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REVIEW
Rini Patadia, Thomas B Casale, John Fowler, Shiven Patel, Juan Carlos Cardet
INTRODUCTION: Asthma encompasses a spectrum of phenotypes often categorized into two groups- type 2 high (T2 high) and type 2 low (T2 low). T2 high includes atopic and eosinophilic presentations whereas T2 low is non-atopic, non-eosinophilic, and oft associated with neutrophilic inflammation. Eosinophilic asthma is often driven by IgE, IL-4, IL-5, and IL-13 and TSLP. This can lead to eosinophilic inflammatory response in the airways which in turn can be used as target for treatment. AREAS COVERED: The article will focus on biologic therapy that is currently being used in eosinophilic asthma management in mainly the adult population including clinical trials and co-morbidities that can be treated using the same biologics...
April 15, 2024: Expert Opinion on Biological Therapy
#2
JOURNAL ARTICLE
Tham T Le, Benjamin Emmanuel, Rohit Katial, Trung N Tran, Justin Joseph Kwiatek, David S Cohen, Shoshana R Daniel, Yunhui Cao, Vivian H Shih, Maria Gil Melcón, Gilles Devouassoux, Girolamo Pelaia
PURPOSE: Real-world evidence of benralizumab effectiveness on nasal polyps (NP) and asthma outcomes in patients with severe eosinophilic asthma (SEA) and comorbid chronic rhinosinusitis with NP are limited. The objective of this study was to assess NP and asthma outcomes in benralizumab-treated patients with SEA and comorbid NP in a real-world setting. PATIENTS AND METHODS: RANS was a retrospective, multi-country observational study (ClinicalTrials.gov: NCT05180357) using medical chart reviews of adults with SEA and comorbid NP...
2024: Journal of Asthma and Allergy
#3
JOURNAL ARTICLE
Charlene Desaintjean, Kaïs Ahmad, Julie Traclet, Mathieu Gerfaud-Valentin, Cecile-Audrey Durel, Jean-Charles Glerant, Arnaud Hot, François Lestelle, Sabine Mainbourg, Mouhamad Nasser, Pascal Seve, Ségolène Turquier, Gilles Devouassoux, Vincent Cottin
INTRODUCTION: Asthma associated with eosinophilic granulomatosis with polyangiitis (EGPA) is often severe and corticosteroid-dependent, leading to significant morbidity. Mepolizumab and benralizumab are humanized monoclonal antibodies targeting interleukin 5 (IL-5) and its receptor, respectively. They have been shown to be effective in steroid-sparing in patients with severe eosinophilic asthma. OBJECTIVE: Our aim was to evaluate the efficacy and safety of mepolizumab and benralizumab prescribed for severe asthma in patients with EGPA under "real-world" conditions...
2024: Frontiers in Medicine
#4
JOURNAL ARTICLE
David J Jackson, Girolamo Pelaia, Benjamin Emmanuel, Trung N Tran, David Cohen, Vivian H Shih, Anat Shavit, Douglas Arbetter, Rohit Katial, Adrian Paul J Rabe, Esther Garcia Gil, Marisa Pardal, Javier Nuevo, Michael Watt, Silvia Boarino, Sheena Kayaniyil, Cláudia Chaves Loureiro, Alicia Padilla-Galo, Parameswaran Nair
BACKGROUND: Pivotal Phase 3 trials and real-world studies have demonstrated benralizumab's overall efficacy and safety in severe eosinophilic asthma (SEA). Additional large-cohort data are needed to confirm its real-world effectiveness in SEA according to previous biologic use and key baseline characteristics important for treatment selection. METHODS: XALOC-1 is a large, multinational, retrospective, observational, real-world study programme of benralizumab in adults with SEA...
