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

Thomas B. Casale, Jonathan A. Bernstein, Marcus Maurer, Sarbjit S. Saini, Benjamin Trzaskoma, Hubert Chen, Clive E. Grattan, Ana Gimenéz-Arnau, Allen P. Kaplan, Karin Rosén

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)743-750.e1
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume3
Issue number5
DOIs
StatePublished - Sep 1 2015

Keywords

  • Antihistamine
  • Chronic idiopathic
  • Chronic spontaneous
  • Hive
  • Itch
  • Omalizumab
  • Pruritus
  • Urticaria
  • Wheal

ASJC Scopus subject areas

  • Immunology and Allergy

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  • Cite this

    Casale, T. B., Bernstein, J. A., Maurer, M., Saini, S. S., Trzaskoma, B., Chen, H., Grattan, C. E., Gimenéz-Arnau, A., Kaplan, A. P., & Rosén, K. (2015). Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. Journal of Allergy and Clinical Immunology: In Practice, 3(5), 743-750.e1. https://doi.org/10.1016/j.jaip.2015.04.015