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Background: Measurement of disease activity guides treatment of chronic spontaneous urticaria (CSU). A weekly Urticaria Activity Score–here, the average oftwice-daily patient assessment of itch and hives scores summed over 1 week(UAS7TD)–measures severity from 0 to 42. Insufficient evidence exists on whether disease activity states, defined by categorical UAS7TD scores, correlate with other patient-reported outcomes and treatment response.

Objectives: To evaluate and compare categorical UAS7TD scores with selected measures of disease-related quality of life and impact.

Methods: Data from three randomized clinical trials of omalizumab in CSU werepooled. Continuous UAS7TD scores were categorized into five disease activity states:urticaria-free, well-controlled, mild, moderate and severe urticaria. Total scores from the Dermatology Life Quality Index; the Chronic Urticaria Quality of Life questionnaire; and questions on sleep and daily activity interference, presence of angioedema and diphenhydramine use were compared within categorized UAS7TD disease-state scores, using ANOVA for analysis at different time points and mixed-effects regressions for analysis of all data pooled.

Results: Pooled analyses showed that categorical UAS7TD disease states accurately predicted differences among treated patients with CSU with different levels of disease activity. A consistent pattern existed between categories, with higher-activity disease states associated with significantly higher impact and an increasein angioedema frequency. Results at different treatment time points wereconsistent.

Conclusions: Categorical UAS7TD disease states can discriminate between measures when considering the impact of urticaria activity. Using five categorical diseasestates could simplify clinical assessment and monitoring of treatment efficacy.