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Benralizumab: for Eosinophilic asthma

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https://www.readbyqxmd.com/read/30077185/seasonal-variability-of-exacerbations-of-severe-uncontrolled-eosinophilic-asthma-and-clinical-benefits-of-benralizumab
#1
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 greater than or equal to 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...
August 4, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29972739/benralizumab-for-the-add-on-maintenance-treatment-of-patients-with-severe-asthma-aged-12-years-and-older-with-an-eosinophilic-phenotype
#2
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
https://www.readbyqxmd.com/read/29862274/benralizumab-from-the-basic-mechanism-of-action-to-the-potential-use-in-the-biological-therapy-of-severe-eosinophilic-asthma
#3
REVIEW
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
https://www.readbyqxmd.com/read/29780238/update-on-new-biologics-for-intractable-eosinophilic-asthma-impact-of-reslizumab
#4
REVIEW
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
https://www.readbyqxmd.com/read/29713354/severe-eosinophilic-asthma-in-primary-care-in-canada-a-longitudinal-study-of-the-clinical-burden-and-economic-impact-based-on-linked-electronic-medical-record-data
#5
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
https://www.readbyqxmd.com/read/29682504/targeting-the-interleukin-5-pathway-for-treatment-of-eosinophilic-conditions-other-than-asthma
#6
REVIEW
Florence Roufosse
Improved understanding of the contribution of eosinophils to various chronic inflammatory conditions, most notably allergic asthma, has encouraged development of monoclonal antibodies specifically targeting mediators and surface receptors involved in eosinophil expansion and activation. The pivotal role of interleukin-5 (IL-5) in eosinophil biology, its high specificity for this leukocyte subset, and its involvement in the majority of eosinophilic conditions make it a very enticing target for treatment of eosinophil-mediated disorders...
2018: Frontiers in Medicine
https://www.readbyqxmd.com/read/29670379/assessment-of-an-accessorized-pre-filled-syringe-for-home-administered-benralizumab-in-severe-asthma
#7
Gary T Ferguson, Adel H Mansur, Joshua S Jacobs, Jacques Hebert, Corbin Clawson, Wenli Tao, Yanping Wu, Mitchell Goldman
Background: Patients prefer at-home subcutaneous administration of biologics across different diseases, yet no biologic is approved for at-home use for severe, uncontrolled asthma. Objective: We assessed at-home functionality, reliability, and performance of an accessorized pre-filled syringe (APFS) for subcutaneous benralizumab administration, an anti-eosinophil monoclonal antibody indicated for add-on maintenance treatment of patients with severe eosinophilic asthma...
2018: Journal of Asthma and Allergy
https://www.readbyqxmd.com/read/29611207/immunological-and-hematological-effects-of-il-5-r%C3%AE-targeted-therapy-an-overview
#8
REVIEW
M Hassani, L Koenderman
IL-5 is an important cytokine for priming and survival of mature eosinophils, and for proliferation and maturation of their progenitors. Hence, IL-5(Rα) targeting will be increasingly used in diseases where eosinophils are the key immune effector cells such as eosinophilic asthma (EA), hyper eosinophilic syndrome (HES), eosinophilic esophagitis (EE) and eosinophilic granulomatosis with polyangitis (EGPA). Therefore, several neutralizing monoclonal antibodies directed against IL-5 (mepolizumab and reslizumab) and its receptor IL-5Rα (benralizumab) have found or will find their way to the clinic...
April 3, 2018: Allergy
https://www.readbyqxmd.com/read/29606855/benralizumab-in-the-treatment-of-severe-asthma-design-development-and-potential-place-in-therapy
#9
REVIEW
Corrado Pelaia, Alessandro Vatrella, Andrea Bruni, Rosa Terracciano, Girolamo Pelaia
Asthma is a widespread and heterogeneous inflammatory disease of the airways, which is characterized by several different phenotypes and endotypes. In particular, eosinophilic airway inflammation is a common pathologic trait of both allergic and nonallergic asthma. The key cytokine responsible for maturation, activation, recruitment, and survival of eosinophils is interleukin (IL)-5, which is mainly produced by T helper 2 (Th2) lymphocytes and group 2 innate lymphoid cells. Therefore, for uncontrolled patients with severe eosinophilic asthma, who are not fully responsive to corticosteroids, IL-5 represents a very important molecular target for add-on biological therapies...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29517082/benralizumab-for-the-treatment-of-asthma
#10
REVIEW
M G Matera, P Rogliani, L Calzetta, G W Canonica, M Cazzola
Benralizumab is a humanized monoclonal antibody directed at the a subunit of the interleukin-5 receptor (IL-5R) that is under clinical development. The binding of benralizumab with the alpha chain of IL-5R results in inhibition of hetero-oligomerization of alpha and beta subunits and thus no signal transduction occurs. Consequently, this inhibition prevents proliferation of eosinophils and basophils and the cascade of events following it. Several pivotal trials have documented that benralizumab reduces asthma exacerbation rates with a significant increase in time to the next exacerbation, statistically improves prebronchodilator forced expiratory volume in 1 second (FEV1) and disease-specific health-related quality of life, and is well tolerated in patients with severe asthma and blood eosinophil counts greater than or equal to 150 cells/mcL...
December 2017: Drugs of Today
https://www.readbyqxmd.com/read/29485975/benralizumab-fasenra-for-severe-eosinophilic-asthma
#11
(no author information available yet)
No abstract text is available yet for this article.
February 26, 2018: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/29464664/benralizumab-first-global-approval
#12
A Markham
Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)-a humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) monoclonal antibody-as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype...
