Clinical and Cost Burden of Primary Sjögren’s Syndrome: Descriptive Analysis Using a US Administrative Claims Database

Abstract

**Background:** Current knowledge of the disease burden of primary Sjögren’s syndrome (pSS) is limited. **Objectives:** The primary objective of this study was to describe the demographic and clinical characteristics of patients with pSS. The secondary objective was to describe the treatment patterns and healthcare resource utilization of patients with pSS. Furthermore, clinical characteristics of interest were described and the proportions of patients with glandular versus extra-glandular disease were reported. **Methods:** This was a retrospective cohort study (HO-15-16077) conducted in the US Truven MarketScan Commercial database. We report descriptive data from employees and their families, as covered by employer-sponsored medical insurance. The primary cohort comprised patients with pSS (with ≥1 diagnosis of sicca syndrome prior to January 1, 2013), with continuous enrollment for ≥24 months (January 1, 2012–December 31, 2013). Patients with conditions mimicking sicca symptoms not due to SS were excluded, as were those with connective tissue disease that may have suggested secondary SS. To compare the healthcare burden of patients with and without sicca symptoms, a 1:1 matched comparator population comprising subjects without a previous diagnosis of sicca syndrome (sicca-free) was also identified. **Results:** There were 12 717 eligible patients in the primary cohort. The majority (86%) was female and the mean age was 51 years. Overall, 60.7% of patients had claims associated with pSS extra glandular disease manifestations. These patients experienced a higher disease burden, and more commonly reported pain, fatigue or insomnia and any combination of pain, fatigue or insomnia (41.3%) compared with patients with glandular disease only (12.4%). Patients in the primary cohort incurred greater annual healthcare service costs (1.6 times greater, all causes) and healthcare resource utilization compared with the sicca-free comparator cohort. Patients with extra glandular disease also incurred greater average annual costs (2.9 times) contributing to ≥2 times/year more resource use for outpatient services than patients with glandular disease only. **Conclusion:** Patients with pSS experience a high disease burden despite treatment. This study provides novel insights in to the extent of the burden on healthcare resources among patients with pSS, in particular for patients with extra-glandular disease manifestations, when compared with sicca-free subjects.