Background and Objectives: Chronic spontaneous/idiopathic urticaria (CSU/CIU) is a disease which impacts health-related quality of life (HRQoL). Data on the impact of the disease on HRQoL in patients refractory to standard of care are limited. ASSURE-CSU is an observational, multinational, multicenter study to identify and quantify the humanistic and economic burden of illness in refractory CIU/CIU patients.
Methods: This study consisted of a 1-year retrospective medical record abstraction, a cross-sectional patient-reported outcomes survey and an 8-day prospective patient diary. Patients completed the Dermatology Life Quality Index (DLQI; 0-30) and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL; 0-100) and the weekly Urticaria Activity Score (UAS7; 0-42). Pre-specified UAS7-based ranges categorised patients by disease severity.
Results: A total of 99 and 83 patients were recruited in Canada and the UK respectively. Demographics were similar in both countries. The mean age was 50.8 and 49.7 years, mean disease duration 62.0 and 57.3 months; 77.8% and 79.5% female; in Canada and UK respectively. Angioedema, in the previous 12 months was reported in 49.5% and 41% of patients respectively.
UAS7 was completed by 86 patients with an average overall score of 19. Based on UAS7 ranges, 11 (12.8%), 28 (32.5%), 23 (26.7%) and 22 (25.6%) patients were in well-controlled, mild, moderate and severe urticaria states respectively. Overall mean DLQI score was 9.9 (n=88) with work and school, symptoms and feelings, and daily activities being the dimensions most affected. DLQI score increased overall with disease severity (well-controlled: 7.5; mild: 6.9; moderate: 10 and severe urticaria: 15.5). Overall CU-Q2oL score was 41.4 and increased with disease severity (well-controlled: 34.9; mild: 31.2; moderate: 41.4 and severe urticaria: 59.6).
In the UK, UAS7 was completed by 74 patients, with a mean overall score of 20.3 and 6 (8.3%), 21 (29.2%), 28 (38.9%) and 17 (23.6%) patients in well-controlled, mild, moderate and severe urticaria states respectively. Overall the mean DLQI score was 10.6 (n=76) with symptoms and feelings, and daily activities being the dimensions most affected. DLQI score increased with severity of disease (well-controlled: 4.8; mild: 7.9; moderate: 12.5 and severe urticaria: 14.9). The overall CU-Q2oL score was 40.1 and also increased with severity of disease (well-controlled: 16.5; mild: 33.3; moderate: 47.9 and severe urticaria: 49.6).
Conclusions: This preliminary analysis suggests that CIU/CSU has significant impact on patient's lives; patients with more severe symptoms experienced greater HRQoL impairment.
