Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience
Abstract Background Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. Objectives Medical registries were used to evalu...
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| Veröffentlicht in: | Pulmonary pharmacology & therapeutics 2012-02, Vol.25 (1), p.77-82 |
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| creator | Tzortzaki, Eleni G Georgiou, Andreas Kampas, Dimitrios Lemessios, Marinos Markatos, Miltiadis Adamidi, Tonia Samara, Katerina Skoula, Georgia Damianaki, Aggeliki Schiza, Sophia Tzanakis, Nikos Siafakas, Nikolaos M |
| description | Abstract Background Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. Objectives Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. Methods Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). Results Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p |
| doi_str_mv | 10.1016/j.pupt.2011.11.004 |
| format | Article |
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Objectives Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. Methods Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). Results Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (−65% p = 0.0002 at 1 year, and −70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months ( p = 0.017), 1 year ( p = 0.029) and 4 years ( p = 0.014) of omalizumab treatment. Conclusions This long-term “real-life” study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the “real-life” practice.</description><identifier>ISSN: 1094-5539</identifier><identifier>EISSN: 1522-9629</identifier><identifier>DOI: 10.1016/j.pupt.2011.11.004</identifier><identifier>PMID: 22155001</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Administration, Inhalation ; Adrenal Cortex Hormones - administration & dosage ; Adrenal Cortex Hormones - therapeutic use ; Aged ; Allergy ; Anti-Asthmatic Agents - administration & dosage ; Anti-Asthmatic Agents - adverse effects ; Anti-Asthmatic Agents - therapeutic use ; Anti-IgE ; Antibodies, Anti-Idiotypic - administration & dosage ; Antibodies, Anti-Idiotypic - adverse effects ; Antibodies, Anti-Idiotypic - therapeutic use ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Asthma ; Asthma - complications ; Asthma - drug therapy ; Asthma - etiology ; Cohort Studies ; Data Collection ; Drug Therapy, Combination ; Efficacy ; Female ; Forced Expiratory Volume ; Humans ; Hypersensitivity - complications ; Immunoglobulin E ; Long-Term Care ; Male ; Medical Education ; Mediterranean Region ; Middle Aged ; Omalizumab ; Pulmonary/Respiratory ; Severe asthma ; Spirometry ; Therapy ; Treatment Outcome ; Vital Capacity</subject><ispartof>Pulmonary pharmacology & therapeutics, 2012-02, Vol.25 (1), p.77-82</ispartof><rights>Elsevier Ltd</rights><rights>2011 Elsevier Ltd</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-f76adf962524f4e3260a365d017a2d58a59dca9f30a00b2d9a361be27dcb1d063</citedby><cites>FETCH-LOGICAL-c410t-f76adf962524f4e3260a365d017a2d58a59dca9f30a00b2d9a361be27dcb1d063</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.pupt.2011.11.004$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22155001$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tzortzaki, Eleni G</creatorcontrib><creatorcontrib>Georgiou, Andreas</creatorcontrib><creatorcontrib>Kampas, Dimitrios</creatorcontrib><creatorcontrib>Lemessios, Marinos</creatorcontrib><creatorcontrib>Markatos, Miltiadis</creatorcontrib><creatorcontrib>Adamidi, Tonia</creatorcontrib><creatorcontrib>Samara, Katerina</creatorcontrib><creatorcontrib>Skoula, Georgia</creatorcontrib><creatorcontrib>Damianaki, Aggeliki</creatorcontrib><creatorcontrib>Schiza, Sophia</creatorcontrib><creatorcontrib>Tzanakis, Nikos</creatorcontrib><creatorcontrib>Siafakas, Nikolaos M</creatorcontrib><title>Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience</title><title>Pulmonary pharmacology & therapeutics</title><addtitle>Pulm Pharmacol Ther</addtitle><description>Abstract Background Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. Objectives Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. Methods Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). Results Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (−65% p = 0.0002 at 1 year, and −70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months ( p = 0.017), 1 year ( p = 0.029) and 4 years ( p = 0.014) of omalizumab treatment. Conclusions This long-term “real-life” study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the “real-life” practice.