BACKGROUND: ASSURE-CSU revealed differences in physician and patient reporting of angioedema. This post-hoc analysis was conducted to evaluate the actual rate of angioedema in the study population and explore differences between patients with and without angioedema.
METHODS: This international observational study assessed 673 patients with inadequately controlled chronic spontaneous urticaria (CSU). Physicians abstracted angioedema data from medical records, which were compared with patient-reported data. Patients in the Yes-angioedema category had angioedema reported in the medical record and a patient-reported source. For those in the No-angioedema category, angioedema was reported in neither the medical record nor a patient-reported source. Those in the Misaligned category had angioedema reported in only one source. Statistical comparisons between Yes-angioedema and No-angioedema categories were conducted for measures of CSU activity, health-related quality of life (HRQoL), productivity, and healthcare resource utilisation (HCRU). Regression analyses explored the relationship between Dermatology Life Quality Index (DLQI) score and angioedema, adjusting for important covariates.
RESULTS: Among evaluable patients, 259 (40.3%), 173 (26.9%), and 211 (32.8%) were in the Yes-angioedema, No-angioedema, and Misaligned category, respectively. CSU activity and impact on HRQoL, productivity, and HCRU were greater for Yes-angioedema patients than No-angioedema patients. After covariate adjustment, mean DLQI score was significantly higher (indicating worse HRQoL) for patients with angioedema versus no angioedema (9.88 vs. 7.27, P < 0.001). The Misaligned category had similar results with Yes-angioedema on all outcomes.
CONCLUSIONS: Angioedema in CSU seems to be under-reported but has significant negative impacts on HRQoL, daily activities, HCRU, and work compared with no angioedema. This article is protected by copyright. All rights reserved.
