Methods: XTEND-CIU enrolled 206 patients ≥12 years of age with CIU who were symptomatic despite standard H1 antihistamine treatment. Following a 24-week open-label period, patients were randomized to either placebo or omalizumab for an additional 24 weeks. Patients completed the following patient-reported outcome measurements: Insomnia Severity Index (ISI), Work Productivity and Activity Impairment Questionnaire (WPAI), and Generalized Anxiety Disorder 7 item (GAD-7) Scale.
Results: At baseline, patients reported severe negative effects on QOL due to CIU. During the double-blind phase (week 24 to 48), patients randomized to receive omalizumab exhibited significantly better ISI scores (mean (SD) change of 1.4 (6.0) vs. 8.8 (11.2), p<0.0001) and overall WPAI activity impairment (mean (SD) change of 6.6 (22.3) vs. 33.0 (38.0), p<0.0001) compared to placebo. Anxiety scores decreased in all patients throughout the 48-week study, and the change in mean (SD) GAD-7 was not statistically significant between groups during the double-blind period (1.19 (3.7) vs 1.65 (4.6), p=0.5360).
Conclusions: This long-term study demonstrates that patients continuing omalizumab treatment to 48 weeks exhibited significantly better patient-reported outcomes, other than anxiety, when compared to patients withdrawing treatment after 24 weeks.