FREEDOM FROM ITCH AND HIVES IN CHRONIC SPONTANEOUS URTICARIA IS ASSOCIATED WITH IMPROVED QUALITY-OF-LIFE MEASURES

Abstract

<h3>Introduction</h3> Patients' sleep, daily activities, and work are negatively impacted in chronic spontaneous urticaria. We evaluated the association between complete response (Urticaria Activity Score [UAS7]=0) and various patient reported outcomes (PRO) using the ligelizumab Phase 2b data (NCT02477332). <h3>Methods</h3> Data from patients treated with ligelizumab 72mg or 240mg, omalizumab 300mg, or placebo every 4 weeks for 20 weeks were used for this analysis. The percentage of evaluations achieving Weekly Sleep Interference Score (SIS7)=0 response, Weekly Activity Interference (WAI)=0 response, and Overall Work Impairment (OAI)=0 response per UAS7 disease activity band (wheal and itch free=0, well-controlled=1–6, mild=7–15, moderate=16–27 and severe=28–42) were assessed. Odds ratios (ORs), 95% confidence intervals, and nominal P values for UAS7=0 (complete response) vs UAS7=1–6 (well-controlled disease) were estimated. <h3>Results</h3> Data from 382 patients were analyzed. At any timepoint, UAS7=0 was strongly associated with evaluations of complete response on other PROs: 99.7% (total number of evaluations [N]=2,895) with SIS7=0; 99.7% (N=2,898) with WAI=0; and 85.3% (N=209) with OWI=0. In patients with UAS7=0 vs. those with UAS7 1–6, there was 137 times (95% CI 37.2 – 502.8) higher likelihood of having SIS7=0, 178 times (95% CI 29.2 – 1085.8) higher likelihood of having WAI=0, and 3 times (95% CI 1.8 – 5.1) higher likelihood of having OWI=0. <h3>Conclusion</h3> Control of urticaria symptoms leads to improvements in daily activities, sleep, and work, with best outcomes observed in patients with complete response to treatment.