OBJECTIVES: This study sought to evaluate the clinical relevance of score categories from the weekly Urticaria Activity Score (UAS7) that are used to define disease activity states in chronic spontaneous urticaria (CSU).
METHODS: Mixed methods were used to evaluate UAS7 disease activity score categories: 0=urticaria free; 1-6=well-controlled; 7-15=mild activity; 16-27=moderate activity; and 28-42=severe activity. Qualitative interviews were conducted to evaluate perceived meaningfulness of UAS7 scores from the patient perspective. Initial data from two phase 3 clinical trials in adults with CSU (REMIX-1 [NCT05030311] and REMIX-2 [NCT05032157]) were used to evaluate differences (analysis of variance) between UAS7 categories in scores on the Dermatology Life Quality Index (DLQI), Urticaria Control Test 7-day recall version (UCT7), Patient Global Impression of Severity, activity and sleep interference, and rescue-medication use.
RESULTS: The 15 interview participants were aged 21-68 years (mean [standard deviation]=42.7 [13.1]) and 86.7% were female). When reviewing UAS7 scores, participants indicated that scores of 0 and 6 represent urticaria that is controlled. Compared with higher scores, these scores were considered to have meaningful benefits in the level of discomfort experienced, impact on daily life and sleep, mental and emotional well-being, and use of treatments. Trial data (n=889 at baseline, n=882 at week 2, n=743 at week 12; at baseline 66.3% were female; mean [standard deviation] age=43.4 [14.3] years) showed differences (P < 0.0001) between the UAS7 categories on all measures. Notably, being urticaria free (UAS7=0) or well-controlled (UAS7=1-6) were associated with no or minimal health-related quality of life impact on the DLQI and well-controlled urticaria on the UCT7.
CONCLUSIONS: The UAS7 disease activity categories reflect meaningful differences in patients’ experiences of symptoms, health-related quality of life, activities and sleep, and medication use. Qualitative feedback from patients confirmed that being urticaria free or well-controlled on the UAS7 has meaningful benefits from the patient perspective.
