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Benralizumab: for Eosinophilic asthma

Takehiro Izumo, Yuriko Terada, Mari Tone, Minoru Inomata, Naoyuki Kuse, Nobuyasu Awano, Atsuko Moriya, Tatsunori Jo, Hanako Yoshimura, Yoshiaki Furuhata
Severe bronchial asthma is a chronic disorder of the airways that may be accompanied by comorbid diseases. Invasive treatment, including surgery, in patients with severe asthma has limitations depending on the degree of control of the asthma. A 71-year-old woman was diagnosed with squamous cell carcinoma with high programmed death-ligand 1 (PD-L1) expression and cT3N0M1a. After 13 cycles of pembrolizumab every 3 weeks, chest computed tomography (CT) revealed a dramatic decrease in the lesion size in the left upper lobe, but the size of the lesion in the right lower lobe was significantly increased...
2019: Respiratory Medicine Case Reports
Li Yan, Bing Wang, Yen Lin Chia, Lorin K Roskos
INTRODUCTION: Benralizumab, an interleukin-5 receptor alpha-directed cytolytic anti-eosinophil monoclonal antibody, was recently approved as add-on maintenance treatment for patients aged 12 years and older with uncontrolled asthma with eosinophilic inflammation. METHODS: Pharmacokinetic (PK) data from nine clinical trials for patients with asthma were pooled and analyzed to further characterize the PK of benralizumab and evaluate demographic covariate effects...
March 11, 2019: Clinical Pharmacokinetics
William W Busse
Asthma is a heterogeneous disease with considerable variability noted in disease severity, patterns of airway inflammation, and achievement of disease control on current medications. An absence of disease control is most frequently noted in patients with severe asthma, and is defined as a lack of control while on high dose inhaled corticosteroids (ICS) plus a second controller medication. In part, this lack of control may relate to a diminished effect of current guideline-directed care on the existing pattern of airway inflammation in severe asthma...
February 18, 2019: Allergology International: Official Journal of the Japanese Society of Allergology
Sean O'Quinn, Xiao Xu, Ian Hirsch
Background: Patients with severe, uncontrolled asthma experience debilitating symptoms that result in meaningful reductions to health-related quality of life. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that reduces exacerbations and improves asthma symptoms for patients with severe, uncontrolled eosinophilic asthma. Objective: The objective of this study was to evaluate improvements in daily asthma-related health status outcomes following treatment with benralizumab...
2019: Journal of Asthma and Allergy
Yen Lin Chia, Li Yan, Binbing Yu, Bing Wang, Peter Barker, Mitchell Goldman, Lorin Roskos
We evaluated the relationship between benralizumab (30 mg every 4 and 8 weeks [Q4W, Q8W]) pharmacokinetic (PK) exposure and endpoints of asthma exacerbation rates (AER) and change from baseline in prebronchodilator forced expiratory volume in 1 second (FEV1 ) for patients with severe, uncontrolled eosinophilic asthma in the SIROCCO/CALIMA Phase III trials. In empirical assessment, AER ratios in SIROCCO were similar across PK quartiles. However, the lowest PK quartile in CALIMA had reduced efficacy; low CALIMA placebo AER possibly confounded this result...
January 19, 2019: Clinical Pharmacology and Therapeutics
Sriram Sridhar, Hao Liu, Tuyet-Hang Pham, Gautam Damera, Paul Newbold
BACKGROUND: Benralizumab, a humanized, afucosylated, monoclonal antibody that targets interleukin-5 receptor α, depletes eosinophils and basophils by enhanced antibody-dependent cell-mediated cytotoxicity. It demonstrated efficacy for patients with moderate to severe asthma and, in a Phase IIa trial, for chronic obstructive pulmonary disease (COPD) with eosinophilic inflammation. We investigated effects of benralizumab 100 mg every 8 weeks (first three doses every 4 weeks) subcutaneous on blood inflammatory markers through proteomic and gene-expression analyses collected during two Phase II studies of patients with eosinophilic asthma and eosinophilic COPD...
