3100 Omalizumab improved symptoms in all three phase III trials conducted in patients with inadequately controlled chronic spontaneous/idiopathic urticaria (CSU/CIU): A post-hoc analysis of percent change from baseline

Friday, 16 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Thomas Casale , University of South Florida, Tampa, FL

Marcus Maurer , Dermatology and Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany

Sarbjit Saini , Medicine, Johns Hopkins University, Baltimore, MD

Jonathan Bernstein , Internal Medicine, University of Cincinnati, Cincinnati, OH

Allen Kaplan , Medicine, Medical University of South Carolina, Charleston, SC

Karin Rosen , Genentech Inc., San Francisco, CA

Sam Khalil , Novartis Pharmaceuticals AG, Basel, Switzerland

Rowan Higgs , Global Medical & Clinical Services, Novartis Pharma AG, Ireland

Background: Omalizumab, an anti-IgE monoclonal antibody, was evaluated in refractory CSU/CIU patients; here we report itch and hive symptom data from three Phase III trials (ASTERIA I/II & GLACIAL).

Methods: Patients in ASTERIA I/II, symptomatic despite approved doses of H1-antihistamines, were randomized to omalizumab 75/150/300 mg or placebo. Patients in GLACIAL who were symptomatic despite H1-antihistamines (up to 4x approved dose) plus H2-antihistamines, leukotriene-receptor antagonists or both, received omalizumab 300 mg or placebo. Itch severity scores and weekly number of hives scores for omalizumab 150/300 mg and placebo groups were analysed as relative percentage change and absolute change from baseline to Week 12. P-values are for absolute values relative to placebo and derived using ANCOVA t-test. Omalizumab 75 mg data are not presented.

Results: Itch severity and weekly number of hives scores (% [absolute]) were significantly improved from baseline for omalizumab 300 and 150 mg vs placebo at Week 12, across all Phase III studies.

Itch severity scores: omalizumab 300 / 150 mg vs placebo

  • ASTERIA I (n=318): 67% [-9.4] / 48% [-6.7] vs 26% [-3.6]; p<0.0001 / p=0.0012
  • ASTERIA II (n=322): 71% [-9.8] / 56% [-8.1] vs 36% [-5.1]; p<0.001 / p<0.01
  • GLACIAL (n=335): 62% [-8.6] vs 26% [-4.0]; p<0.001

Weekly number of hives scores: omalizumab 300 / 150 mg vs placebo

  • ASTERIA I (n=318): 67% [-11.4] / 50% [-7.8] vs 25% [-4.4]; p<0.0001 / p=0.0017
  • ASTERIA II (n=322): 74% [-12.0] / 57% [-9.8] vs 31% [-5.2]; p<0.001 / p<0.01
  • GLACIAL (n=335): 62% [-10.5] vs 27% [-4.5]; p<0.001

No new safety signals were identified.

Conclusions: In all three Phase III studies, omalizumab improved symptoms in this post-hoc analysis of patients with inadequately controlled CSU/CIU; omalizumab 300 mg consistently showed the greatest improvements.