April 4, 2024: European Respiratory Journal
#5
JOURNAL ARTICLE
Kefang Lai, Dejun Sun, Ranran Dai, Ronnie Samoro, Hae-Sim Park, Annika Åstrand, David Cohen, Maria Jison, Vivian H Shih, Viktoria Werkström, Yuhui Yao, Yajuan Zhang, Wenying Zheng, Nanshan Zhong, Albay Albert, Bo Jianping, Chen Bi, Chen Lijun, Chen Mei, Chen Min, Chen Ping, Chen Zhimin, Chian Chih-Feng, Cho You Sook, Fu Xiuhua, Gao Xiwen, Gu Wei, Han Wei, Han Zhihai, Hu Xi Wei, Huang Kewu, Huang Mao, Isidro Marie Grace Dawn, Jeong Inbeom, Jiang Luning, Jiang Mingyan, Jiang Shanping, Jin Meiling, Kang Jian, Kim Jin Woo, Kim Sang-Ha, Kuang Jiulong, Kuo Ping-Hung, Li Jie, Li Manxiang, Li Minjing, Li Ruoran, Li Wen, Li Xianhua, Li Yanming, Lim Seong Yong, Liu Chuanhe, Liu Chuntao, Liu Jing, Liu Xiaoxia, Lu Huiyu, Luo Zhuang, Ma Shengxi, Mao Liangping, Min Kyung Hoon, Mu Lin, Park Choon-Sik, Park Hae Sim, Park Hye-Kyung, Park Jung-Won, Perng Diahn-Warng, Samoro Ronnie, Shi Guochao, Sun Debin, Sun Dejun, Wang Chun-Hua, Wang Guangfa, Wang Limin, Wang Xuefen, Wang Yan, Wei Liping, Wu Haihong, Xiao Yi, Xiao Zuke, Xie Canmao, Xu Jin-Fu, Xu Xingxiang, Xu Xiyuan, Yan Jianping, Yang Hongzhong, Yoon Ho Joo, Yu Wencheng, Zhang Jin, Zhang Longju, Zhang Min, Zhang Wei, Zhao Jianping, Zhao Ziwen, Zhu Xiaoli, Zhu Yingqun
BACKGROUND: Benralizumab is indicated as add-on therapy in patients with uncontrolled, severe eosinophilic asthma; it has not yet been evaluated in a large Asian population with asthma in a clinical trial. OBJECTIVE: To evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia. METHODS: MIRACLE (NCT03186209) was a randomized, Phase 3 study in China, South Korea, and the Philippines. Patients aged 12-75 years with severe asthma receiving medium-to-high-dose inhaled corticosteroid/long-acting β2 -agonists, stratified (2:1) by baseline blood eosinophil count (bEOS) (≥300/μL; <300/μL), were randomized (1:1) to benralizumab 30 mg or placebo...
April 1, 2024: Respiratory Medicine
#6
JOURNAL ARTICLE
Paolo Cameli, Maria Aliani, Elena Altieri, Pietro Bracciale, Luisa Brussino, Maria Filomena Caiaffa, Giorgio Walter Canonica, Cristiano Caruso, Stefano Centanni, Maria D'Amato, Fausto De Michele, Stefano Del Giacco, Fabiano Di Marco, Girolamo Pelaia, Paola Rogliani, Micaela Romagnoli, Pietro Schino, Jan Walter Schroeder, Gianenrico Senna, Alessandra Vultaggio, Marco Benci, Silvia Boarino, Francesco Menzella
PURPOSE: Severe eosinophilic asthma (SEA) patients often present overlapping inflammatory features rendering them eligible for multiple biologic therapies; switching biologic treatment is a strategy adopted to optimize asthma control when patients show partial or no response to previous biologics. PATIENTS AND METHODS: ANANKE is a retrospective, multicenter Italian study (NCT04272463). Here, we outline the characteristics and long-term clinical outcomes in naïve-to-biologics and biologics-experienced patients treated with benralizumab for up to 96 weeks...
2024: Journal of Asthma and Allergy
#7
REVIEW
Felix Klimek, Christoph Bergmann, Jan Hagemann, Mandy Cuevas, Sven Becker, Oliver Pfaar, Ingrid Casper, Ludger Klimek
INTRODUCTION: Eosinophils play an important regulatory and immunomodulatory role in airway mucosa and have antiparasitic and antiviral properties as well as pro-inflammatory effects that may also cause persistence of inflammation with tissue remodeling. The number of eosinophils and the detection of specific mediators in biological samples from, e.g., blood, nasal secretions, and bronchial fluid can serve as biomarkers that reflect the underlying pathophysiology of certain diseases, predict treatment success, and detect therapy effects...
2024: Allergologie Select
#8
JOURNAL ARTICLE
Giada Sambugaro, Elena Brambilla, Giulia Costanzo, Vera Bonato, Andrea Giovanni Ledda, Stefano Del Giacco, Riccardo Scarpa, Marcello Rattazzi, Elisabetta Favero, Francesco Cinetto, Davide Firinu
This is a multicentric investigation involving two Italian centers that examined the clinical course of COVID-19 in patients receiving biological therapy targeting type 2 inflammation and those not receiving biologicals. Since the beginning of the COVID-19 pandemic, the management of respiratory and allergic disorders and the potential impact of biological therapy in the most severe forms has been a point of uncertainty. Our multicentric investigation aimed to compare the clinical course of COVID-19 and the impact of vaccination in an Italian cohort of patients with atopic disorders caused by a type 2 inflammation, such as eosinophilic asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis (AD), and chronic spontaneous urticaria (CSU)...