March 2018: Drugs
https://www.readbyqxmd.com/read/29409951/benralizumab-efficacy-by-atopy-status-and-serum-immunoglobulin-e-for-patients-with-severe-uncontrolled-asthma
#13
Bradley E Chipps, Paul Newbold, Ian Hirsch, Frank Trudo, Mitchell Goldman
BACKGROUND: Patients with severe asthma can have eosinophilic inflammation and/or allergen sensitization. Benralizumab is an anti-eosinophilic monoclonal antibody indicated for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. OBJECTIVE: To investigate the efficacy of benralizumab by atopic status and serum immunoglobulin E (IgE) concentrations. METHODS: We analyzed pooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) phase III studies...
May 2018: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/29359607/benralizumab-an-anti-il-5-receptor-%C3%AE-monoclonal-antibody-in-the-treatment-of-asthma
#14
Maciej Kupczyk, Piotr Kuna
IL-5 is a key cytokine responsible for the maturation, recruitment and survival of eosinophils. The role of eosinophils in pathomechanisms of severe asthma and association of those cells with frequent exacerbations are well accepted. Novel biologic agents including anti-IL-5 antibodies (mepolizumab and reslizumab) as well as anti-IL-5 receptor α chain (benralizumab) have been developed. Benralizumab (Fasenra™) leads to reduced eosinophil counts in airway mucosa, blood, sputum and a clear inhibition of eosinophil differentiation and maturation in the bone marrow...
April 2018: Immunotherapy
https://www.readbyqxmd.com/read/29290671/pharmaceutical-approval-update
#15
Michele B Kaufman
Latanoprostene bunod ophthalmic solution (Vyzulta) for the reduction of intraocular pressure; letermovir (Prevymis) for prophylaxis of cytomegalovirus infection and disease after stem cell transplant; benralizumab (Fasenra) for the add-on maintenance treatment of severe asthma of an eosinophilic phenotype.
January 2018: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/29211545/efficacy-and-safety-of-benralizumab-for-eosinophilic-asthma-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#16
Bao-Ping Tian, Gen-Sheng Zhang, Jian Lou, Hong-Bin Zhou, Wei Cui
CONTEXT: Benralizumab is a humanized monoclonal antibody that targets the α chain of the IL-5 receptor (IL-5Rα) and is currently being assessed in clinical trials for asthma control. OBJECTIVE: Our systematic review and meta-analysis intends to evaluate the therapeutic efficacy and safety of benralizumab in patients with eosinophilic asthma. DATA SOURCES AND EXTRACTION: Literature searches of PubMed, Embase, and the Cochrane Library were performed to identify randomized controlled trials of benralizumab and clinic outcomes in asthmatics...
December 6, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/29128192/efficacy-and-safety-of-benralizumab-in-japanese-patients-with-severe-uncontrolled-eosinophilic-asthma
#17
Ken Ohta, Mitsuru Adachi, Yuji Tohda, Tadashi Kamei, Motokazu Kato, J Mark Fitzgerald, Masayuki Takanuma, Tadahiro Kakuno, Nobuyuki Imai, Yanping Wu, Magnus Aurivillius, Mitchell Goldman
BACKGROUND: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial. METHODS: CALIMA was a randomised, controlled trial of 1306 patients (aged 12-75 years; registered at ClinicalTrials.gov: NCT01914757) with severe asthma uncontrolled by medium- to high-dosage inhaled corticosteroids and long-acting β2 -agonists (ICS/LABA)...
April 2018: Allergology International: Official Journal of the Japanese Society of Allergology
https://www.readbyqxmd.com/read/29086236/efficacy-and-safety-of-benralizumab-in-patients-with-eosinophilic-asthma-a-meta-analysis-of-randomized-placebo-controlled-trials
#18
LETTER
Ting Liu, Faping Wang, Geng Wang, Hui Mao
Benralizumab is a monoclonal antibody that targets interleukin-5 receptor α to deplete blood eosinophils and improve the clinical outcomes of allergic asthma. We conducted a meta-analysis to evaluate the safety and efficacy of different doses of benralizumab in patients with eosinophilic asthma. All randomized controlled trials involving benralizumab treatment for patients with eosinophilic asthma, which were searched in PubMed, Embase, and the Cochrane Library published until January 2017, as well as the rate of asthmatic exacerbation, pulmonary functionality, asthma control, quality of life scores, and adverse events were included...
June 2018: Frontiers of Medicine
https://www.readbyqxmd.com/read/29059618/development-of-a-robust-reporter-gene-based-assay-for-the-bioactivity-determination-of-il-5-targeted-therapeutic-antibodies
#19
Zhihao Fu, Chuanfei Yu, Lan Wang, Kai Gao, Gangling Xu, Wenbo Wang, Junxia Cao, Junzhi Wang
Eosinophilic asthma is characterized by the eosinophilic inflammation with the allergen independent activation of Th2 lymphocytes. Since IL-5 plays an important role in the maturation, survival and migration of eosinophils, hence the pathogenesis of eosinophilic asthma, biotherapeutics targeting IL-5/IL-5Rα have been developed and/or marketed, including Mepolizumab, Reslizumab, and Benralizumab. Accurate determination of bioactivity is crucial for the safety and efficacy of therapeutic antibodies. The current mode of action (MOA) based method used in the quality control and stability tests for anti-IL-5 mAbs is anti-proliferation assay, which is tedious with long duration and high variation...
January 30, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29017221/-biologicals-in-the-treatment-of-bronchial-asthma
#20
I Haasler, C Taube
Biologicals are a therapeutic option for patients with severe asthma. Difficult asthma in patients with untreated comorbidities or persistent trigger factors is much more common than severe refractory asthma. Optimized medical treatment, adherence to medication, elimination of trigger factors and treatment of comorbidities are essential before escalating the therapy with a biological. A careful phenotyping of patient with severe asthma is necessary because all available biological are only effective in certain phenotypes of the disease...
October 2017: Pneumologie
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