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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Asthma is a complex&#44; heterogeneous disease characterized by chronic airway inflammation&#44; episodic respiratory symptoms&#44; and associated with variable expiratory airflow limitation&#46; The prevalence of asthma is increasing&#44; and is estimated to affect 358 million people worldwide in the recent Global Burden of Disease report&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">1</span></a> 5&#37;&#8211;10&#37; are said to have severe asthma&#44; defined as asthma that requires treatment with high dose inhaled corticosteroids and a second controller for the previous year&#44; and&#47;or systemic corticosteroids for &#8805;50&#37; of the previous year to prevent it from becoming uncontrolled or that remains uncontrolled despite this therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">2</span></a> This subset of patients has poorer lung function&#44; quality of life&#44; and recurrent exacerbations&#59; is at increased risk of significant morbidity and mortality&#44; and exerts a substantial burden on healthcare resources&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Understanding the heterogeneity of the airway inflammation in severe asthma is of particular importance to predict future risk of exacerbations and response to therapy&#46; The presence of eosinophilic airway inflammation is associated with poorer asthma control and increased risk of exacerbations&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">3</span></a> and is a good predictor of a favorable response to corticosteroids&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">4</span></a> Beyond corticosteroids&#44; monoclonal antibodies targeting Type 2 &#40;T2&#41; immunity and consequent eosinophilic inflammation in severe asthma has been developed&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The first monoclonal antibody for asthma was omalizumab&#44; a humanized monoclonal antibody against IgE used since 2003 in adults&#44; adolescents and children over 6 years of age with moderate to severe persistent allergic asthma inadequately controlled with standard therapy&#46; It improved asthma symptoms and health-related quality of life&#46; It also reduced exacerbations and daily inhaled corticosteroid dose&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> Response to omalizumab was better in asthmatics with increased biomarkers of T2 immunity and eosinophilic inflammation including serum periostin&#44; blood eosinophil count and fraction of exhaled nitric oxide&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Anti-interleukin-5 &#40;IL-5&#41; monoclonal antibodies are the second class of biological therapy for severe eosinophilic asthma&#46; IL-5 cytokine plays an important role in the maturation and activation of eosinophils&#46; Mepolizumab is a humanized monoclonal antibody that binds to IL-5&#44; preventing it from binding to IL-5 receptors&#46; The first large phase IIb&#47;III trial &#40;DREAM study&#41; showed that mepolizumab at a range of doses significantly reduced severe exacerbation rate in subjects with recurrent exacerbations and evidence of eosinophilic inflammation&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">7</span></a> The results were also replicated in another phase III trial using a lower intravenous Mepolizumab dose of 75<span class="elsevierStyleHsp" style=""></span>mg and a subcutaneous dose of 100<span class="elsevierStyleHsp" style=""></span>mg&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> Mepolizumab has also been shown to have steroid-sparing effects by significantly reducing daily systemic corticosteroid use compared to placebo&#44; while maintaining its exacerbation reduction effect&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">9</span></a> The efficacy of mepolizumab appeared to be more pronounced in subjects with higher baseline blood eosinophil levels and more frequent exacerbations&#44; with no benefit in exacerbation reduction in those with a blood eosinophil count &#60;150<span class="elsevierStyleHsp" style=""></span>cells&#47;&#956;L&#46; On the strength of these positive trial results&#44; it has since been licensed for use in severe eosinophilic asthma&#46; Reslizumab&#44; another monoclonal antibody targeting IL-5&#44; was also recently licensed for use in severe eosinophilic &#40;&#8805;400 blood eosinophils&#47;&#956;L&#41; asthma following phase III trials demonstrating significant improvement in forced expiratory volume in 1 second &#40;FEV1&#41;&#44; asthma control scores&#44; asthma-related quality of life and frequency of asthma exacerbations&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">10&#44;11</span></a> However&#44; when used across a broad range of blood eosinophil counts&#44; reslizumab