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Monoclonal antibody appears effective and safe in asthma Phase IIa trial
Date:5/21/2013

ficant improvements were also reported for other relevant asthma outcomes such as lung function as assessed by forced expiratory volume in one second (FEV1) and morning peak expiratory flow, asthma symptoms and control, as well as, asthma reliever medication use. Many of these improvements were seen when dupilumab was added to ICS/LABA, with efficacy maintained despite background therapy withdrawal.

"Intriguingly," noted Dr. Wenzel, "dupilumab showed substantial efficacy in objective and patient-reported endpoints when added to ICS and LABA and when those therapies were discontinued."

Patients in the study received dupilumab or placebo added to their regular, twice daily dose of fluticasone/salmeterol. At Week 4, patients were instructed to withdraw the LABA (salmeterol). Between Weeks 6 and 9, they tapered off fluticasone, the ICS.

A total of 104 patients, aged 18 to 65, participated in the study. Half received the monoclonal antibody; half received placebo. All had persistent, moderate-to-severe asthma that was not well-controlled by medium to high doses of combined ICS and LABA therapy. The patients also had elevated blood (≥ 300 cells/l) or sputum (≥3%) eosinophils at screening.

The study found no clear change in blood eosinophils with dupilumab therapy; however, other biomarkers decreased, including fractional exhaled nitric oxide, thymus and activation regulated chemokine, immunoglobulin E and eotaxin-3, confirming the biologic activity of dupilumab.

Side effects occurring more frequently in the patients receiving the monoclonal antibody vs. placebo included injection site reactions, nasopharyngitis, nausea and headache, but were not considered severe.

According to Dr. Wenzel, the current study, exhibited a "magnitude and breadth" of efficacy that exceeded other studies of cytokine inhibition in asthma. She and her investigator colleagues speculate that the stronger outcome came as a re
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Contact: Nathaniel Dunford
ndunford@thoracic.org
American Thoracic Society
Source:Eurekalert

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