January 18, 2019: Respiratory Research
Pamela L Zeitlin, Mila Leong, Jeremy Cole, Raburn M Mallory, Vivian H Shih, Richard F Olsson, Mitchell Goldman
Background and objectives: Benralizumab is a humanized, afucosylated monoclonal antibody against the IL-5Rα. Initial monthly followed by every-other-month injections result in rapid and nearly complete eosinophil depletion. We evaluated whether three doses of benralizumab modifies antibody response to seasonal influenza vaccination for adolescent/young adult patients with moderate to severe asthma. Methods: ALIZE (NCT02814643) was a Phase IIIb randomized controlled trial of patients aged 12-21 years receiving medium- to high-dosage inhaled corticosteroids/long-acting β2 -agonists...
2018: Journal of Asthma and Allergy
L Brussino, E Heffler, C Bucca, S Nicola, G Rolla
Asthma is a chronic and heterogeneous disease, which is defined as severe disease whenever it requires treatment with a high dose of inhaled corticosteroids plus a second controller and/or systemic corticosteroids to prevent it from becoming ''uncontrolled" or if it remains ''uncontrolled" despite this therapy. Severe asthma is a heterogeneous condition consisting of phenotypes such as eosinophilic asthma, which is characterized by sputum eosinophilia, associated with mild to moderate increase in blood eosinophil count, frequently adult-onset, and associated with chronic rhinosinusitis with nasal polyps in half of the cases...
2018: BioMed Research International
Daisuke Minami, Hiroe Kayatani, Ken Sato, Keiichi Fujiwara, Takuo Shibayama
A 64-year-old woman, who had presented with a 30-year history of refractory asthma, and been treated with anti-allergic drug therapy, inhaled corticosteroids, a long-acting beta-agonist, and a long-acting muscarinic antagonist. She had been characterized as an allergic, eosinophilic asthmatic. Although omalizumab was tried initially, it was found to be insufficient. We began treatment with benralizumab. The asthma symptom control and sinusitis were improved immediately. Benralizumab was effective for overlapping patient population following negative initial results with omalizumab...
January 2019: Respirology Case Reports
Diego Jose Maselli, Linda Rogers, Jay I Peters
There are now multiple monoclonal antibodies targeting different inflammatory pathways of severe asthma. Benralizumab is a recently approved monoclonal antibody indicated for the treatment of severe eosinophilic asthma by targeting a subunit of the IL-5 receptor. Treatment with benralizumab results in significant reductions of blood and tissue eosinophils. Early studies report that this therapy has an adequate safety profile, and this was confirmed in later trials. Phase III studies have shown that benralizumab is effective in reducing the rate of exacerbations and improving asthma symptoms and quality of life in patients with severe eosinophilic asthma...
2018: Therapeutics and Clinical Risk Management
Vivian C Agumadu, Kamleshun Ramphul, Stephanie G Mejias, Ruhi Sonaye, Shaheen Sombans, Petras Lohana
Asthma is a chronic respiratory condition that is characterized by reversible airflow obstruction. Interleukin-5 (IL-5) is involved in the pathophysiology of the disease and drugs targeting IL-5 have been studied for years as a possible treatment option for severe asthma. In this review, the authors searched PubMed for major drug therapies and clinical trials against IL-5. A total of 29 articles met the criteria for selection and were shortlisted; of these, 10 papers were on benralizumab, 14 on mepolizumab, and five on reslizumab...
August 27, 2018: Curēus
William W Busse, Eugene R Bleecker, J Mark FitzGerald, Gary T Ferguson, Peter Barker, Stephanie Sproule, Richard F Olsson, Ubaldo J Martin, Mitchell Goldman
BACKGROUND: Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that has been shown to safely reduce exacerbations and improve lung function for patients with asthma. We assessed the long-term safety and efficacy of benralizumab for patients with severe, uncontrolled eosinophilic asthma. METHODS: We conducted a randomised, double-blind, parallel-group, phase 3 extension study at 447 sites in 24 countries. Eligible patients had to have completed the SIROCCO or CALIMA trials and remained on subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W)...
November 8, 2018: Lancet Respiratory Medicine
Linda Zhu, Christina E Ciaccio, Thomas B Casale
In recent years there has been increasing recognition of varying asthma phenotypes that impact treatment response. This has led to the development of biological therapies targeting specific immune cells and cytokines in the inflammatory cascade. Currently, there are two primary asthma phenotypes, Type 2 hi and Type 2 lo, which are defined by eosinophilic and neutrophilic/pauci- granulocytic pattern of inflammation respectively. Most biologics focus on Type 2 hi asthma, including all four biologics approved for treatment of uncontrolled asthma in the United States - omalizumab, mepolizumab, reslizumab, and benralizumab...
