ASSURE-CSU: RESOURCE USE AND ECONOMIC BURDEN IN PATIENTS WITH REFRACTORY CHRONIC SPONTANEOUS URTICARIA IN ITALY PHS58 Alessandro Roccia , Laura Rigoni , Matt Cawson , Doreen McBride , Giorgio Walter Canonica , 4 Maria-Magdalena Balp 1 1 2 2 3 Novartis Farma, Italy; 2RTI Health Solutions, Manchester, UK; 3Respiratory Disease & Allergy Clinic, DIMI, Genoa University, Italy; 4 Novartis Pharma AG, Basel, Switzerland 1 INTRODUCTION spontaneous urticaria (CSU) is defined as the spontaneous development of itchy hives and/or • Chronic angioedema that reoccurs for ≥6 weeks due to known or unknown causes . any given time, CSU is believed to affect 0.5%-1 % of the global population and it remains • At uncontrolled in approximately 50% of patients, despite the use of licensed, recommended doses of 1 2 • • modern, second-generation H1-antihistamines1. In addition to the physical manifestations, CSU can have a profound impact on the lives of patients due to factors such as sleep disruption, anxiety, embarrassment, depression, social isolation as well as impaired work performance or absence from work for patients who are employed3. The full impact of inadequately controlled CSU was not fully assessed and few data published. Total direct medical costs from the medical record—including inpatient, emergency room and emergency physician visits, routine physician visits, laboratory tests, and therapies recorded in the medical record—were calculated to be a mean (median, [SD]) of 679.10 € (116.60, [1820.02]) annually. Overall, the main cost drivers were therapy costs with an annual mean (median, [SD]) of 440.90 € (40.00, [1,094.53]), inpatient costs with an annual mean (median, [SD]) of 145.10 € (0.00 [886.91]) and emergency visit costs with an annual mean (median, [SD]) of 68.9 € (0.00 [147.19]). Figure 3 OBJECTIVES • The objective of ASSURE-CSU was to identify and quantify the humanistic, societal, and economic burden of the disease in patients with inadequately controlled CSU, with a focus on patients in whom the disease persists for ≥12 months in 7 countries. Here we report the key study results on medical resource use and work impairment of the CSU population in Italy. METHODS (ASsessment of the Economic and Humanistic Burden of Chronic Spontaneous/Idiopathic • ASSURE-CSU URticaria PatiEnts) was an observational, multinational, multicenter study conducted in UK, Germany, Canada, France, Italy, Spain, and The Netherlands. CSU patients who were aged ≥18 years, symptomatic despite current treatment, and having symptoms since at least 12 months were included. Among the 41% of employed patients (n = 29), mean % (SD) of presenteeism absenteeism and overall work impairment due to CSU/CIU in the past 7 days were 1.7% (4.39), 21.4% (20.50) and 22.4% (22.05), respectively (Figure 4). Highest percentages were reported by patients with severe urticaria activity, followed by patients with moderate activity. Figure 4 Figure 5 study included a 12-month retrospective medical chart review, a cross-sectional patient survey • The and a 7-day prospective patient diary (UPDD), containing the twice-daily Urticaria Activity Score (UAS). A UAS score over 7 days (UAS7), ranging from 0 (no urticaria) to 42 (highest activity) was calculated4. Patients completed the Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) on the 8th day. WPAI is measured by 6 questions covering 4 domains: absenteeism (work time missed), presenteeism (impairment at work), overall work impairment and activity impairment; higher scores reflecting greater absence & impairment and reduced productivity. Indirect costs were calculated based on the WPAI-SHP answers and extrapolated to a 4-week period using a national average 4-week salary obtained from Bank of Italy reports and national statistics6,7. Direct costs were calculated in Euros using published national sources8,9. Data were analysed using descriptive statistics stratified by disease activity ranges (UAS7TD). RESULTS In Italy a total of 8 sites enrolled 75 patients; 64% were female and 41% employed; mean (SD) age at onset, diagnosis and enrollment were 48.7 (16.57) , 49.0 (15.91), 52.7 (16.22) years, respectively. Overall, 48% of patients had ≥1 CSU-related visits to a healthcare professional (HCP) in the past 12 months (mean [SD]: 2.9 [2.15]), and 24% of patients ≥1 emergency room (ER) visits (mean [SD]:1.3 [0.57]). (Figure 1 and 2). Figure 1 Health care professional visits (HCP) in past 12 months Total indirect costs of overall work impairment over 4 weeks (Figure 5) were calculated to be a mean (median [SD]) of 459.60 € (411.10 [453.26]). These costs were driven by presenteeism in patients with moderate and severe CSU. CONCLUSION Patients with uncontrolled CSU have a high use of medical resources and report absence from work and reduced productivity which increased with increased activity, resulting in a high societal economic burden. Currently approved treatments (H1-antihistamines) for patients with CIU often have limited efficacy, which indicates a clinical need for more efficacious therapies in the refractory states. This is the first study to estimate the economic burden of CSU of patients in Italy still symptomatic despite treatment. This research provides real-world evidence of the substantial economic burden of CSU to patients and society, with activity and work impairment, as well as high health care resource use. LIMITATIONS Sample sizes were relatively small (n = 75 overall), especially for the stratified disease severity states, thus limiting interpretation of results. A pooled analysis of all countries data was conducted and data presented elsewhere. ABBREVIATIONS AND REFERENCES Figure 2 Hospitalisation and ER visits in past 12 months AE-QoL= Angioedema Quality of Life; CU-Q2oL= Chronic Urticaria Quality of Life Questionnaire; DLQI= Dermatology Life Quality Index; EQ-5D= EuroQol 5 Dimensions; UAS7= Urticaria Activity Score over 7 days; UPDD= Urticaria Patient Daily Diary; WPAI-SHP= Work Productivity and Activity Impairment- Specific Health Problem. 1. 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