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Il 13 antibody severe asthma

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https://www.readbyqxmd.com/read/29725983/liberty-asthma-quest-phase-3-randomized-double-blind-placebo-controlled-parallel-group-study-to-evaluate-dupilumab-efficacy-safety-in-patients-with-uncontrolled-moderate-to-severe-asthma
#1
William W Busse, Jorge F Maspero, Klaus F Rabe, Alberto Papi, Sally E Wenzel, Linda B Ford, Ian D Pavord, Bingzhi Zhang, Heribert Staudinger, Gianluca Pirozzi, Nikhil Amin, Bolanle Akinlade, Laurent Eckert, Jingdong Chao, Neil M H Graham, Ariel Teper
INTRODUCTION: Dupilumab, a fully human anti-IL-4Rα monoclonal antibody, inhibits signaling of both interleukin (IL)-4 and IL-13, which are key drivers of type 2-mediated inflammation. Dupilumab is approved in the EU, USA, and other countries for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. Following positive phase 2 results in asthma, the phase 3 Liberty Asthma QUEST trial was initiated to provide further evidence for dupilumab efficacy and safety in patients with uncontrolled, moderate-to-severe asthma...
May 3, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29536781/tralokinumab-for-the-treatment-of-severe-uncontrolled-asthma-the-atmosphere-clinical-development-program
#2
Reynold A Panettieri, Millie Wang, Martin Braddock, Karin Bowen, Gene Colice
Tralokinumab, a fully human IgG4 monoclonal antibody, specifically neutralizes IL-13. The ATMOSPHERE clinical development program comprised four randomized, placebo-controlled clinical trials and an open-label study that aimed to assess the efficacy and safety of tralokinumab for the treatment of severe, uncontrolled asthma. The two pivotal trials (STRATOS 1 and STRATOS 2; NCT02161757 and NCT02194699) evaluated the efficacy and safety of tralokinumab, with STRATOS 1 identifying a subgroup most likely to demonstrate enhanced response to treatment...
March 1, 2018: Immunotherapy
https://www.readbyqxmd.com/read/29416367/profile-of-dupilumab-and-its-potential-in-the-treatment-of-inadequately-controlled-moderate-to-severe-atopic-dermatitis
#3
REVIEW
Olabola Awosika, Lori Kim, Momina Mazhar, Monica Rengifo-Pardo, Alison Ehrlich
Atopic dermatitis (AD) is a common inflammatory skin disorder that manifests as eczematous lesions, often associated with allergic rhinitis and asthma. Historically, moderate-to-severe disease has been managed with systemic immunosuppression, such as oral corticosteroids, which result in relapse and limiting side effects. Due to recent advancements in the identification of interleukin (IL)-4 and IL-13 as key mediators in AD, new biological agents have been developed for treatment. Dupilumab is a recently approved monoclonal antibody that targets the alpha subunit of the IL-4 receptor and, thus, downregulates activity of IL-4 and IL-13...
2018: Clinical, Cosmetic and Investigational Dermatology
https://www.readbyqxmd.com/read/29413515/baseline-serum-cxcl10-and-il-12-levels-may-predict-severe-asthmatics-responsiveness-to-omalizumab
#4
Maho Suzukawa, Hisako Matsumoto, Nobuharu Ohshima, Hiroyuki Tashimo, Isao Asari, Tomoko Tajiri, Akio Niimi, Hiroyuki Nagase, Hirotoshi Matsui, Nobuyuki Kobayashi, Shunsuke Shoji, Ken Ohta
BACKGROUND: Omalizumab, a humanized anti-IgE monoclonal antibody, is the first molecularly targeted drug for severe asthmatics. However, responses to omalizumab vary widely among patients. OBJECTIVES: This study aimed to assess the potential of baseline serum cytokine levels as predictors of responsiveness to omalizumab. METHODS: Thirty-one patients with severe, persistent asthma were enrolled in this study and administered omalizumab for at least 1 year...
