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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The determination of various biomarkers in patients with severe uncontrolled asthma is currently considered indispensable&#46; This information helps determine the bronchial inflammatory profile&#44; define the asthma phenotype&#44; and guide the possible therapeutic options&#46;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">1&#8211;3</span></a> Over the past 2 decades&#44; significant advances in immunology and molecular biology have led to the development of biological therapy targeted at some of these biomarkers in the treatment of severe uncontrolled asthma&#46; A recent monograph on severe asthma published by the European Respiratory Society<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a> reviewed the definitions accepted by the Biomarker Working Group of the Food and Drug Administration and the National Health Institute&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">5</span></a> These guidelines describe a biomarker as a measurable characteristic that is an indicator of normal biological processes&#44; pathogenic processes&#44; or responses to exposure or intervention&#44; including therapeutic interventions&#46; The authors propose 7 possible categories for biomarkers&#58; diagnosis&#44; monitoring&#44; response&#44; prognosis&#44; susceptibility&#47;risk&#44; safety&#44; and prediction&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">5</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The history of biomarkers in asthma is relatively recent&#44; dating back 20 years to when Wenzel et al&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">6</span></a> observed in 1999 that patients with higher blood eosinophil counts had more severe asthma than those with lower concentrations&#46; These eosinophilic patients also showed greater basal membrane thicknesses in bronchial biopsies&#44; suggesting that they had undergone an intense process of airway remodeling&#46; About 10 years later&#44; Woodruff et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a> reported that a group of asthma patients presented a very intense inflammatory process characterized by increased eosinophils in blood and in bronchoalveolar lavage&#44; raised periostin levels&#44; and a thicker basal membrane in bronchial biopsies&#44; all associated with a more intense response to inhaled corticosteroids&#46; This group of patients was defined as Th2-high phenotype&#44; based on the belief that such inflammation was basically mediated by type 2 helper T cells&#46; This Th2-high phenotype is defined mainly by the presence of eosinophils in blood and sputum&#44; high levels of fractional exhaled nitric oxide&#44; and raised serum levels of periostin and immunoglobulin E &#40;IgE&#41;&#46; Th2-high patients express higher levels of interleukin &#40;IL&#41;4&#44; IL5 and IL13 in bronchial biopsies&#44; and show higher bronchial hyperreactivity and higher mucin gene expression in the airways&#46; In other words&#44; this Th2-high phenotype encompasses several of the phenotypes described in the literature&#44; such as severe allergic asthma and non-allergic eosinophilic asthma&#46; This inflammation has recently been renamed T2 inflammation&#44; since other immune cells involved as mediators such as type 2 innate lymphoid cells have been observed&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> Patients who did not express this marked inflammation were practically indistinguishable from healthy subjects and were assigned the Th2-low phenotype&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Several biomarkers have been described in the T2-high severe uncontrolled asthma phenotype&#44; and while the list is extensive&#44; biomarkers that currently have an impact on clinical practice are IgE&#44; eosinophils in blood and&#47;or sputum&#44; and fractional exhaled nitric oxide&#44; although the diagnostic&#47;therapeutic role of the latter remains controversial in the clinical practice guidelines&#46;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">1&#44;2</span></a> Firstly&#44; IgE is one of the most widely used biomarkers in allergic asthma&#46; IgE blockade with omalizumab produced excellent results after more than 10 years of use as additional treatment in patients with allergic severe uncontrolled asthma in a real world setting&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> The importance of IgE beyond allergic asthma has been established in a series of studies&#44; one of the findings of which was that IgE binding to high affinity receptors can induce intracellular signaling responsible for the production of cytokines &#40;IL4&#44; IL6&#44; IL13&#44; etc&#46;&#41; and stimulate mast cell activation without the need to bind with allergens&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Eosinophils&#44; for their part&#44; have become one of the most studied cells in asthma in recent years&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> This research has had a great impact on modern biological treatment&#44; since the T2-high eosinophilic phenotype involves the increased expression of certain cytokines&#44; such as IL4&#44; IL33 and IL5&#44; which are among the main therapeutic targets at present&#46; Today 3 different biological treatments that act on IL5 are available&#58; mepolizumab<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a> and reslizumab&#44;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> which act by directly blocking IL5&#44; and benralizumab&#44;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> which acts on the IL5 receptor &#945;&#46; These biologics have recently been approved for the treatment of severe eosinophilic asthma&#44; after