@article{1ac379d0fb1d4ee0967bacffebbec1d7,
title = "Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy",
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.",
keywords = "Antihistamine, Chronic idiopathic, Chronic spontaneous, Hive, Itch, Omalizumab, Pruritus, Urticaria, Wheal",
author = "Casale, {Thomas B.} and Bernstein, {Jonathan A.} and Marcus Maurer and Saini, {Sarbjit S.} and Benjamin Trzaskoma and Hubert Chen and Grattan, {Clive E.} and Ana Gimen{\'e}z-Arnau and Kaplan, {Allen P.} and Karin Ros{\'e}n",
note = "Funding Information: Conflicts of interest: T. B. Casale has received research support and consultancy fees from Novartis and Genentech. J. A. Bernstein has received research support from Novartis; has received speakers fees from Novartis/Genentech. M. Maurer has received research and travel support, and consultancy fees from Novartis and Genentech. S. S. Saini has received research support and consultancy fees from Genentech; has received consultancy fees from MedImmune; has received research support from the Immune Tolerance Network, Novartis, and AstraZeneca; and receives royalties from UpToDate. B. Trzaskoma and K. Rosen are employed by and has stock/stock options in Genentech. H. Chen is employed by Genentech and owns Roche stock options. C. E. Grattan has received consultancy fees from RTI Health Solutions, Genentech, and GlaxoSmithKline; has received lecture fees from Novartis; and is DSMB Chair for CSL Behring. A. Gimen{\'e}z-Arnau has received consultancy fees and fees for participation in review activities from Genentech; has received consultancy fees and research support from Novartis, Uriach Pharma, and Almirall; and has received lecture fees from Uriach, Menarini, Novartis, Almirall, and GlaxoSmithKline. A. P. Kaplan has received consultancy fees from Genentech; has received research support from Genentech, Dyax, and Shire; has received lecture fees from Dyax and Shire; and has a patent with Dyax. Original Article Funding Information: The authors would like to acknowledge former Novartis employee Janice Canvin for her invaluable contributions to the study design, data collection, and analysis, and interpretation of the results. Support for third-party writing assistance for this manuscript was provided by Genentech, Inc., and Novartis Pharma AG. Medical writing support for this manuscript was provided by Alison Gagnon and Charlotte Kenreigh of Excel Scientific Solutions and funded by Genentech, Inc., and Novartis Pharmaceuticals Corporation. Publisher Copyright: {\textcopyright} 2015 The Authors.",
year = "2015",
month = sep,
day = "1",
doi = "10.1016/j.jaip.2015.04.015",
language = "English (US)",
volume = "3",
pages = "743--750.e1",
journal = "Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "American Academy of Allergy, Asthma and Immunology",
number = "5",
}