had no effect on lung function and asthma control&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">12</span></a> Benralizumab differs from mepolizumab and reslizumab as it acts on the alpha chain of the IL-5 receptor causing eosinophil apoptosis&#46; Two recent phase III trials in subjects with inadequately controlled asthma&#44; frequent exacerbations and elevated blood eosinophil count showed significant reduction of annual asthma exacerbation rate compared to placebo&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">13&#44;14</span></a> It also significantly improved FEV1&#44; Asthma Control Questionnaire &#40;ACQ&#41; and Asthma Quality of Life Questionnaire &#40;AQLQ&#41; scores in those receiving the treatment every 8 weeks&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Inhibiting other T2-cytokines such as IL-13 neutralization &#40;Lebrikizumab and Tralokinumab&#41; or the alpha chain of the IL-4 receptor which attenuates both IL-4 and IL-13 signaling &#40;Dupilumab&#41; are attractive targets&#46; None of these strategies have demonstrated an effect on reducing eosinophilic inflammation&#44; but benefits for these approaches are greater in those with upregulated T2-immunity and eosinophilic inflammation&#46; Recent phase III studies for Lebrikizumab failed to demonstrate consistent benefit for reduction in asthma exacerbations<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">15</span></a> and phase III studies for Tralokinumab are ongoing &#40;<a href="ctgov:NCT02194699">NCT02194699</a> and <a href="ctgov:NCT02161757">NCT02161757</a>&#41;&#46; Findings from a phase IIb study of Dupilumab were more encouraging&#44; showing reductions in exacerbation frequency and improvements in symptoms in all comers with greatest response in those with eosinophilic inflammation&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">16</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">In addition to biological therapy&#44; small molecule inhibitors have shown promising results in severe asthma&#46; Prostaglandin D<span class="elsevierStyleInf">2</span> &#40;PGD<span class="elsevierStyleInf">2</span>&#41; is a prostanoid mainly produced by mast cells&#44; which binds and activates G protein-coupled receptors&#58; D prostanoid 1&#44; thromboxane A<span class="elsevierStyleInf">2</span> receptor and D prostanoid 2 &#40;DP<span class="elsevierStyleInf">2</span>&#41;&#46; DP<span class="elsevierStyleInf">2</span> is also known as chemoattractant receptor-homologous molecule on T helper Type 2 cells &#40;CRTh<span class="elsevierStyleInf">2</span>&#41;&#44; selectively expressed on Th2 cells&#44; eosinophils&#44; basophils&#44; Type 2 innate lymphoid cells &#40;ILC2s&#41;&#44; epithelial cells and airway smooth muscle&#46; In a recent single-center randomized placebo-controlled study of patients with moderate-to-severe asthma and sputum eosinophilia &#40;&#8805;2&#37;&#41;&#44; fevipiprant &#40;a potent and highly selective DP<span class="elsevierStyleInf">2</span> antagonist&#41; showed significant reduction in eosinophilic inflammation in both sputum and bronchial submucosa compared with placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">17</span></a> There was significant effect on AQLQ score&#44; post bronchodilator FEV1 and functional residual capacity in all patients&#44; and the ACQ-7 score in a pre-defined subgroup of patients who had uncontrolled asthma&#46; The effect on asthma exacerbations is now being evaluated in phase III clinical trials&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Thus&#44; the armamentarium for the treatment of severe eosinophilic asthma is expanding&#46; Future research is needed to give further insight into which patients are most likely to have the greatest response to which treatment&#44; and to better define both response and failure to respond to these new therapies&#46; This might require head-to-head pragmatic real life trials of licensed therapies&#46; Notwithstanding this limitation&#44; the prospect of new and effective treatments is now within our grasp&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interest</span><p id="par0040" class="elsevierStylePara elsevierViewall">PHP declares to have no conflict of interest directly or indirectly related to the manuscript contents&#46; CEB has received consultancy fees and or grants paid to his Institution from AZ&#47;Medimmune&#44; GSK&#44; Roche&#47;Genentech&#44; BI&#44; Chiesi&#44; Teva&#44; Sanofi&#47;Regeneron&#44; Vectura&#44; Theravance&#44; Novartis&#44; Gilead and Pfizer&#46;</p></span></span>"
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Editorial
Emerging Therapies in Severe Eosinophilic Asthma
Nuevas terapias para el asma eosinofílica grave
Pee Hwee Panga, Christopher E. Brightlingb,
Corresponding author
ceb17@le.ac.uk

Corresponding author.
