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

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Urticaria
Therapeutics
Histamine Antagonists
Placebos
Omalizumab
Safety
Asthma
Databases

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. / Casale, Thomas B.; Bernstein, Jonathan A.; Maurer, Marcus; Saini, Sarbjit S; Trzaskoma, Benjamin; Chen, Hubert; Grattan, Clive E.; Gimenéz-Arnau, Ana; Kaplan, Allen P.; Rosén, Karin.

In: Journal of Allergy and Clinical Immunology: In Practice, Vol. 3, No. 5, 01.09.2015, p. 743-750.e1.

Research output: Contribution to journalArticle

Casale, TB, Bernstein, JA, Maurer, M, Saini, SS, Trzaskoma, B, Chen, H, Grattan, CE, Gimenéz-Arnau, A, Kaplan, AP & Rosén, K 2015, 'Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy', Journal of Allergy and Clinical Immunology: In Practice, vol. 3, no. 5, pp. 743-750.e1. https://doi.org/10.1016/j.jaip.2015.04.015
Casale, Thomas B. ; Bernstein, Jonathan A. ; Maurer, Marcus ; Saini, Sarbjit S ; Trzaskoma, Benjamin ; Chen, Hubert ; Grattan, Clive E. ; Gimenéz-Arnau, Ana ; Kaplan, Allen P. ; Rosén, Karin. / Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. In: Journal of Allergy and Clinical Immunology: In Practice. 2015 ; Vol. 3, No. 5. pp. 743-750.e1.
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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.",
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AU - Saini, Sarbjit S

AU - Trzaskoma, Benjamin

AU - Chen, Hubert

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N2 - 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.

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