January 2018: Respiratory Medicine
https://www.readbyqxmd.com/read/29355679/efficacy-and-safety-of-dupilumab-in-perennial-allergic-rhinitis-and-comorbid-asthma
#5
Steven F Weinstein, Rohit Katial, Shyamalie Jayawardena, Gianluca Pirozzi, Heribert Staudinger, Laurent Eckert, Vijay N Joish, Nikhil Amin, Jaman Maroni, Paul Rowe, Neil M H Graham, Ariel Teper
BACKGROUND: Dupilumab, an anti-IL-4 receptor α mAb, inhibits IL-4/IL-13 signaling, key drivers of type 2/TH 2 immune diseases (eg, atopic/allergic disease). In a pivotal, phase 2b study (NCT01854047), dupilumab reduced severe exacerbations, improved lung function and quality of life, and was generally well tolerated in patients with uncontrolled persistent asthma despite using medium-to-high-dose inhaled corticosteroids plus long-acting β2-agonists. OBJECTIVE: To examine dupilumab's effect on the 22-item Sino-Nasal Outcome Test (SNOT-22) total score and its allergic rhinitis (AR)-associated items in asthma patients with comorbid perennial allergic rhinitis (PAR)...
January 31, 2018: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29334288/targeted-anti-il-13-therapies-in-asthma-current-data-and-future-perspectives
#6
REVIEW
Polyxeni Ntontsi, Evgenia Papathanassiou, Stelios Loukides, Petros Bakakos, Georgios Hillas
The identification of patients with severe asthma who will benefit from a personalized management approach remains an unmet need. Interleukin-13 (IL-13) is a cytokine possessing a significant role in asthma pathogenesis and progression of disease. Humanised monoclonal antibodies against IL-13 and IL-13 and IL-4 receptors are mainly proposed as add-on therapy in patients with TH 2-high inflammation with uncontrolled asthma despite maximum therapy. Areas covered: The role of IL-13 in airway inflammation in severe asthma, the targeted anti-IL-13 therapies and biomarkers that predict response to anti-IL-13 treatment are discussed...
February 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29318959/novel-biological-therapies-in-severe-asthma-targeting-the-right-trait
#7
Gilda Varricchi, Giancarlo Marone, Giuseppe Spadaro, Michele Russo, Francescopaolo Granata, Arturo Genovese, Gianni Marone
Asthma is a heterogeneous disease characterized by chronic airway inflammation that results in a wide spectrum of clinical manifestations. Patients with severe asthma represent a substantial share of consumption of healthcare resources and hospitalization. Moreover, these patients are at risk of increased morbidity and mortality. Recently, several phenotypes and endotypes of asthma have been identified. The identification of specific subtypes of asthma is fundamental for optimizing the clinical benefit of novel treatments...
January 9, 2018: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/29248521/monoclonal-antibodies-against-interleukin-13-and-interleukin-31ra-in-development-for-atopic-dermatitis
#8
Carsten R Hamann, Jacob P Thyssen
The interleukin 13 (IL-13) and IL-31 cytokines and inflammatory pathways have been identified as important for the pathophysiology of atopic dermatitis (AD). Monoclonal antibodies against IL-13 have been studied for the treatment of asthma since 2011. More recently, 2 phase 2 trials have been completed with these antibodies in AD treatment. In both trials, significant reductions of Eczema Area and Severity Index scores were seen. IL-31 is thought to play a role transmitting itch sensation to the central nervous system, and blocking IL-31 activity reduces itch in patients with AD...
March 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29211545/efficacy-and-safety-of-benralizumab-for-eosinophilic-asthma-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#9
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/29108767/biologics-in-the-treatment-of-severe-asthma
#10
REVIEW
S Quirce, E Phillips-Angles, J Domínguez-Ortega, P Barranco
Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids and with a second controller drug to prevent it from becoming uncontrolled or which remains uncontrolled despite this therapy. Patients with uncontrolled severe asthma require additional treatment options as add-on therapy, including biologics. Biologic therapies in asthma are designed to block key immune regulators, such as IgE, or certain pro-inflammatory cytokines, e.g. interleukin (IL)-5, IL-4, IL-13 or IL-17...
