Analysis of disease activity categories in chronic spontaneous/idiopathic urticaria

Abstract

Summary Background Measurement of disease activity guides treatment of chronic spontaneous urticaria (CSU). A weekly Urticaria Activity Score – here, the average of twice‐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 were pooled. 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 increase in angioedema frequency. Results at different treatment time points were consistent. Conclusions Categorical UAS7TD disease states can discriminate between measures when considering the impact of urticaria activity. Using five categorical disease states could simplify clinical assessment and monitoring of treatment efficacy.

Effectiveness of omalizumab in chronic spontaneous urticaria assessed with patient‐reported outcomes: a prospective study

“…The score is summed over 7 days giving a UAS7 score of 0 to 42 points. A UAS7 score of ≤6 corresponds to minimal disease activity; a UAS7 score of 7–15 indicates mild urticaria, a score of 16–27 points indicates moderate urticaria, whereas severe urticaria is characterized by a UAS7 score of 28–42 points . The minimal clinically important difference in UAS7 is equivalent to 10 points .…”

“…A UAS7 score of ≤6 corresponds to minimal disease activity; a UAS7 score of 7-15 indicates mild urticaria, a score of 16-27 points indicates moderate urticaria, whereas severe urticaria is characterized by a UAS7 score of 28-42 points. 18 The minimal clinically important difference in UAS7 is equivalent to 10 points. 19,20 The UCT is a retrospective 4-item questionnaire, which documents control of urticaria in the past 4 weeks.…”

Omalizumab Updosing for Better Disease Control in Chronic Spontaneous Urticaria Patients

“…The weekly urticaria activity score (UAS7) and/or the Urticaria Control Test (UCT) were used to monitor the response. Urticaria control was defined as having UCT ≥12, well-controlled activity as UAS7 < 6, and complete control and controlled activity was defined as UCT = 16 and UAS7 = 0 [2, 3]. …”

Cost-effectiveness of omalizumab for the treatment of chronic spontaneous urticaria

“…The UAS7 score uses a daily diary measuring itches and hives over a period of 7 days. The score is continuous, ranging from 0 to 42, but it can be divided into categories to reflect different levels of disease activity . The model consisted of five health states: urticaria free (score of 0), well‐controlled urticaria (1–6), mild urticaria (7–15), moderate urticaria (16–27) and severe urticaria (28–42).…”