Adjusted Mean Difference in UAS7 (meanΔUAS7) and CU-QoL Total Score Between Visits
Table 1 and Figure 2 summarize the mean differences in UAS7 and CU-QoL between visits adjusted for the severity and the duration of disease at enrollment. The baseline UAS7 ranged from 16 to 42 between subjects, implying baseline variations in disease severity from moderate to severe CSU. The primary outcome, (i.e. the meanΔUAS7), decreased significantly 4-weeks after the 3rd benralizumab dose (visit 5) versus post-placebo (visit 2) and baseline (visit 1). Five subjects had a UAS7=0 and two had a UAS ≤6 at visit 5 or 6. The effect of benralizumab on the UAS7 was statistically and clinically significant based on the sustained mean differences between follow-up Visit 6 (i.e., 8 weeks after the last benralizumab dose) vs. the post-placebo Visit 2 (ΔUAS7=15.2 [3.2, 27.2], p=0.006) or vs. the baseline Visit 1 (ΔUAS7=17.7 [5.3, 30.1], p=0.001). Both components of the UAS7 (i.e., pruritus severity and wheal size) improved to a similar extent. The differences in CU-QoL total scores were statistically significant at several time points mostly for the pruritus and wheals components. UAS7 and CU-QoL total scores had significant positive correlation (ρ = 0.9, p<0.0001). No drug-related adverse events were reported throughout the study.