AB0682 DISEASE BURDEN AND UNMET NEED IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS TREATED WITH ADVANCED THERAPY: RESULTS FROM A REAL-WORLD SURVEY IN EUROPE AND THE UNITED STATES

Abstract

Background Unmet medical need continues to be significant in patients with systemic lupus erythematosus (SLE) despite the use of advanced therapies (AT) to control active disease. Fatigue, end-organ damage, and low health-related quality of life (HRQOL) remain characteristic of the disease even among those treated with AT. Objectives In this analysis we measured the burden of unmet medical need in SLE patients prescribed AT for ≥12 months in real-world clinical settings. Methods Data were drawn from the Adelphi Real World Lupus Disease Specific Programme™, a cross-sectional survey with elements of retrospective data collection of rheumatologists and their consulting patients with SLE in France, Germany, Italy, Spain, the United Kingdom, and the United States in 2021. Rheumatologists provided information on patient demographics, clinical status, and treatment history for their next six consulting SLE patients. The same patients completed the EQ-5D-5L, Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue), and Work Productivity and Activity Impairment questionnaire (WPAI) instruments. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores were derived through physician assessment of patients’ current clinical manifestations. AT was defined as biologics or off-label Janus kinase inhibitors. All data were analysed descriptively. Results The sample included 234 patients seen by 125 physicians. Most patients (85%) were female and the mean participant age was 45.8 (SD:13.2) years. Mean duration since diagnosis was 6.6 (5.3) years and mean duration on their current regimen was 3.3 (3.0) years. Despite receiving AT for ≥12 months, patients continued to have moderate-high levels of disease activity. Nearly half (48%) had SLEDAI scores ≥ 10 (Mean SLEDAI = 11.4 (11.2)). Many (37%) were assessed by physicians to have moderate/severe disease. Most (62%) continued to receive steroids, with 41% of patients prescribed oral/subcutaneous steroids receiving prednisone or equivalent doses of ≥7.5 mg/day. The majority of patients (56%) were ‘currently experiencing’ musculoskeletal symptoms including joint tenderness and swelling; while 37% and 19% respectively, were currently experiencing mucocutaneous and renal symptoms. Mean EQ5D-5L score was 0.70 (0.27). Mean FACIT-Fatigue score was 32.4 (12.4), compared to US general population norm of 43.6 (9.4)1. Overall work impairment and mean daily activity impairment measured by the WPAI were 27.4% (20.4%) and 34.9% (25.3%) respectively. Conclusion Unmet medical need in SLE patients remained high despite long term use of AT. Study results suggest the need for more efficacious treatment options that reduce disease activity, reduce reliance on high-dose steroids, and improve quality of life.