The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU

Abstract

Background: Chronic spontaneous urticaria (CSU) can be debilitating, difficult to treat, and frustrating for patients and physicians. Real-world evidence for the burden of CSU is limited. The objective of this study was to document disease duration, treatment history, and disease activity, as well as impact on health-related quality of life (HRQoL) and work among patients with inadequately controlled CSU, and to describe its humanistic, societal, and economic burden.

Methods: This international observational study assessed a cohort of 673 adult patients with CSU whose symptoms persisted for ≥12 months despite treatment. Demographics, disease characteristics, and healthcare resource use in the previous 12 months were collected from medical records. Patient-reported data on urticaria and angioedema symptoms, HRQoL, and work productivity and activity impairment were collected from a survey and a diary.

Results: Almost 50% of patients had moderate-to-severe disease activity as reported by Urticaria Activity Score. Mean (SD) Dermatology Life Quality Index and Chronic Urticaria Quality of Life Questionnaire scores were 9.1 (6.62) and 33.6 (20.99), respectively. Chronic spontaneous urticaria markedly interfered with sleep and daily activities. Angioedema in the previous 12 months was reported by 66% of enrolled patients and significantly affected HRQoL. More than 20% of patients reported ≥1 hour per week of missed work; productivity impairment was 27%. These effects increased with increasing disease activity. Significant healthcare resources and costs were incurred to treat CSU.

Conclusions: Chronic spontaneous urticaria has considerable humanistic and economic impacts. Patients with greater disease activity and with angioedema experience greater HRQoL impairments.

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

Figure 1

Study measures. AE‐QoL=Angioedema Quality of Life Questionnaire; CU‐Q₂oL=Chronic Urticaria Quality of Life Questionnaire; d=days; DLQI=Dermatology Life Quality Index; UAS7=Urticaria Activity Score over 7 days, twice‐daily assessment; UPDD=Urticaria Patient Daily Diary; WPAI‐SHP=Work Productivity and Activity Impairment‐Specific Health Problem

Figure 2

Urticaria Activity Score over 7 d (UAS7). SD=standard deviation; UAS7=Urticaria Activity Score over 7 d, twice‐daily assessment. Note: UAS7 scores were assessed by summing the average of twice‐daily assessments of hive count and itch score and summing these daily scores over 7 d

Figure 3

Impact of CSU on HRQoL, sleep, and daily life. (A). CU‐Q₂oL total and domain scores, overall and by disease activity^a,b. (B). DLQI domain scores, overall and by disease activity^c. (C). Moderate and extreme problems on EQ‐5D‐3L domains, overall and by disease activity^c,d. (D). Interference with sleep and interference with daily activities, overall and by disease activity^c,e. CSU=chronic spontaneous urticaria; CU‐Q₂oL=Chronic Urticaria Quality of Life Questionnaire; DLQI=Dermatology Life Quality Index; SD=standard deviation; UAS7=Urticaria Activity Score over 7 d, twice‐daily assessment. ^a CU‐Q₂oL results exclude Germany, where the domains differ. Results for Germany can be found in Table S4 in Appendix S4. ^bNs in legend represents the total number of survey completers in each UAS7 score band. Some of these patients had insufficient data to calculate an overall score and/or individual domain scores. ^cNs in legends represents the total number of survey completers in each UAS7 score band. Some of these patients had insufficient data to calculate domain scores. ^dPatterned bars indicate the percentage of patients overall or in each score band with moderate problems, and solid bars indicate the percentage of patients overall in each score band with extreme problems. ^eWeekly score is calculated as the sum of daily sleep or daily interference scores (range of 0 [no interference] to 3 [substantial interference]), divided by the number of nonmissing daily scores, multiplied by 7

Figure 4

AE‐QoL domain scores, overall and by disease activity. AE‐QoL=Angioedema Quality of Life Questionnaire; UAS7=Urticaria Activity Score over 7 d, twice‐daily assessment. Ns in legend represents the total number of patients in each UAS7 score band who reported angioedema over the past 4 wk in the patient survey. Some patients had insufficient data to calculate one or more AE‐QoL domain scores

Figure 5

Therapies used in the past 12 mo (N=673). LTRA=leukotriene receptor antagonists. Other immunosuppressants included methotrexate and mycophenolate mofetil; other specified therapies included intravenous immunoglobulin, narrowband ultraviolet B procedure, dapsone, hydroxychloroquine, levamisole, mesalazine, sulfasalazine, nifedipine, stanozolol, and warfarin. Multiple H₁‐antihistamines included combinations of second‐ and/or third‐generation H₁‐antihistamine therapies, as well as patients who have multiple records of the same H₁‐antihistamine