Improvements In Health-Related Quality Of Life From Asteria I & II: Phase III Studies To Evaluate The Efficacy and Safety Of Omalizumab In Patients With Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment

Abstract

To describe changes in health-related quality of life (HRQOL) in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) using pooled data from the 12-week treatment periods of the ASTERIA I & II studies. Subjects (n=640) were randomized 1:1:1:1 and received placebo or omalizumab 75, 150 or 300 mg (PLB, OMA75, OMA150, OMA 300) at Baseline and Weeks 4 and 8. HRQOL was assessed by the Dermatology Life Quality Index (DLQI; overall score and subscales for symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment) at Baseline, Weeks 4 and 12. At Baseline, patients reported substantial HRQOL impairment. All treatment arms improved from Baseline to Week 12 in many of the DLQI domains; however, the largest improvements were seen in the omalizumab-treated patients (change from Baseline to Week 12 in overall DLQI, PLB -6.11, OMA75 -6.93, OMA150 -8.15, OMA300 -10.22). Compared to placebo, change from Baseline to Week 12 in overall DLQI was statistically significant for higher doses of omalizumab (OMA150, p=0.01 and OMA300 mg, p< 0.0001). Improvements in DLQI were observed after one administration of study drug, by the first post-Baseline assessment at Week 4, with additional improvement observed at Week 12. For all DLQI domains assessed, the greatest improvements were seen in patients treated with omalizumab 300 mg. In CIU/CSU patients who are symptomatic despite H1 antihistamine treatment, omalizumab was efficacious in improving a broad array of HRQOL domains, as measured by the DLQI instrument.