Introduction: Chronic urticaria is a debilitating disease which impacts health-related quality of life (HRQoL) and increase costs to healthcare providers and society. Data is limited on the burden of patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) refractory to standard of care. ASSURE-CSU is an observational, non-interventional, multinational, multicenter study to identify and quantify the humanistic and economic burden of illness of refractory CIU/CSU patients.
Objectives: To report Canadian sub-analysis on demographics and HRQoL data in refractory CIU/CSU patients.
Methods: The study included a retrospective patient medical record abstraction and a cross-sectional patient-reported outcomes survey. At enrolment, HRQoL was assessed with Dermatology Life Quality Index (DLQI; 0-30) and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL; 0-100). Patients also completed the weekly Urticaria Activity Score (UAS7; 0-42), a composite disease activity score comprised of pruritus intensity score (0-21) and number of hives score (0-21). Pre-specified cut-offs of the UAS7 were used to divide patients by disease severity (1-6: well-controlled; 7-15 mild, 16-27 moderate and 28-42: severe urticaria).
Results: There were 99 patients from 9 sites across Canada with a mean age = 50.8; mean disease duration = 5 years; women = 77.8% and 49.5% of patients with concomitant angioedema. At time of diagnosis 2%, 30% and 42% had mild, moderate or severe disease (physician assessment) respectively. At enrolment, the UAS7 was completed by 86 patients with an average overall weekly score of 19 (hives score=10.1 and itch score = 8.9). Based on UAS7, 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. Data were incomplete for 2 patients. 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 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).
Conclusion: CIU/CSU has significant impact on patients’ lives; patients with more severe symptoms experienced greater HRQoL impairment. Consistent results were seen between DLQI and CU-Q2oL.
