Abstract
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.
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