Impact Of Omalizumab On Patient Reported Outcomes In Chronic Idiopathic Urticaria: Results From XTEND-CIU, A 48-Week, Randomized, Placebo-Controlled Study

Rationale: Chronic idiopathic urticaria (CIU) is reported to have a major impact on quality of life (QOL) comparable to that experienced by patients with coronary artery disease awaiting bypass surgery. Patients with CIU often experience sleep deprivation, psychiatric comorbidity, and work-activity impairment. In the double-blind phase of the XTEND-CIU study, we explored the effects of CIU on QOL and the potential of omalizumab to improve these measures.

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.