Background Comprehensive analyses appraising the medical and economic burden of chronic, complex disorders such as SLE, and assessment of unmet therapeutic needs are most valuable for clinical and health policy decisions and funds allocation. Existing analyses in SLE are either out-dated or they have been derived from single centres.

Objectives To evaluate the clinical characteristics and annual direct medical cost for adult Greek patients with SLE, and quantify at a single-country level the prevalence of active severe SLE.

Methods Retrospective chart-based study of adult SLE patients (n=215) with active autoantibody-positive disease at a predefined ratio 30% severe and 70% non-severe disease, followed-up at seven mixed secondary/tertiary hospital centres in Greece spanning the entire country. Consecutive, unselected SLE patients registered at the participating centres over a 3-month period (n=381) were also evaluated. Disease characteristics, activity (SELENA-SLEDAI [SS]) and severity, organ damage (SLICC/ACR damage index [SDI], flares, and healthcare resource utilization were recorded. Costs were assessed from the third party payer perspective.

Results At entry visit, severe SLE patients (active involvement of major organs requiring treatment) were more likely to have chronic active disease (22.4% versus 4.7%), increased activity (mean SS: 10.5 versus 6.1) and damage (mean SDI: 1.1 versus 0.6) than non-severe patients. During one-year follow-up, severe SLE patients were more likely to experience ≥1 flare (82% versus 57%). The mean annual direct medical cost was 3-fold higher in severe compared to non-severe patients (€ 3,741 versus € 1,225), mostly due to increased medications and hospitalization costs. Severe flares, active renal disease, and organ damage at baseline were associated with 124%, 59% and 79% to 197% increased health cost, respectively. Among unselected patients, 19% had active severe SLE within the past 6 months (7.1% with active nephritis), and 30% of them had persistently active disease in spite of standard-of-care therapy.

Conclusions In this nation-wide study in Greece, approximately one out of five adult SLE patients followed at tertiary care centres has active severe disease, associated with significant clinical and financial burden. Among them, 30% have ongoing disease activity and may be candidates for novel therapies.

Acknowledgements The study was sponsored by GlaxoSmithKline (Number 116923). Data collection and analysis was performed by Health Data Specialists Ltd.

Disclosure of Interest G. Bertsias Speakers bureau: Honorary fees from GlaxoSmithKline and UCB, E. Karampli Grant/research support from: GlaxoSmithKline, Pfizer, Roche, P. Sidiropoulos: None declared, A. Drosos Speakers bureau: Honorary fees from GlaxoSmithKline and Bristol Myers Squib, L. Sakkas: None declared, A. Garyfallos Grant/research support from: GSK, UCB, A. Tzioufas Grant/research support from: Pfizer, GlaxoSmithKline, Roche, ABBVIE, UCB, MSD and Novartis, D. Vassilopoulos: None declared, P. Sfikakis: None declared, K. Athanasakis Grant/research support from: GlaxoSmithKline, Pfizer and Roche, A. Perna Employee of: GSK, D. Psomali Employee of: GSK, J. Kyriopoulos Grant/research support from: GlaxoSmithKline, Pfizer and Roche, D. Boumpas: None declared