Edson-Heredia, and Dr. Shuler are employees and stockholders of Eli Lilly and Company. Dr. Gatz is an employee of Regenstrief Institute but was employed by Eli Lilly and Company at the time of the study. J. Guo is an employee of inVentiv Health Clinical under contract with Eli Lilly and Company. The authors have indicated that there are no other conflicts of interest regarding the content of this article.
ACKNOWLEDGMENTS
Dr. Zhu, Mrs. Edson-Heredia, and Ms. Guo had full access to the study data and take responsibility for the data’s integrity and analysis. Mrs. Edson-Heredia, Ms. Gatz and Dr. Zhu were responsible for the study concept and design. Mrs. Edson-Heredia, Dr. Zhu, Ms. Guo, Dr. Gatz, and Dr. Shuler were responsible for the analysis and interpretation of data. Mrs. Edson-Heredia, Dr. Zhu, Ms. Guo, Dr. Gatz, and Dr. Shuler were responsible for the critical revision of the manuscript for important
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