Author(s)
Hollis K1, Abuzakouk M2, Balp M3, Berard F4, Canonica GW5, Gimenez-Arnau A6, Grattan C7, Khalil S3, Knulst AC8, Lacour J9, Lynde C10, Maurer M11, McBride D12, Nakonechna A13, Ortiz de Frutoz FJ14, Oude Elberink J15, Proctor C1, Sussman G16, Sweeney C1, Tian H17, Weller K11, Marsland A18
1RTI Health Solutions, Research Triangle Park, NC, USA, 2Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates, 3Novartis Pharma AG, Basel, Switzerland, 4Claude Bernard University Lyon, Lyon, France, 5University of Genoa, Genoa, Italy, 6Hospital del Mar. Parc de Salut Mar, Barcelona, Spain, 7Guy's Hospital, London, UK, 8University Medical Center Utrecht, Utrecht, The Netherlands, 9Université Nice Sophia Antipolis, Nice Cedex 2, France, 10Lynderm Research Inc., Toronto, ON, Canada, 11Charite - Universitätsmedizin Berlin, Berlin, Germany, 12RTI Health Solutions, Manchester, UK, 13Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK, 14Hospital 12 Octubre, Madrid, Spain, 15University of Groningen, Groningen, The Netherlands, 16University of Toronto, Toronto, ON, Canada, 17Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 18Salford Royal Hospital and University of Manchester, Salford, UK
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.
