INTRODUCTION AND OBJECTIVES: The ASSURE-CSU study in inadequately-controlled CSU patients assessed burden of disease and occurrence of angioedema. Here we present results of analyses of how the presence of angioedema is reported and the impact of angioedema on health-related quality of life (HRQoL).
MATERIALS AND METHODS: This observational study conducted in Canada, France, Germany, Italy, Netherlands, Spain, and the United Kingdom enrolled patients with CSU aged ≥18 years with disease persisting for ≥12 months and symptomatic despite current treatment. Data for this analysis came from medical charts, patient survey, and patient diary, focusing on presence of angioedema and HRQoL impact measured by DLQI (score 0 [low] to 30 [high impairment]). Data for angioedema within the previous 12 months from the medical charts were compared with data from the patient survey and diary to determine agreement between physician and patient on presence of angioedema. Angioedema was classified as “YES” if reported in the medical chart and either the patient survey or diary, “NO” if neither in medical record nor patient-reported and “MISALIGNED” if reported by only one source. An analysis of covariance (ANCOVA) model assessed the relationship between DLQI total score and angioedema with covariates: UAS7 score, age, sex, country, disease duration and comorbidities (hypersensitivity to nonsteroidal anti-inflammatory drugs, Hashimoto’s, asthma), comparing “YES+MISALIGNED” vs. “NO” groups, and a sensitivity analysis removing “MISALIGNED”.
RESULTS: Medical records were abstracted for 673 patients from 64 centres in the 7 countries. Among these patients, 649 (96.4%), completed the patient survey and 614 (91.2%) completed the patient diary. Mean age (SD) was 48.8 (15.47) years, 72.7% female and 90.4% Caucasian. Among the 643 patients with complete angioedema data, 259 (40.3%) were classified as “YES”, 173 (26.9%) as “NO” and 211 (32.8%) “MISALIGNED”; 98% of the “MISALIGNED” cases were reported by the patient only. The mean (SD) DLQI score was significantly higher for the “YES” (10.4 [6.85]) angioedema group compared with the “NO” group (6.6 [5.21]), p<.0001, and was similar to “YES” in the “MISALIGNED” group (9.7 [6.87]). Regression analysis confirmed that after covariate adjustment mean DLQI was significantly higher for “YES” than “NO” (9.88 vs 7.27, p<.0001). The sensitivity analysis confirmed results (9.69 vs 6.73, p<.0001).
CONCLUSIONS: Angioedema has a significant impact on HRQoL, but these findings suggest a misalignment between patients and physicians in reporting angioedema, and the need for improved education and physician-patient communication regarding angioedema in CSU.
