Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy

J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.


Background: Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242).

Objective: The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis.

Methods: Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies.

Results: Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma.

Conclusion: Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.

Trial registration: NCT01264939 NCT01287117 NCT01292473.

Keywords: Antihistamine; Chronic idiopathic; Chronic spontaneous; Hive; Itch; Omalizumab; Pruritus; Urticaria; Wheal.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Analysis of Variance
  • Chronic Disease
  • Drug Dosage Calculations
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Histamine H1 Antagonists / administration & dosage*
  • Histamine H1 Antagonists / adverse effects
  • Histamine H2 Antagonists / administration & dosage*
  • Histamine H2 Antagonists / adverse effects
  • Humans
  • Immunotherapy / methods*
  • Male
  • Middle Aged
  • Omalizumab / administration & dosage*
  • Omalizumab / adverse effects
  • Recurrence
  • Treatment Outcome
  • Urticaria / immunology
  • Urticaria / therapy*


  • Histamine H1 Antagonists
  • Histamine H2 Antagonists
  • Omalizumab

Associated data