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Benralizumab: for Eosinophilic asthma

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...
September 11, 2018: 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
Andrea Matucci, Alessandra Vultaggio, Romano Danesi
BACKGROUND: Monoclonal antibodies (mAbs) approved for use as add-on therapy in patients with severe asthma target the underlying pathogenesis of asthma. MAIN BODY: Omalizumab binds immunoglobulin E (IgE), thereby inhibiting its interaction with the high-affinity IgE receptor and reducing the quantity of free IgE available to trigger the allergic cascade. Anti-interleukin (IL)-5 mAbs mepolizumab, benralizumab and reslizumab block the interaction between IL-5 and its receptor on eosinophils, thus targeting the eosinophilic pathway in asthma...
August 16, 2018: Respiratory Research
Lawrence DuBuske, Paul Newbold, Yanping Wu, Frank Trudo
BACKGROUND: Benralizumab is a humanized, afucosylated, monoclonal antibody that targets interleukin-5 receptor alpha and induces direct, rapid, and nearly complete depletion of eosinophils via enhanced antibody-dependent cell-mediated cytotoxicity. In the United States, benralizumab is indicated for add-on maintenance treatment of patients ≥12 years old with severe asthma and an eosinophilic phenotype. OBJECTIVE: This study evaluated the effect of benralizumab treatment on seasonal asthma exacerbation rates for patients with severe, uncontrolled asthma...
September 4, 2018: Allergy and Asthma Proceedings:
Khalid Al Efraij, J Mark FitzGerald
Asthma is an airway disease characterized by airway inflammation. It is associated with significant morbidity, mortality, and costs to the health-care system and society. Eosinophils and interleukin-5 (IL-5) play a key role in the inflammatory response in T-helper 2-high asthma. IL-5 is pivotal for eosinophil development, maturation, and survival in tissues. Asthma severity has been related to both airway and peripheral blood eosinophilia. Areas covered: In this review, we present the pharmacokinetics and pharmacodynamics of benralizumab in addition to efficacy and safety data in the treatment of severe eosinophilic asthma...
July 2018: Expert Review of Clinical Pharmacology
Corrado Pelaia, Cecilia Calabrese, Alessandro Vatrella, Maria Teresa Busceti, Eugenio Garofalo, Nicola Lombardo, Rosa Terracciano, Girolamo Pelaia
Asthma is a very frequent chronic airway disease that includes many different clinical phenotypes and inflammatory patterns. In particular, eosinophilic bronchial inflammation is often associated with allergic as well as nonallergic asthma. The most important cytokine involved in the induction, maintenance, and amplification of airway eosinophilia in asthma is interleukin-5 (IL-5), released by both T helper 2 (Th2) lymphocytes and group 2 innate lymphoid cells (ILC2). Hence, IL-5 and its receptor are suitable targets for selective biologic drugs which can play a key role in add-on treatment of severe eosinophilic asthma refractory to corticosteroids...
2018: BioMed Research International
Jagdeep Sahota, Douglas S Robinson
A small percentage of patients with asthma have uncontrolled symptoms and frequent exacerbations, despite treatment with inhaled corticosteroids and other agents. It has become clear that different subtypes of this severe, treatment-resistant group exist due to different mechanisms of the disease. All such patients require detailed assessment in specialist centers to characterize the disease and assess treatment adherence. Recently, monoclonal antibodies have become available, which target specific pathways that may contribute to persistent inflammation and asthma exacerbations...
2018: Drug Design, Development and Therapy
Don Husereau, Jason Goodfield, Richard Leigh, Richard Borrelli, Michel Cloutier, Alain Gendron
Background: Stratification of patients with severe asthma by blood eosinophil counts predicts responders to anti-interleukin (IL)-5 (mepolizumab and reslizumab) and anti-IL-5 receptor α (benralizumab) therapies. This study characterized patients with severe asthma who could qualify for these biologics in a primary care setting. Methods: We retrospectively selected patients from July 1, 2010, to June 30, 2014, using a linked electronic medical records (EMR) database (IMS Evidence 360 EMR Canada) for > 950,000 patients in primary care in Ontario, Canada...
2018: Allergy, Asthma, and Clinical Immunology
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