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More recently&#44; it has been shown to be a part of the high TH2 group of potential biomarkers&#44; such as eNO and blood eosinophils&#44; in predecting future risk including recurrent exacerbations&#46; IgE and IgE receptors play a part in the pathophysiology of asthma by activating various effector cells even in non- allergic situations&#46; Very recently an epigenome association with total IgE was reported&#44; and methylated genes encoding for eosinophil products were connected in a reproducible way&#46; The results were confirmed by isolated eosinophils from patients with high eosinophilia and asthma&#46; This type of study will certainly point towards new types of mechanisms&#44; which will allow a more personalized way to treat asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Omalizumab has been shown in several well-performed studies to decrease the exacerbation rate in severe uncontrolled allergic asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> It has been used with success to treat mild asthma and allergic rhinitis and to prevent seasonal exacerbations in patients with a broad range of severity&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Randomized control studies are helpful to demonstrate the efficacy and safety of new drugs&#46; They are the bottom line of marketing in westernized countries&#46; They sustain the different guidelines&#44; but even though most of the recommendations are based on randomized control studies&#44; most of the patients with severe asthma are not qualified to enter RCP studies&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Therefore large pragmatic trials with real life conditions are currently more popular&#46; These trials will try to demonstrate efficiency and include a large numbers of patients&#46; They will enroll patients with less strict criteria&#44; closer a real clinical situation and allow a longitudinal follow-up with pertinent outcomes&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">In this issue of the journal&#44; taking advantage of the EXperience study&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> our Portuguese colleagues have considered 62 patients from their own country to demonstrate an overall 60&#37; satisfaction with the treatment&#44; with a fair control of asthma including daily symptoms and exacerbations&#46; The treatment improves health related quality of life but has little impact on lung function&#46; This study describes an interesting observation and confirms the larger study from Grimaldi Bensoussa et al&#44; reporting the real improvement seen in the initial Innovate study&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> The number of severe exacerbations and the need for oral corticosteroid upsurges were significantly decreased in this real life study of omalizumab treated patients as compared to the reference arm&#46; We can postulate that omalizumab is a well-established treatment in Europe for severe asthma&#46; It is advocated by the GINA guidelines and the ATS&#47;ERS task force on severe asthma&#44; however as a specific biotherapy it requires more investigation&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> It would be worth knowing if we can confirm its efficacy in non-allergic severe asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> We are all fighting to improve antecipation of the response to the intervention&#46; At present&#44; we need specific biomarkers with an impact on future risk&#46; Last of all&#44; it is important to assess the potential for these interventions to go along with asthma remission&#44; but recent studies are not very encouraging&#46; Omalizumab is the first efficient and safe biotherapy for severe asthma with the potential to be used in this disease&#46; We should continue to question how it works and to report efficiency data from large real life cohort studies&#46;</p></span>"
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Editorial
Omalizumab: a treatment for severe asthma in real life?
Anaïs Briquet, Pascal Chanez
Corresponding author
pascal.chanez@univ-amu.fr

Corresponding author.
Département des Maladies Respiratoires, AP-HM, INSERM CNRS U 1067, UMR7733, Aix Marseille Université, Marseille, France
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    "titulo" => "Omalizumab&#58; a treatment for severe asthma in real life&#63;"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 2015&#44; asthma remains an important health problem&#46; It is costly&#58; first as a chronic disorder it represents a significant burden for the patients and their relatives&#59; secondly due to management of disease including controller medications and what is required for acute exacerbations i&#46;e&#46;&#58; hospitalizations and days off work Overall&#44; while mortality has certainly decreased&#44; most of our current treatments are still primarily symptom based and do not alter with the natural history of the disease&#46; Meanwhile&#44; severe asthma remains a challenge&#44; as most patients with this type of asthma remain uncontrolled despite a real diagnosis&#44; a fair compliance and an important need of existing therapies with known side effects&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Total IgE has been linked to asthma in epidemiological studies and was considered to be associated with an allergic phenotype of the disease&#46; More recently&#44; it has been shown to be a part of the high TH2 group of potential biomarkers&#44; such as eNO and blood eosinophils&#44; in predecting future risk including recurrent exacerbations&#46; IgE and IgE receptors play a part in the pathophysiology of asthma by activating various effector cells even in non- allergic situations&#46; Very recently an epigenome association with total IgE was reported&#44; and methylated genes encoding for eosinophil products were connected in a reproducible way&#46; The results were confirmed by isolated eosinophils from patients with high eosinophilia and asthma&#46; This type of study will certainly point towards new types of mechanisms&#44; which will allow a more personalized way to treat asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Omalizumab has been shown in several well-performed studies to decrease the exacerbation rate in severe uncontrolled allergic asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> It has been used with success to treat mild asthma and allergic rhinitis and to prevent seasonal exacerbations in patients with a broad range of severity&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Randomized control studies are helpful to demonstrate the efficacy and safety of new drugs&#46; They are the bottom line of marketing in westernized countries&#46; They sustain the different guidelines&#44; but even though most of the recommendations are based on randomized control studies&#44; most of the patients with severe asthma are not qualified to enter RCP studies&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Therefore large pragmatic trials with real life conditions are currently more popular&#46; These trials will try to demonstrate efficiency and include a large numbers of patients&#46; They will enroll patients with less strict criteria&#44; closer a real clinical situation and allow a longitudinal follow-up with pertinent outcomes&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">In this issue of the journal&#44; taking advantage of the EXperience study&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> our Portuguese colleagues have considered 62 patients from their own country to demonstrate an overall 60&#37; satisfaction with the treatment&#44; with a fair control of asthma including daily symptoms and exacerbations&#46; The treatment improves health related quality of life but has little impact on lung function&#46; This study describes an interesting observation and confirms the larger study from Grimaldi Bensoussa et al&#44; reporting the real improvement seen in the initial Innovate study&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> The number of severe exacerbations and the need for oral corticosteroid upsurges were significantly decreased in this real life study of omalizumab treated patients as compared to the reference arm&#46; We can postulate that omalizumab is a well-established treatment in Europe for severe asthma&#46; It is advocated by the GINA guidelines and the ATS&#47;ERS task force on severe asthma&#44; however as a specific biotherapy it requires more investigation&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> It would be worth knowing if we can confirm its efficacy in non-allergic severe asthma&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> We are all fighting to improve antecipation of the response to the intervention&#46; At present&#44; we need specific biomarkers with an impact on future risk&#46; Last of all&#44; it is important to assess the potential for these interventions to go along with asthma remission&#44; but recent studies are not very encouraging&#46; Omalizumab is the first efficient and safe biotherapy for severe asthma with the potential to be used in this disease&#46; We should continue to question how it works and to report efficiency data from large real life cohort studies&#46;</p></span>"
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Pulmonology

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