OBJECTIVES: Chronic spontaneous urticaria (CSU) is a dermatological condition characterized by spontaneous occurrence of itchy hives and/or angioedema for ≥ 6 weeks. Five disease activity (health) states were previously defined. EQ-5D may not capture overall negative disease impact. This study assessed the EQ-5D-5L utility scores associated with health states and with angioedema in CSU.

METHODS: Pooled data came from two 52-week, phase 3, randomized controlled trials in adults with CSU (PEARL 1 & 2). Health status was assessed with EQ-5D-5L completed at baseline and every 4 weeks and also triggered by angioedema occurrence. Utility scores were estimated using UK tariffs. Disease activity was measured daily with Urticaria Activity Score (UAS); weekly (UAS7) scores were utilized to define health states, severe activity (UAS7 = 28-42), moderate (16-27), mild (7-15), well-controlled (1-6), urticaria-free (UAS7=0). A mixed model using visit and event driven data for adults was fit with utilities at follow-up as dependent variable; covariates included health state and angioedema status at visit. Marginal means (95% CIs) are reported by health state and angioedema status.

RESULTS: Data from 1,902 patients, mean (SD) age 42.7 (13.5) years, 71.4% female were used. For those without angioedema, mean (95% CI) utility scores for each health state from severe to urticaria‑free were 0.713 (0.703-0.723), 0.812 (0.802-0.821), 0.869 (0.861-0.878), 0.907 (0.898-0.916), 0.930, (0.922-0.937) respectively and for those with angioedema, were 0.621 (0.612-0.631), 0.720 (0.710-0.730), 0.778 (0.768-0.788), 0.815 (0.804-0.827), and 0.838 (0.827-0.849), respectively. Based on the model, for all health states, utility scores are predicted to be lower by a mean of 0.092 for those with angioedema compared to without.

CONCLUSIONS: This analysis shows that, by using enhanced collection of EQ-5D-5L, linked to occurrence of specific events (e.g angioedema), the negative impact on health status is captured. Higher disease activity and angioedema were associated with lower utility scores.