a Department of Respiratory and Critical Care Medicine, Tan Tock Seng Hospital, Singapore
b Institute for Lung Health, NIHR Respiratory Biomedical Research Unit, Department of Infection, Immunity & Inflammation, University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, UK
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Asthma is a complex&#44; heterogeneous disease characterized by chronic airway inflammation&#44; episodic respiratory symptoms&#44; and associated with variable expiratory airflow limitation&#46; The prevalence of asthma is increasing&#44; and is estimated to affect 358 million people worldwide in the recent Global Burden of Disease report&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">1</span></a> 5&#37;&#8211;10&#37; are said to have severe asthma&#44; defined as asthma that requires treatment with high dose inhaled corticosteroids and a second controller for the previous year&#44; and&#47;or systemic corticosteroids for &#8805;50&#37; of the previous year to prevent it from becoming uncontrolled or that remains uncontrolled despite this therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">2</span></a> This subset of patients has poorer lung function&#44; quality of life&#44; and recurrent exacerbations&#59; is at increased risk of significant morbidity and mortality&#44; and exerts a substantial burden on healthcare resources&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Understanding the heterogeneity of the airway inflammation in severe asthma is of particular importance to predict future risk of exacerbations and response to therapy&#46; The presence of eosinophilic airway inflammation is associated with poorer asthma control and increased risk of exacerbations&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">3</span></a> and is a good predictor of a favorable response to corticosteroids&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">4</span></a> Beyond corticosteroids&#44; monoclonal antibodies targeting Type 2 &#40;T2&#41; immunity and consequent eosinophilic inflammation in severe asthma has been developed&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The first monoclonal antibody for asthma was omalizumab&#44; a humanized monoclonal antibody against IgE used since 2003 in adults&#44; adolescents and children over 6 years of age with moderate to severe persistent allergic asthma inadequately controlled with standard therapy&#46; It improved asthma symptoms and health-related quality of life&#46; It also reduced exacerbations and daily inhaled corticosteroid dose&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> Response to omalizumab was better in asthmatics with increased biomarkers of T2 immunity and eosinophilic inflammation including serum periostin&#44; blood eosinophil count and fraction of exhaled nitric oxide&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Anti-interleukin-5 &#40;IL-5&#41; monoclonal antibodies are the second class of biological therapy for severe eosinophilic asthma&#46; IL-5 cytokine plays an important role in the maturation and activation of eosinophils&#46; Mepolizumab is a humanized monoclonal antibody that binds to IL-5&#44; preventing it from binding to IL-5 receptors&#46; The first large phase IIb&#47;III trial &#40;DREAM study&#41; showed that mepolizumab at a range of doses significantly reduced severe exacerbation rate in subjects with recurrent exacerbations and evidence of eosinophilic inflammation&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">7</span></a> The results were also replicated in another phase III trial using a lower intravenous Mepolizumab dose of 75<span class="elsevierStyleHsp" style=""></span>mg and a subcutaneous dose of 100<span class="elsevierStyleHsp" style=""></span>mg&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> Mepolizumab has also been shown to have steroid-sparing effects by significantly reducing daily systemic corticosteroid use compared to placebo&#44; while maintaining its exacerbation reduction effect&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">9</span></a> The efficacy of mepolizumab appeared to be more pronounced in subjects with higher baseline blood eosinophil levels and more frequent exacerbations&#44; with no benefit in exacerbation reduction in those with a blood eosinophil count &#60;150<span class="elsevierStyleHsp" style=""></span>cells&#47;&#956;L&#46; On the strength of these positive trial results&#44; it has since been licensed for use in severe eosinophilic asthma&#46; Reslizumab&#44; another monoclonal antibody targeting IL-5&#44; was also recently licensed for use in severe eosinophilic &#40;&#8805;400 blood eosinophils&#47;&#956;L&#41; asthma following phase III trials demonstrating significant improvement in forced expiratory volume in 1 second &#40;FEV1&#41;&#44; asthma control scores&#44; asthma-related quality of life and frequency of asthma