December 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/29068539/eosinophil-persistence-in-vivo-and-sustained-viability-ex-vivo-in-response-to-respiratory-challenge-with-fungal-allergens
#11
W E Geslewitz, C M Percopo, H F Rosenberg
BACKGROUND: Eosinophils are immunomodulatory leucocytes that contribute to the pathogenesis of Th2-driven asthma and allergic lung diseases. OBJECTIVE: Our goal was to identify unique properties of eosinophils recruited to the lungs and airways of mice in response to challenge with asthma-associated fungal allergens. METHODS: Mice were challenged intranasally on days 0, 3 and 6 with a filtrate of Alternaria alternata. Recruited eosinophils were enumerated in bronchoalveolar lavage fluid...
January 2018: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28990423/dupilumab-for-the-treatment-of-asthma
#12
REVIEW
Corrado Pelaia, Alessandro Vatrella, Luca Gallelli, Rosa Terracciano, Paolo Navalesi, Rosario Maselli, Girolamo Pelaia
Dupilumab is a fully human IgG4 monoclonal antibody directed against the α subunit of the interleukin (IL)-4 receptor (IL-4Rα). Since the activation of IL-4Rα is utilized by both IL-4 and IL-13 to mediate their pathophysiological effects, dupilumab behaves as a dual antagonist of these two sister cytokines, which blocks IL-4/IL-13-dependent signal transduction. Areas covered: Herein, the authors review the cellular and molecular pathways activated by IL-4 and IL-13, which are relevant to asthma pathobiology...
December 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28979129/dupilumab-in-the-management-of-moderate-to-severe-asthma-the-data-so-far
#13
REVIEW
Pilar Barranco, Elsa Phillips-Angles, Javier Dominguez-Ortega, Santiago Quirce
Severe asthma constitutes illness in a relatively small proportion of all patients with asthma, but it is a major public health problem - with considerable effect on morbidity, mortality, as well as a high burden on health care resources. Regardless of effective treatments being widely available and the existence of treatment guidelines, a large population of severe asthma cases remain uncontrolled. Achieving and maintaining asthma control in this group of patients is, therefore, of utmost importance. The recognition of distinct inflammatory phenotypes within this population has driven the development of targeted biological therapies - particularly, selective targeted monoclonal antibodies (mAbs)...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28948572/overlapping-effects-of-new-monoclonal-antibodies-for-severe-asthma
#14
REVIEW
Christian Domingo
Among the monoclonal antibodies (mAbs) developed for severe asthma treatment, three have already been marketed. Omalizumab was the first, more than 10 years ago; today, mepolizumab and reslizumab are also available in the European Union and the US. Omalizumab blocks free immunoglobulin E (IgE), mepolizumab and reslizumab block an interleukin (IL-5). In the near future, dupilumab and benralizumab are expected to emerge as two new alternatives. Benralizumab blocks the receptor for IL-5 (IL5-Rα) and has a direct cytotoxic effect on eosinophils, and dupilumab blocks the α-unit of the heterodimeric receptor for IL-4 and IL-13 (IL-4Rα); as a result, dupilumab can block both IL-4 and IL-13...
October 2017: Drugs
https://www.readbyqxmd.com/read/28910970/antibody-therapy-for-the-management-of-severe-asthma-with-eosinophilic-inflammation
#15
Ken Ohta, Hiroyuki Nagase, Maho Suzukawa, Shin Ohta
One of the characteristic features of asthma is chronic airway inflammation typically with eosinophil infiltration. Most asthmatics can be treated successfully with conventional treatment appropriate for their severity, but in some severe cases, asthma cannot be well controlled even with thorough treatment and this condition is known as 'refractory asthma'. To overcome severe refractory asthma, a new therapeutic strategy with biologics has been developed based on the knowledge of molecular mechanisms of airway inflammation in asthma, induced by the condition of high Th2-type responses and activation of eosinophils as well as allergic reactions...
