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Original Research |

Phase 3 Study of Reslizumab in Patients with Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts OPEN ACCESS

Jonathan Corren, MD; Steven Weinstein, MD; Lindsay Janka; James Zangrilli, MD; Margaret Garin, MD
Author and Funding Information

Funding: The study was funded by Teva Branded Pharmaceutical Products R&D, Inc.

Conflict of Interest: Dr Corren has been involved in speaker bureau activities for Genentech and Merck and has served on advisory boards for Vectura Pharmaceuticals, Genentech, Novartis and Merck. Dr Weinstein has received research grants from AstraZeneca, and was involved in speaker bureau activities and advisory boards for Teva; these activities were outside of the submitted work. Ms Lindsay Janka and Dr Garin are employees of Teva and have shareholdings in Teva. Dr Zangrilli is an employee of Teva, and has a patent pending for the use of reslizumab to treat moderate-to-severe asthma.

Trial registration: ClinicalTrials.gov, NCT01508936

Correspondence To: Jonathan Corren, MD, 10780 Santa Monica Blvd., Suite 280, Los Angeles, CA 90025, USA.


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.03.018
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Abstract

Background  Interleukin-5 (IL-5), a mediator of eosinophil activity, is an important potential treatment target in patients with uncontrolled asthma. The efficacy of reslizumab, a humanized anti-human IL-5 monoclonal antibody, has been characterized in patients with blood eosinophils ≥400cells/μL. This study further characterizes the efficacy and safety of reslizumab in patients with poorly-controlled asthma, and those with eosinophils <400cells/μL.

Methods  Patients were randomized to intravenous reslizumab 3.0mg/kg or placebo once every 4 weeks for 16 weeks. Primary endpoint was the change in forced expiratory volume in 1 second (FEV1) from baseline to week 16. Secondary measures included Asthma Control Questionnaire-7 (ACQ-7) scores, use of short-acting beta-agonists (SABAs), and forced vital capacity (FVC).

Results  492 patients received ≥1 dose of placebo (n=97) or reslizumab (n=395). In the overall population, mean FEV1 change from baseline to week 16 was not significantly different between reslizumab and placebo and no significant relationship was detected between baseline blood eosinophils and change in FEV1. In the subgroup of patients with baseline eosinophils <400cells/μL, patients treated with reslizumab showed no significant improvement in FEV1 compared with placebo. In the subgroup with eosinophils ≥400cells/μL, however, treatment with reslizumab was associated with much larger improvements in FEV1, ACQ-7, rescue SABA use and FVC compared with placebo. Reslizumab was well tolerated, with fewer overall adverse events compared with placebo (55% vs 73%).

Conclusion  Reslizumab was well tolerated in patients with inadequately controlled asthma. Clinically meaningful effects on lung function and symptom control were not seen in patients unselected for baseline eosinophils.


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