exacerbations&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">10&#44;11</span></a> However&#44; when used across a broad range of blood eosinophil counts&#44; reslizumab had no effect on lung function and asthma control&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">12</span></a> Benralizumab differs from mepolizumab and reslizumab as it acts on the alpha chain of the IL-5 receptor causing eosinophil apoptosis&#46; Two recent phase III trials in subjects with inadequately controlled asthma&#44; frequent exacerbations and elevated blood eosinophil count showed significant reduction of annual asthma exacerbation rate compared to placebo&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">13&#44;14</span></a> It also significantly improved FEV1&#44; Asthma Control Questionnaire &#40;ACQ&#41; and Asthma Quality of Life Questionnaire &#40;AQLQ&#41; scores in those receiving the treatment every 8 weeks&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Inhibiting other T2-cytokines such as IL-13 neutralization &#40;Lebrikizumab and Tralokinumab&#41; or the alpha chain of the IL-4 receptor which attenuates both IL-4 and IL-13 signaling &#40;Dupilumab&#41; are attractive targets&#46; None of these strategies have demonstrated an effect on reducing eosinophilic inflammation&#44; but benefits for these approaches are greater in those with upregulated T2-immunity and eosinophilic inflammation&#46; Recent phase III studies for Lebrikizumab failed to demonstrate consistent benefit for reduction in asthma exacerbations<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">15</span></a> and phase III studies for Tralokinumab are ongoing &#40;<a href="ctgov:NCT02194699">NCT02194699</a> and <a href="ctgov:NCT02161757">NCT02161757</a>&#41;&#46; Findings from a phase IIb study of Dupilumab were more encouraging&#44; showing reductions in exacerbation frequency and improvements in symptoms in all comers with greatest response in those with eosinophilic inflammation&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">16</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">In addition to biological therapy&#44; small molecule inhibitors have shown promising results in severe asthma&#46; Prostaglandin D<span class="elsevierStyleInf">2</span> &#40;PGD<span class="elsevierStyleInf">2</span>&#41; is a prostanoid mainly produced by mast cells&#44; which binds and activates G protein-coupled receptors&#58; D prostanoid 1&#44; thromboxane A<span class="elsevierStyleInf">2</span> receptor and D prostanoid 2 &#40;DP<span class="elsevierStyleInf">2</span>&#41;&#46; DP<span class="elsevierStyleInf">2</span> is also known as chemoattractant receptor-homologous molecule on T helper Type 2 cells &#40;CRTh<span class="elsevierStyleInf">2</span>&#41;&#44; selectively expressed on Th2 cells&#44; eosinophils&#44; basophils&#44; Type 2 innate lymphoid cells &#40;ILC2s&#41;&#44; epithelial cells and airway smooth muscle&#46; In a recent single-center randomized placebo-controlled study of patients with moderate-to-severe asthma and sputum eosinophilia &#40;&#8805;2&#37;&#41;&#44; fevipiprant &#40;a potent and highly selective DP<span class="elsevierStyleInf">2</span> antagonist&#41; showed significant reduction in eosinophilic inflammation in both sputum and bronchial submucosa compared with placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">17</span></a> There was significant effect on AQLQ score&#44; post bronchodilator FEV1 and functional residual capacity in all patients&#44; and the ACQ-7 score in a pre-defined subgroup of patients who had uncontrolled asthma&#46; The effect on asthma exacerbations is now being evaluated in phase III clinical trials&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Thus&#44; the armamentarium for the treatment of severe eosinophilic asthma is expanding&#46; Future research is needed to give further insight into which patients are most likely to have the greatest response to which treatment&#44; and to better define both response and failure to respond to these new therapies&#46; This might require head-to-head pragmatic real life trials of licensed therapies&#46; Notwithstanding this limitation&#44; the prospect of new and effective treatments is now within our grasp&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interest</span><p id="par0040" class="elsevierStylePara elsevierViewall">PHP declares to have no conflict of interest directly or indirectly related to the manuscript contents&#46; CEB has received consultancy fees and or grants paid to his Institution from AZ&#47;Medimmune&#44; GSK&#44; Roche&#47;Genentech&#44; BI&#44; Chiesi&#44; Teva&#44; Sanofi&#47;Regeneron&#44; Vectura&#44; Theravance&#44; Novartis&#44; Gilead and Pfizer&#46;</p></span></span>"
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ISSN: 15792129
Original language: English
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