2018: World Allergy Organization Journal
Rosalia Emma, Jaymin B Morjaria, Virginia Fuochi, Riccardo Polosa, Massimo Caruso
Asthma is a chronic inflammatory condition involving the airways with varying pathophysiological mechanisms, clinical symptoms and outcomes, generally controlled by conventional therapies including inhaled corticosteroids and long-acting β2 agonists. However, these therapies are unable to successfully control symptoms in about 5-10% of severe asthma patients. Atopic asthma, characterized by high immunoglobulin (Ig)E or eosinophilia, represents about 50% of asthmatic patients. Interleukin (IL)-5 is the main cytokine responsible of activation of eosinophils, hence therapeutic strategies have been investigated and developed for clinical use...
January 2018: Therapeutic Advances in Respiratory Disease
Arnaud Bourdin, Don Husereau, Nicolas Molinari, Sarowar Golam, Mohd Kashif Siddiqui, Leandro Lindner, Xiao Xu
Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons...
November 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
William W Busse
PURPOSE OF REVIEW: For patients with severe asthma, disease control is not achieved resulting in persistent morbidity and risks for exacerbations. The advent of biologics is providing a new form of treatment for many with severe asthma. RECENT FINDINGS: Four mAb biologics are approved for clinical use: omalizumab (anti-IgE) and three antieosinophilic interventions (mepolizumab, reslizumab, and benralizumab). These four biologics target components of the type 2-inflammatory pathway which is reflected by biomarkers: peripheral blood eosinophils and exhaled nitric oxide...
December 2018: Current Opinion in Allergy and Clinical Immunology
Thomas B Casale, Maud Pacou, Laura Mesana, Gaelle Farge, Shawn X Sun, Mario Castro
BACKGROUND: The interaction of IL-5 with its receptor on eosinophils increases the activation and maintenance of eosinophils; blocking this interaction reduces asthma symptoms in patients with the eosinophilic phenotype. Reslizumab, which binds to IL-5, and benralizumab, which targets the IL-5 receptor α subunit, have not been compared in head-to-head trials. OBJECTIVE: To indirectly compare reslizumab with benralizumab in similar patient populations using a network meta-analysis...
January 2019: Journal of Allergy and Clinical Immunology in Practice
Michel Aubier, Gabriel Thabut, Caroline Fabry-Vendrand
Background and objective: Benralizumab (Fasenra™ ) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting β2 -agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab. Patients and methods: This was a retrospective analysis of a prospective, noninterventional, observational study of patients in France enrolled in the Asthma and Bronchial Obstruction Cohort (COBRA)...
2018: Journal of Asthma and Allergy
Imran H Iftikhar, Mathew Schimmel, William Bender, Colin Swenson, David Amrol
BACKGROUND: Several new biologics have been studied in patients with eosinophilic asthma with varying degrees of response on clinical outcomes. No head-to-head trial has directly compared the efficacy of these drugs. OBJECTIVE: To synthesize data on the relative efficacy of benralizumab, dupilumab, lebrikizumab, mepolizumab, reslizumab, and tralokinumab using network meta-analysis. DATA SOURCES: We searched PubMed from inception to December 15th, 2017...
October 2018: Lung
Eugene R Bleecker, Michael E Wechsler, J Mark FitzGerald, Andrew Menzies-Gow, Yanping Wu, Ian Hirsch, Mitchell Goldman, Paul Newbold, James G Zangrilli
Benralizumab is an anti-eosinophilic monoclonal antibody that reduces exacerbations and improves lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation. We evaluated the impact of baseline factors on benralizumab efficacy for patients with severe asthma.This analysis used pooled data from the SIROCCO ( identifier NCT01928771) and CALIMA ( identifier NCT01914757) Phase III studies. Patients aged 12-75 years with severe, uncontrolled asthma receiving high-dosage inhaled corticosteroids plus long-acting β2 -agonists received benralizumab 30 mg subcutaneously every 8 weeks (Q8W, first three doses every 4 weeks (Q4W)), Q4W or placebo...
October 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
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