Asthma and lower airway diseaseEffects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia
Section snippets
Study design
This was a multicenter, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov identifier: NCT00659659) conducted from April 2008 through April 2011 (Fig 1). Subjects were recruited from 3 US and 4 Canadian medical centers. All subjects signed an informed consent form before any study-related activities. The protocol was approved by local ethics committees for each site along with the US Food and Drug Administration and Health Canada.
Eligible subjects aged 18 to 65 years had a
Subjects
Twenty-seven adults with asthma were randomized to receive placebo or benralizumab (administered intravenously or subcutaneously), and all subjects were included in all analyses. Subject disposition is shown in Fig E1 in this article's Online Repository at www.jacionline.org. Twenty-six subjects completed the study. One subject randomized to 1 mg/kg intravenous benralizumab withdrew consent after receiving study drug (no reason was given) but was followed up to day 56; this subject was
Discussion
This study evaluated the safety profile of benralizumab and its effects on eosinophils in the airways, sputum, bone marrow, and peripheral blood of patients with eosinophilic asthma. Eosinophil counts were reduced in the airway mucosa after both intravenous and subcutaneous benralizumab compared with those seen after placebo. Differences between the benralizumab and placebo groups in percentage change in airway eosinophil counts were not statistically significant within cohorts but reached
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Supported by MedImmune, LLC.
Disclosure of potential conflict of interest: D. L. Gossage is a former employee of MedImmune and is currently employed by Gilead Science. G. Gauvreau, R. Leigh, and R. Katial have received research support from MedImmune. W. W. Busse is a member of the advisory board for Merck; has consultant arrangements with Amgen, Novartis, GlaxoSmithKline, MedImmune, and Genentech; and receives research support from the National Institutes of Health/National Institute of Allergy and Infectious Diseases and the National Heart, Lung, and Blood Institute. S. Wenzel has consultant arrangements with TEVA and has received research support from GlaxoSmithKline and MedImmune. Y. Wu is employed by MedImmune and has stock in AstraZeneca. V. Datta is employed by MedImmune and has stock in AstraZeneca. N. A. Molfino is a former employee of MedImmune and is currently employed by KaloBios Pharmaceuticals. The rest of the authors declare that they have no relevant conflicts of interest.
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Dr Gossage is currently employed at Gilead Sciences, Seattle, Wash.
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Dr Molfino is currently employed at KaloBios Pharmaceuticals, San Francisco, Calif.