Hollis K, Abuzakouk M, Balp M, Berard F, Canonica GW, Gimenez-Arnau A, Grattan C, Khalil S, Knulst AC, Lacour J, Lynde C, Maurer M, McBride D, Nakonechna A, Ortiz De Frutos J, Oude Elberink J, Proctor C, Sussman G, Sweeney C, Tian H, Weller K, Marsland A. Assessing health-utility values for chronic spontaneous/idiopathic urticaria in real-world using the EQ-5D: results from ASSURE-CSU study. Poster presented at the 2016 ISPOR 19th Annual European Congress; November 1, 2016. Vienna, Austria. [abstract] Value Health. 2016 Nov; 19(7):A570-1.

OBJECTIVES: Chronic spontaneous/idiopathic urticaria (CSU/CIU) can significantly impact patients’ lives when inadequately controlled. Real-world data on health status and utility values for CSU are unavailable. The present analysis reports EQ-5D health status from the ASSURE-CSU study.

METHODS: ASSURE-CSU is an observational study, which included a 1-year retrospective medical record abstraction, a cross-sectional patient-reported survey, and a 7-day prospective patient diary. Adult patients with symptomatic disease despite treatment were recruited in 7 countries (Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom). Patients completed twice-daily Urticaria Activity Score summed over 7 days (UAS7TD), used to define disease activity categories: score 0 (urticaria-free), 1-6 (well-controlled urticaria), 7-15 (mild), 16-27 (moderate), and 28-42 (severe). The EQ-5D-3L is a standardised, preference-based measure of health status comprised of five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), scored on a scale of 1 to 3 (no to extreme problems). A single index utility value was calculated ranging from 0 (death) to 1 (perfect health). Pooled country data were analysed using descriptive statistics and stratified by UAS7TD categories.

RESULTS: A total of 627 patients completed EQ-5D. The mean (SD) EQ-5D utility score estimate was 0.714 (0.2907). Mean (SD) utility decreased as UAS7TD disease activity increased: 0.826 (0.2147), 0.758 (0.2524), 0.674 (0.3077), and 0.601 (0.3423) for urticaria-free/well-controlled, mild, moderate, and severe urticaria respectively. Pain/discomfort and anxiety/depression were the most frequently affected domains, with patients reporting moderate (52.2% and 39.2%, respectively) and extreme (11.0% and 8.2%, respectively) problems. The percentage of patients reporting moderate or extreme problems was higher on all five domains among those with high activity.

CONCLUSIONS: Patients with increasing activity of CSU had a consistent decrease in utility scores, reflecting a lower QoL. Patients reported complaints related to pain/discomfort and anxiety/depression. Utility values reported in real-world are consistent with those recently published from omalizumab in CSU phase III trials.