INTRODUCTION: The current analysis used data from the ASSURE-CSU study to assess the economic and humanistic burden associated with angioedema in patients with chronic spontaneous/idiopathic urticaria (CSU/CIU).
METHODS: The ASSURE-CSU study, conducted in 7 countries (Canada, France, Germany, Italy, Spain, Netherlands and the United Kingdom), enrolled patients with CSU aged ≥18 years with disease persisting for ≥12 months and symptomatic despite current treatment. Physicians reported angioedema from medical charts and patients reported angioedema via a survey and a 7-day diary. Angioedema was defined as: YES-ANGIO when both physicians and patients reported angioedema, NO-ANGIO when neither reported angioedema, and Misaligned, where only one source recorded angioedema. Patients completed Dermatological Life Quality Index (DLQI) and Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire at recruitment, Urticaria Activity Score over 7 days (UAS7) afterwards and Work Productivity and Activity Impairment- Specific Health Problem (WPAI-SHP) questionnaire in the 8th day from enrolment. All outcomes were evaluated for the 3 angioedema groups; significance tests were performed between YES-ANGIO and NO-ANGIO patients.
RESULTS: Among 643 patients with complete angioedema data, there were 259 (40.3%) cases in YES-ANGIO, 173 (26.9%) in NO-ANGIO, and 211 (32.8%) cases in Misaligned groups. The majority of Misaligned cases were based on patients reporting angioedema but not the physicians. YES-ANGIO patients reported significantly higher mean [SD] DLQI and CU-Q2oL scores vs NO-ANGIO patients (10.4 [6.85] vs 6.6 [5.21]) & 37.6 [20.81] vs 23.4 [17.12]) respectively (both p<.0001). Mean [SD] UAS7 score was significantly higher in YES-ANGIO compared to NO-ANGIO patients (17.6 [10.55] vs 14.6 [8.97], p=0.0032). YES-ANGIO patients experienced significantly greater mean % [SD] absenteeism (9.1 [23.22] vs 1.4 [9.08]), overall work impairment (29.2 [28.48] vs 19.1 [21.37]) and overall activity impairment (34.5 [29.68] vs 23.8 [23.92]) than the NO-ANGIO group (all p<.05), respectively. Outcomes in Misaligned patients followed the same pattern as YES-ANGIO patients.
CONCLUSIONS: Angioedema patients experienced substantially higher economic and humanistic burden compared to those without angioedema. Patients with misaligned angioedema reported similar burden to patients with angioedema. Overall, angioedema is associated with incremental humanistic and economic burden in CSU and appears to be under-reported in medical charts.