they were seen to be highly effective in pivotal studies&#46; Other biologics are also available for the treatment of severe uncontrolled asthma&#44; some of which are still in the experimental phase&#44; such as dupilumab&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> which blocks the IL4&#47;IL13 receptor and will shortly be marketed in Spain&#46; With respect to the T2-low phenotype&#44; neutrophils in sputum and some interleukins such as IL17 and IL8 have been proposed as biomarkers&#44; but so far none have been associated with any targeted biological treatment and their usefulness in clinical practice is limited&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Numerous biomarkers are being evaluated with the aim of selecting the most suitable treatment for each patient with severe uncontrolled asthma&#46; These include volatile organic compounds&#44; the determination of pH in exhaled breath condensate&#44; IL6 and other cytokines&#44; using proteomics&#44; metabolomics and transcriptomics which could help determine the various inflammatory pathways that may be involved&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">15&#44;16</span></a> One of the most important endeavors at the moment is to define clinically useful&#47;therapeutic biomarkers in patients with non-T2 or T2-low phenotype&#44; as the mechanisms underlying this inflammation remain unclear and poorly understood&#44; and no biologic targeted at this patient phenotype is currently available&#46; Biomarkers play an essential role in asthma today&#44; and must be determined in all patients with uncontrolled severe asthma correct diagnostic and therapeutic decision-making&#46; Furthermore&#44; new biomarkers are needed to help not only decide between different therapeutic options&#44; but also to predict response to these treatments&#44; so all possible mechanisms involved in inflammation and the pathophysiology of uncontrolled severe asthma should be further investigated&#44; especially in the T2-low phenotype&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interests</span><p id="par0030" class="elsevierStylePara elsevierViewall">Ebymar Arismendi has received honoraria as a speaker&#44; scientific advisor&#44; and clinical trial investigator from &#40;in alphabetical order&#41;&#58; AstraZeneca&#44; Bial&#44; Chiesi&#44; GlaxoSmithKline&#44; Novartis and Teva&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">C&#233;sar Picado Vall&#233;s has received honoraria as a speaker&#44; scientific advisor&#44; and clinical trial investigator from Novartis&#46;</p></span></span>"
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Editorial
Current Role of Biomarkers in Severe Uncontrolled Asthma
Papel de los biomarcadores en el asma grave no controlada en la actualidad
Ebymar Arismendia,b,
Corresponding author
earismen@clinic.cat

Corresponding author.
, César Picado Vallésa,b,c
a Servicio de Neumología, Hospital Clínic de Barcelona, Barcelona, Spain
b CIBER Enfermedades Respiratorias (CibeRes), Madrid, Spain
c IDIBAPS-Universitat de Barcelona, Barcelona, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The determination of various biomarkers in patients with severe uncontrolled asthma is currently considered indispensable&#46; This information helps determine the bronchial inflammatory profile&#44; define the asthma phenotype&#44; and guide the possible therapeutic options&#46;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">1&#8211;3</span></a> Over the past 2 decades&#44; significant advances in immunology and molecular biology have led to the development of biological therapy targeted at some of these biomarkers in the treatment of severe uncontrolled asthma&#46; A recent monograph on severe asthma published by the European Respiratory Society<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a> reviewed the definitions accepted by the Biomarker Working Group of the Food and Drug Administration and the National Health Institute&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">5</span></a> These guidelines describe a biomarker as a measurable characteristic that is an indicator of normal biological processes&#44; pathogenic processes&#44; or responses to exposure or intervention&#44; including therapeutic interventions&#46; The authors propose 7 possible categories for biomarkers&#58; diagnosis&#44; monitoring&#44; response&#44; prognosis&#44; susceptibility&#47;risk&#44; safety&#44; and prediction&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">5</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The history of biomarkers in asthma is relatively recent&#44; dating back 20 years to when Wenzel et al&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">6</span></a> observed in 1999 that patients with higher blood eosinophil counts had more severe asthma than those with lower concentrations&#46; These eosinophilic patients also showed greater basal membrane thicknesses in bronchial biopsies&#44; suggesting that they had undergone an intense process of airway remodeling&#46; About 10 years later&#44; Woodruff et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a> reported that a group of asthma patients presented a very intense inflammatory process characterized by increased eosinophils in blood and in bronchoalveolar lavage&#44; raised periostin levels&#44; and a thicker basal membrane in bronchial biopsies&#44; all associated with a more intense response to inhaled corticosteroids&#46; This group of patients was defined as Th2-high phenotype&#44; based on the belief that such inflammation was basically mediated by type 2 helper T cells&#46; This Th2-high phenotype is defined mainly by the presence of eosinophils in blood and sputum&#44; high levels of fractional exhaled nitric oxide&#44; and