March 13, 2024: Life
#9
JOURNAL ARTICLE
Eva Martinez-Moragon, Eusebi Chiner, Alexandra Suliana Mogrovejo, Marta Palop Cervera, Inmaculada Lluch Tortajada, Ignacio Boira Enrique, Andrés Fernando Sánchez Vera
Patients with severe eosinophilic asthma experience high risk of exacerbations and reduced quality of life. Benralizumab, a monoclonal antibody binding to IL-5 receptor α subunit, is an approved drug for its treatment. The objective was to describe clinical remission after benralizumab prescription in routine clinical practice. Retrospective multicenter study with data from four hospitals in Valencian Community (Spain) with asthma units between 2019 and 2020. Data was gathered at baseline and after 12 months...
March 23, 2024: Journal of Asthma
#10
JOURNAL ARTICLE
Clare Bolton, Tim Harrison, Njira Lugogo, Anne Fuhlbrigge, Ian Hirsch, Thomas Bengtsson, Stefan Peterson, Martin Sidaway, Esther Garcia Gil, Malin Fagerås, Carla A Da Silva
BACKGROUND: CompEx Asthma, a composite end-point for asthma exacerbations, captures clinically relevant, diary-based acute worsening events (AWEs) (defined as deterioration in daily peak expiratory flow concurrent with deterioration in asthma symptoms and/or rescue therapy use) and severe exacerbations (SevEx) (defined by American Thoracic Society/European Respiratory Society guidelines). We hypothesised that CompEx and SevEx would show similar benralizumab treatment effects and correlations to blood eosinophil counts in patients with severe asthma...
March 2024: ERJ Open Research
#11
JOURNAL ARTICLE
H James Wedner, Takao Fujisawa, Theresa W Guilbert, Masanori Ikeda, Vinay Mehta, Jonathan S Tam, Pradeep B Lukka, Sara Asimus, Tomasz Durżyński, James Johnston, Wendy I White, Mihir Shah, Viktoria Werkström, Maria L Jison
BACKGROUND: Benralizumab is an anti-interleukin-5 receptor α monoclonal antibody approved as an add-on maintenance treatment for patients with uncontrolled severe asthma. Prior Phase 3 studies have evaluated benralizumab in patients aged ≥12 years with severe uncontrolled asthma. The TATE study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of benralizumab treatment in children. METHODS: TATE was an open-label, Phase 3 study of benralizumab in children aged 6-11 years from the United States and Japan (plus participants aged 12-14 years from Japan) with severe eosinophilic asthma...
March 2024: Pediatric Allergy and Immunology
#12
JOURNAL ARTICLE
Paola Maria Cutroneo, Elena Arzenton, Fabiana Furci, Fabio Scapini, Maria Bulzomì, Nicoletta Luxi, Marco Caminati, Gianenrico Senna, Ugo Moretti, Gianluca Trifirò
BACKGROUND: The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to August 2022, five biologics have been approved for the type 2 asthma phenotype: anti-IgE (omalizumab), anti-IL5 (mepolizumab, reslizumab, benralizumab), and anti-IL4 (dupilumab) monoclonal antibodies. These drugs are usually well tolerated, although long-term safety information is limited, and some adverse events have not yet been fully characterized. Spontaneous reporting systems represent the cornerstone for the detection of potential signals and evaluation of the real-world safety of all marketed drugs...
March 15, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#13
JOURNAL ARTICLE
Taha Al-Shaikhly, Matthew R Norris, Emily H Dennis, Guodong Liu, Timothy J Craig
BACKGROUND: Biologic modifiers targeting type-2 (T2) airway inflammation are effective in reducing asthma exacerbation, however real-world and comparative effectiveness studies remain limited. OBJECTIVE: to examine and compare the real-world impact of anti-T2 asthma biologics METHODS: In this retrospective new user cohort study, we used the MarketScan, a Commercial Claims and Encounters Database, to identify adult patients with asthma who were started on an anti-T2 biologic agent (anti-IL-5s, dupilumab or omalizumab)...
February 27, 2024: Journal of Allergy and Clinical Immunology in Practice
#14
Yoshiro Kai, Kentaro Suzuki, Ryosuke Kataoka, Ichiro Sato, Shinji Tamaki, Shigeo Muro
Severe asthma affects approximately 5%-10% of patients with asthma. Herein, we describe a case of non-type 2 asthma that progressively worsened over the years. An 80-year-old woman was diagnosed with asthma 11 years back. She experienced repeated exacerbations requiring treatment with systemic corticosteroid despite therapy with medications including high-dose inhaled corticosteroids/long-acting beta-agonists plus long-acting muscarinic antagonist. The patient presented with non-eosinophilic asthma. Therefore, the patient was initially treated with bronchial thermoplasty, which was effective for 1 year only...
