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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 ( HRQ oL), productivity and healthcare resource utilization ( 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  HRQ oL, productivity, and  HCRU  was greater for  Yes‐angioedema  patients than  No‐angioedema  patients. After covariate adjustment, mean  DLQI  score was significantly higher (indicating worse  HRQ oL) for patients with angioedema versus no angioedema (9.88 vs 7.27,  P  < .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  HRQ oL, daily activities,  HCRU  and work compared with no angioedema.

Angioedema in chronic spontaneous urticaria is underdiagnosed and has a substantial impact: Analyses from ASSURE ‐ CSU