raised serum levels of periostin and immunoglobulin E &#40;IgE&#41;&#46; Th2-high patients express higher levels of interleukin &#40;IL&#41;4&#44; IL5 and IL13 in bronchial biopsies&#44; and show higher bronchial hyperreactivity and higher mucin gene expression in the airways&#46; In other words&#44; this Th2-high phenotype encompasses several of the phenotypes described in the literature&#44; such as severe allergic asthma and non-allergic eosinophilic asthma&#46; This inflammation has recently been renamed T2 inflammation&#44; since other immune cells involved as mediators such as type 2 innate lymphoid cells have been observed&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> Patients who did not express this marked inflammation were practically indistinguishable from healthy subjects and were assigned the Th2-low phenotype&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Several biomarkers have been described in the T2-high severe uncontrolled asthma phenotype&#44; and while the list is extensive&#44; biomarkers that currently have an impact on clinical practice are IgE&#44; eosinophils in blood and&#47;or sputum&#44; and fractional exhaled nitric oxide&#44; although the diagnostic&#47;therapeutic role of the latter remains controversial in the clinical practice guidelines&#46;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">1&#44;2</span></a> Firstly&#44; IgE is one of the most widely used biomarkers in allergic asthma&#46; IgE blockade with omalizumab produced excellent results after more than 10 years of use as additional treatment in patients with allergic severe uncontrolled asthma in a real world setting&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> The importance of IgE beyond allergic asthma has been established in a series of studies&#44; one of the findings of which was that IgE binding to high affinity receptors can induce intracellular signaling responsible for the production of cytokines &#40;IL4&#44; IL6&#44; IL13&#44; etc&#46;&#41; and stimulate mast cell activation without the need to bind with allergens&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Eosinophils&#44; for their part&#44; have become one of the most studied cells in asthma in recent years&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> This research has had a great impact on modern biological treatment&#44; since the T2-high eosinophilic phenotype involves the increased expression of certain cytokines&#44; such as IL4&#44; IL33 and IL5&#44; which are among the main therapeutic targets at present&#46; Today 3 different biological treatments that act on IL5 are available&#58; mepolizumab<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a> and reslizumab&#44;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> which act by directly blocking IL5&#44; and benralizumab&#44;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> which acts on the IL5 receptor &#945;&#46; These biologics have recently been approved for the treatment of severe eosinophilic asthma&#44; after they were seen to be highly effective in pivotal studies&#46; Other biologics are also available for the treatment of severe uncontrolled asthma&#44; some of which are still in the experimental phase&#44; such as dupilumab&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a> which blocks the IL4&#47;IL13 receptor and will shortly be marketed in Spain&#46; With respect to the T2-low phenotype&#44; neutrophils in sputum and some interleukins such as IL17 and IL8 have been proposed as biomarkers&#44; but so far none have been associated with any targeted biological treatment and their usefulness in clinical practice is limited&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Numerous biomarkers are being evaluated with the aim of selecting the most suitable treatment for each patient with severe uncontrolled asthma&#46; These include volatile organic compounds&#44; the determination of pH in exhaled breath condensate&#44; IL6 and other cytokines&#44; using proteomics&#44; metabolomics and transcriptomics which could help determine the various inflammatory pathways that may be involved&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">15&#44;16</span></a> One of the most important endeavors at the moment is to define clinically useful&#47;therapeutic biomarkers in patients with non-T2 or T2-low phenotype&#44; as the mechanisms underlying this inflammation remain unclear and poorly understood&#44; and no biologic targeted at this patient phenotype is currently available&#46; Biomarkers play an essential role in asthma today&#44; and must be determined in all patients with uncontrolled severe asthma correct diagnostic and therapeutic decision-making&#46; Furthermore&#44; new biomarkers are needed to help not only decide between different therapeutic options&#44; but also to predict response to these treatments&#44; so all possible mechanisms involved in inflammation and the pathophysiology of uncontrolled severe asthma should be further investigated&#44; especially in the T2-low phenotype&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interests</span><p id="par0030" class="elsevierStylePara elsevierViewall">Ebymar Arismendi has received honoraria as a speaker&#44; scientific advisor&#44; and clinical trial investigator from &#40;in alphabetical order&#41;&#58; AstraZeneca&#44; Bial&#44; Chiesi&#44; GlaxoSmithKline&#44; Novartis and Teva&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">C&#233;sar Picado Vall&#233;s has received honoraria as a speaker&#44; scientific advisor&#44; and clinical trial investigator from Novartis&#46;</p></span></span>"
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Article information
ISSN: 15792129
Original language: English
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