March 2024: Respirology Case Reports
#15
JOURNAL ARTICLE
António Madeira Gerardo, Carolina da Silva Alves, Margarida Gomes, Cecília Pardal, Anna Sokolova, Hedi Liberato, Ana Mendes, Fernanda S Tonin, Filipa Duarte-Ramos, Carlos Lopes
INTRODUCTION: Add-on biological monoclonal antibodies such as benralizumab (anti-IL-5Ra) are recommended by international guidelines to reduce exacerbations in severe eosinophilic asthma (SEA). However, few studies have assessed the impact of these therapies on lung function-related outcomes. Our goal was to evaluate the effectiveness of benralizumab on lung function, including lung volumes and airway resistance, in SEA patients in Portugal. METHODS: This was a real-world, observational, prospective, multicentric study including adult patients diagnosed with SEA (January-June 2023)...
January 2024: Curēus
#16
JOURNAL ARTICLE
Maria Basagaña, Carlos Martínez-Rivera, Clara Padró, Ignasi Garcia-Olivé, Mimar Martínez-Colls, Juan Navarro, Laura Pardo, Paula Cruz, Gloria Cardona Peitx, Lídia Carabias, Albert Roger, Jorge Abad, Antoni Rosell
BACKGROUND: Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice...
December 2024: Annals of Medicine
#17
JOURNAL ARTICLE
Cecilia Rosso, Eugenio De Corso, Valerio Conti, Letizia Nitro, Alberto Maria Saibene, Elena Parazzini, Rocco Rinaldo, Sabrina De Pascalis, Flavio Arnone, Stefano Centanni, Claudio Montuori, Leandro Maria D'Auria, Giovanni Felisati, Carlotta Pipolo
PURPOSE: Nowadays, several efficacious biologic drugs are used for severe asthma with or without chronic rhinosinusitis with nasal polyps (CRSwNP). However, it has been observed that not all comorbid patients (asthma/CRSwNP) receiving biologic treatment for asthma experience satisfactory control of both conditions equally. METHODS: We selected 20 patients who had both severe asthma and comorbid CRSwNP under biological treatment with benralizumab, omalizumab or mepolizumab with adequate control of asthma but inadequate control of nasal symptoms...
February 12, 2024: European Archives of Oto-rhino-laryngology
#18
JOURNAL ARTICLE
Valentina D'Aiuto, Ilaria Mormile, Francescopaolo Granata, Antonio Romano, Francesca Della Casa, Caterina D'Onofrio, Valentina Marzio, Gabriele Mignogna, Luigi Califano, Amato de Paulis, Francesca Wanda Rossi
BACKGROUND: Eosinophilia can be influenced by multiple factors. This study aims to set a protocol for monitoring blood absolute eosinophil count (AEC) in patients with seasonal allergy affected by bronchial asthma (BA), allergic rhinitis (AR), or chronic rhinosinusitis with or without nasal polyposis (CRSw/sNP). METHODS: We planned a total of four annual blood samples to measure AEC in- and out-seasonal pollen exposure (i.e., one measurement every three months for one year)...
January 28, 2024: Journal of Clinical Medicine
#19
JOURNAL ARTICLE
Wen Li, Shi-Chao Tang, Lei Jin
BACKGROUND: We aimed to clarify comprehensively the safety profiles of anti-IL-5 drugs and pinpoint potential safety concerns that may arise in their post-marketing phase. METHODS: Two researchers conducted comprehensive searches of PubMed, EMBASE, Web of Science, and the Cochrane Library from inception to September 2022. Additionally, we investigated the FDA AE Reporting System for post-marketing adverse event (AE) reports related to anti-IL-5 drugs. The outcomes fulfilled the proportional reporting rate criteria and the Bayesian confidence propagation neural network...
February 3, 2024: BMC Pulmonary Medicine
#20
REVIEW
Riccardo Giossi, Arianna Pani, Jan Schroeder, Francesco Scaglione
INTRODUCTION: Benralizumab, mepolizumab, and reslizumab are novel monoclonal antibodies approved for asthma, targeting eosinophilic inflammation. Benralizumab is directed against IL-5 receptor (IL-5R), while mepolizumab and reslizumab are directed against IL-5. The three drugs cause a reduction in eosinophils, but benralizumab also causes a cytotoxic effect on eosinophils and basophils. Recently, it has been reported that suboptimal responders to benralizumab presented exacerbations associated with concomitant infections and sputum neutrophilia and the incidence of infections was greater in patients receiving benralizumab compared to mepolizumab and reslizumab...
January 15, 2024: Heliyon
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