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

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 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 HRQoL, productivity, and HCRU was 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 < .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.

Keywords: angioedema; economic burden; observational study; quality of life; urticaria.

Figure 1

Frequency of angioedema in the past 12 months. (A) Initial frequency: Angioedema in the past 12 months was more frequently reported by patients who completed the survey (65.8%, 427/649 patients) than recorded in the medical record (41.0%, 276/673 patients). (B) Revised frequency: Of the 32.8% of patients (211/643) with misaligned reporting of angioedema in the past 12 months, 97.2% (205/211) reported having had angioedema when it was not noted in the medical record

Figure 2

Mean urticaria activity score over 7 days, twice‐daily assessment (UAS7_TD), by angioedema classification. UAS7_TD scores were calculated by summing the average of twice‐daily assessments of hive count and itch score and summing these daily scores over 7 days. *P < .01 (Yes—angioedema vs No—angioedema). Patients who fell into the Misaligned group were not included in the statistical comparisons. SD, standard deviation. [Colour figure can be viewed at http://www.wileyonlinelibrary.com/]

Figure 3

Impact of CSU on HRQoL, sleep and daily activities, overall and by angioedema classification. (A) CU‐Q₂oL total and domain scores. Different CU‐Q₂oL scale scores are used in Germany than in Canada, France, Italy, the Netherlands, Spain and the UK. German CU‐Q2oL overall score and scale scores are presented in Figure S2; (B) DLQI total score; (C) DLQI domain scores; (D) Interference with sleep and interference with daily activities over a week, as reported on the Urticaria Patient Daily Diary, by angioedema classification. For all scores, a higher score means higher impairment. *P < .001 (Yes—angioedema vs No—angioedema); **P < .05 (Yes—angioedema vs No—angioedema). Patients who fell into the misaligned category were not included in the statistical comparisons. CU‐Q₂oL, Chronic Urticaria Quality of Life Questionnaire; DLQI, Dermatology Life Quality Index; HRQoL, health‐related quality of life; SD, standard deviation. [Colour figure can be viewed at http://www.wileyonlinelibrary.com/]

Figure 4

Work productivity and activity impairment (WPAI) results by angioedema classification. Absenteeism was defined as percentage of work time missed due to chronic spontaneous urticaria (CSU) in the past 7 days. Presenteeism was defined as percentage impairment while working due to CSU in the past 7 days. Overall work impairment was defined as percentage work impairment due to CSU in the past 7 days, incorporating both absenteeism and presenteeism using the following validated WPAI algorithm: overall work impairment = absenteeism + (1‐absenteeism)*presenteeism. *P < .001 (Yes—angioedema vs No—angioedema); **P < .05 (Yes—angioedema vs No—angioedema). Patients who fell into the misaligned category were not included in the statistical comparisons. SD, standard deviation; WPAI, Work Productivity and Activity Impairment. [Colour figure can be viewed at http://www.wileyonlinelibrary.com/]