July 1, 2017: International Immunology
https://www.readbyqxmd.com/read/28888244/new-and-anticipated-therapies-for-severe-asthma
#16
Stephen P Peters, William W Busse
Asthma is frequently undertreated, resulting in a relatively high prevalence of patients with uncontrolled disease, characterized by the presence of symptoms and risk of adverse outcomes. Patients with uncontrolled asthma have a higher risk of morbidity and mortality, underscoring the importance of identifying uncontrolled disease and modifying management plans to improve control. Several assessment tools exist to evaluate control with various cutoff points and measures, but these tools do not reliably correlate with physiological measures and should be considered a supplement to physiological tests...
September 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28843617/model-based-clinical-pharmacology-profiling-and-exposure-response-relationships-of-the-efficacy-and-biomarker-of-lebrikizumab-in-patients-with-moderate-to-severe-asthma
#17
Rui Zhu, Yanan Zheng, Nathanael L Dirks, Shweta Vadhavkar, Jin Yan Jin, Kun Peng, Cecile T J Holweg, Julie Olsson, John G Matthews, Wendy S Putnam
Lebrikizumab is a humanized monoclonal antibody that binds to interleukin-13 and has been evaluated as a treatment for moderate-to-severe asthma. Objectives of this work were to characterize lebrikizumab pharmacokinetics (PK), identify influential covariates, and graphically explore exposure-response relationships in moderate-to-severe asthmatics. Pooled PK data from 11 studies were used in the population PK model development. Full covariate modeling was used to evaluate the impact of pre-specified covariates...
October 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28830530/prenatal-tobacco-smoke-exposure-predisposes-offspring-mice-to-exacerbated-allergic-airway-inflammation-associated-with-altered-innate-effector-function
#18
Maria Ferrini, Sophia Carvalho, Yoon Hee Cho, Britten Postma, Lucas Miranda Marques, Kent Pinkerton, Kevan Roberts, Zeina Jaffar
BACKGROUND: Epidemiological studies suggest that prenatal and early life environmental exposures have adverse effects on pulmonary function and are important contributors in the development of childhood asthma and allergic disease. The mechanism by which environmental tobacco smoke (ETS) exposure in utero promotes the development of allergic asthma remains unclear. In this study, we investigated the immunological consequences of prenatal exposure to ETS in order to understand events responsible for the development or exacerbation of allergic asthma...
August 22, 2017: Particle and Fibre Toxicology
https://www.readbyqxmd.com/read/28758192/dose-exposure-response-relationship-of-the-investigational-anti-interleukin-13-monoclonal-antibody-tralokinumab-in-patients-with-severe-uncontrolled-asthma
#19
Paul G Baverel, Nicholas White, Paolo Vicini, Mats O Karlsson, Balaji Agoram
Interleukin (IL)-13 is involved in the pathogenesis of some types of asthma. Tralokinumab is a human immunoglobulin G4 monoclonal antibody that specifically binds to IL-13. Two placebo-controlled phase II studies (phase IIa, NCT00873860 and phase IIb, NCT01402986) have been conducted in which tralokinumab was administered subcutaneously. This investigation aimed to characterize tralokinumab's dose-exposure-response (forced expiratory volume in 1 s (FEV1 )) relationship in patients with asthma and to predict the most appropriate dose for phase III...
May 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28751233/sputum-autoantibodies-in-patients-with-severe-eosinophilic-asthma
#20
Manali Mukherjee, David C Bulir, Katherine Radford, Melanie Kjarsgaard, Chynna Margaret Huang, Elizabeth A Jacobsen, Sergei I Ochkur, Ana Catuneanu, Hanah Lamothe-Kipnes, James Mahony, James J Lee, Paige Lacy, Parameswaran K Nair
BACKGROUND: The persistence of eosinophils in sputum despite high doses of corticosteroids indicates disease severity in asthmatic patients. Chronic inflamed airways can lose tolerance over time to immunogenic entities released on frequent eosinophil degranulation, which further contributes to disease severity and necessitates an increase in maintenance corticosteroids. OBJECTIVES: We sought to investigate the possibility of a polyclonal autoimmune event in the airways of asthmatic patients and to identify associated clinical and molecular characteristics...
July 24, 2017: Journal of Allergy and Clinical Immunology
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