</description><subject>Administration, Inhalation</subject><subject>Adrenal Cortex Hormones - administration & dosage</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Aged</subject><subject>Allergy</subject><subject>Anti-Asthmatic Agents - administration & dosage</subject><subject>Anti-Asthmatic Agents - adverse effects</subject><subject>Anti-Asthmatic Agents - therapeutic use</subject><subject>Anti-IgE</subject><subject>Antibodies, Anti-Idiotypic - administration & dosage</subject><subject>Antibodies, Anti-Idiotypic - adverse effects</subject><subject>Antibodies, Anti-Idiotypic - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Asthma</subject><subject>Asthma - complications</subject><subject>Asthma - drug therapy</subject><subject>Asthma - etiology</subject><subject>Cohort Studies</subject><subject>Data Collection</subject><subject>Drug Therapy, Combination</subject><subject>Efficacy</subject><subject>Female</subject><subject>Forced Expiratory Volume</subject><subject>Humans</subject><subject>Hypersensitivity - complications</subject><subject>Immunoglobulin E</subject><subject>Long-Term Care</subject><subject>Male</subject><subject>Medical Education</subject><subject>Mediterranean Region</subject><subject>Middle Aged</subject><subject>Omalizumab</subject><subject>Pulmonary/Respiratory</subject><subject>Severe asthma</subject><subject>Spirometry</subject><subject>Therapy</subject><subject>Treatment Outcome</subject><subject>Vital Capacity</subject><issn>1094-5539</issn><issn>1522-9629</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxiMEon_gBTgg3zhlGTtxghFCqqoWKm3FoeVsOfak68Vxgu1UlFMfBF6uT4LTLRx6QBrJI_ubbzy_KYpXFFYUaPN2u5rmKa0YULrKAVA_KfYpZ6wUDRNPcw6iLjmvxF5xEOMWANq64s-LPcYo5wB0v0jr0V-VCcNAxkE5-3MeVEdSQJUG9IlYTyJeY0CinMNwZTVRMW0G9Z5cbpBcjHPalCf5CoMn52hsToLyqDy5u_2VbVzpbI93t78J_pgwWPQaXxTPeuUivnw4D4uvpyeXx5_L9ZdPZ8dH61LXFFLZt40yfZ6Fs7qvsWINqKrhBmirmOHvFBdGK9FXoAA6ZkR-pR2y1uiOGmiqw-LNzncK4_cZY5KDjRqdyx8c5ygFozUTjPGsZDulDmOMAXs5BTuocCMpyAW23MoFtlxgyxwZdi56_WA_dwOafyV_6WbBh50A85DXFoOM-h6AsQF1kma0__f_-KhcO-utVu4b3mDcjnPwGZ-kMjIJ8mJZ97JtSnPzpm6rP-EgqME</recordid><startdate>20120201</startdate><enddate>20120201</enddate><creator>Tzortzaki, Eleni G</creator><creator>Georgiou, Andreas</creator><creator>Kampas, Dimitrios</creator><creator>Lemessios, Marinos</creator><creator>Markatos, Miltiadis</creator><creator>Adamidi, Tonia</creator><creator>Samara, Katerina</creator><creator>Skoula, Georgia</creator><creator>Damianaki, Aggeliki</creator><creator>Schiza, Sophia</creator><creator>Tzanakis, Nikos</creator><creator>Siafakas, Nikolaos M</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20120201</creationdate><title>Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience</title><author>Tzortzaki, Eleni G ; Georgiou, Andreas ; Kampas, Dimitrios ; Lemessios, Marinos ; Markatos, Miltiadis ; Adamidi, Tonia ; Samara, Katerina ; Skoula, Georgia ; Damianaki, Aggeliki ; Schiza, Sophia ; Tzanakis, Nikos ; Siafakas, Nikolaos M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-f76adf962524f4e3260a365d017a2d58a59dca9f30a00b2d9a361be27dcb1d063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Administration, Inhalation</topic><topic>Adrenal Cortex Hormones - administration & dosage</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Aged</topic><topic>Allergy</topic><topic>Anti-Asthmatic Agents - administration & dosage</topic><topic>Anti-Asthmatic Agents - adverse effects</topic><topic>Anti-Asthmatic Agents - therapeutic use</topic><topic>Anti-IgE</topic><topic>Antibodies, Anti-Idiotypic - administration & dosage</topic><topic>Antibodies, Anti-Idiotypic - adverse effects</topic><topic>Antibodies, Anti-Idiotypic - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Asthma</topic><topic>Asthma - complications</topic><topic>Asthma - drug therapy</topic><topic>Asthma - etiology</topic><topic>Cohort Studies</topic><topic>Data Collection</topic><topic>Drug Therapy, Combination</topic><topic>Efficacy</topic><topic>Female</topic><topic>Forced Expiratory Volume</topic><topic>Humans</topic><topic>Hypersensitivity - complications</topic><topic>Immunoglobulin E</topic><topic>Long-Term Care</topic><topic>Male</topic><topic>Medical Education</topic><topic>Mediterranean Region</topic><topic>Middle Aged</topic><topic>Omalizumab</topic><topic>Pulmonary/Respiratory</topic><topic>Severe asthma</topic><topic>Spirometry</topic><topic>Therapy</topic><topic>Treatment Outcome</topic><topic>Vital Capacity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tzortzaki, Eleni G</creatorcontrib><creatorcontrib>Georgiou, Andreas</creatorcontrib><creatorcontrib>Kampas, Dimitrios</creatorcontrib><creatorcontrib>Lemessios, Marinos</creatorcontrib><creatorcontrib>Markatos, Miltiadis</creatorcontrib><creatorcontrib>Adamidi, Tonia</creatorcontrib><creatorcontrib>Samara, Katerina</creatorcontrib><creatorcontrib>Skoula, Georgia</creatorcontrib><creatorcontrib>Damianaki, Aggeliki</creatorcontrib><creatorcontrib>Schiza, Sophia</creatorcontrib><creatorcontrib>Tzanakis, Nikos</creatorcontrib><creatorcontrib>Siafakas, Nikolaos M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Pulmonary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tzortzaki, Eleni G</au><au>Georgiou, Andreas</au><au>Kampas, Dimitrios</au><au>Lemessios, Marinos</au><au>Markatos, Miltiadis</au><au>Adamidi, Tonia</au><au>Samara, Katerina</au><au>Skoula, Georgia</au><au>Damianaki, Aggeliki</au><au>Schiza, Sophia</au><au>Tzanakis, Nikos</au><au>Siafakas, Nikolaos M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience</atitle><jtitle>Pulmonary pharmacology & therapeutics</jtitle><addtitle>Pulm Pharmacol Ther</addtitle><date>2012-02-01</date><risdate>2012</risdate><volume>25</volume><issue>1</issue><spage>77</spage><epage>82</epage><pages>77-82</pages><issn>1094-5539</issn><eissn>1522-9629</eissn><abstract>Abstract Background Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. Objectives Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. Methods Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). Results Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (−65% p = 0.0002 at 1 year, and −70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months ( p = 0.017), 1 year ( p = 0.029) and 4 years ( p = 0.014) of omalizumab treatment. Conclusions This long-term “real-life” study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the “real-life” practice.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>22155001</pmid><doi>10.1016/j.pupt.2011.11.004</doi><tpages>6</tpages></addata></record> |
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| subjects | Administration, Inhalation Adrenal Cortex Hormones - administration & dosage Adrenal Cortex Hormones - therapeutic use Aged Allergy Anti-Asthmatic Agents - administration & dosage Anti-Asthmatic Agents - adverse effects Anti-Asthmatic Agents - therapeutic use Anti-IgE Antibodies, Anti-Idiotypic - administration & dosage Antibodies, Anti-Idiotypic - adverse effects Antibodies, Anti-Idiotypic - therapeutic use Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Asthma Asthma - complications Asthma - drug therapy Asthma - etiology Cohort Studies Data Collection Drug Therapy, Combination Efficacy Female Forced Expiratory Volume Humans Hypersensitivity - complications Immunoglobulin E Long-Term Care Male Medical Education Mediterranean Region Middle Aged Omalizumab Pulmonary/Respiratory Severe asthma Spirometry Therapy Treatment Outcome Vital Capacity |
| title | Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience |
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