0
Original Research |

Reslizumab for Inadequately Controlled Asthma with Elevated Blood Eosinophil Levels: a Randomized Phase 3 Study OPEN ACCESS

Leif Bjermer, MD; Catherine Lemiere, MD; Jorge Maspero, MD; Sivan Weiss, MSc; James Zangrilli, MD; Matthew Germinaro, MD
Author and Funding Information

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

Conflict of Interest:

Dr Bjermer has served on advisory boards or provided lectures for Aerocrine, Airsonett, ALK, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Genentech, GlaxoSmithKline, Meda, Mundipharma, Nigaard Pharma, Novartis, Regeneron, Sanofi-Aventis, Takeda, and Teva. Dr Lemiere has served on advisory boards for GlaxoSmithKline, AstraZeneca, Teva, and Merck. Dr Maspero has served on advisory boards for Allergy Therapeutics, Sanofi, and Teva; and was involved in Speaker Bureau activities for GlaxoSmithKline, Novartis, and Uriach. Dr Weiss is an employee of Teva. Dr Zangrilli is an employee of Teva and has a patent pending on the use of reslizumab to treat moderate-to-severe eosinophilic asthma. Dr Germinaro is an employee of Teva.

Trial Registration: ClinicalTrials.gov:NCT01270464

Correspondence to: Leif Bjermer, MD, Professor, Department of Respiratory Medicine & Allergology, Skåne University Hospital, 22185 Lund, Sweden.


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


Chest. 2016. doi:10.1016/j.chest.2016.03.032
Text Size: A A A
Published online

Abstract

Background  This phase 3 study further characterizes the efficacy and safety of reslizumab (a humanized anti–interleukin-5 monoclonal antibody) in patients aged 12-75 years with asthma inadequately controlled by at least a medium-dose inhaled corticosteroid, and blood eosinophils ≥400cells/μL.

Methods  Patients were randomized to receive reslizumab 0.3 or 3.0mg/kg or placebo once/every 4 weeks/16 weeks. Primary endpoint was change from baseline in pre-bronchodilator forced expiratory volume in 1 sec (FEV1) over 16 weeks. Secondary endpoints included forced vital capacity (FVC), forced expiratory flow at 25-75% of FVC (FEF25-75%), patient-reported control of asthma symptoms, short-acting beta agonist (SABA) use, blood eosinophil levels, and safety.

Results  Reslizumab significantly improved FEV1 (difference vs placebo [reslizumab 0.3 and 3.0mg/kg]:115mL[95% CI 16-215; P= .0237] and 160mL[95% CI 60-259; P= .0018]). Clinically meaningful increases in FVC (130mL) and FEF25-75% (233mL/s) were observed with reslizumab 3.0mg/kg. Reslizumab improved Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) versus placebo (greater effects seen with 3.0mg/kg; P<0.05). The minimally important difference was reached for AQLQ (reslizumab 3.0mg/kg) but not ACQ. Asthma Symptom Utility Index and SABA use were improved with reslizumab. The most common adverse events were asthma worsening, headache, and nasopharyngitis; most were mild-to-moderate in severity.

Conclusions  Reslizumab improved lung function, asthma control and symptoms, and quality of life, and was well tolerated in patients with inadequately controlled asthma (despite standard therapy), and elevated blood eosinophils. Overall, the 3.0mg/kg dose of reslizumab provided greater improvements in asthma outcomes (vs 0.3mg/kg), with comparable safety.


This article is only available in the PDF format. Download the PDF

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543