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Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis
Patients with severe uncontrolled asthma still experience acute asthma symptoms and exacerbations, particularly those with non-eosinophilic inflammation who take the maximum amount of standard drug therapy. Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of as...
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Published in: | Scientific reports 2022-12, Vol.12 (1), p.20905-13, Article 20905 |
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description | Patients with severe uncontrolled asthma still experience acute asthma symptoms and exacerbations, particularly those with non-eosinophilic inflammation who take the maximum amount of standard drug therapy. Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease’s baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = − 0.74, (95% CI [− 1.04, − 0.44], p |
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Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease’s baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = − 0.74, (95% CI [− 1.04, − 0.44], p < 0.00001)), asthma control questionnaire-6 (ACQ-6) Score MD = − 0.32, (95% CI [− 0.43, − 0.21], p < 0.00001)), blood eosinophil count (MD = − 139.38 cells/mcL, (95% CI [− 150.37, − 128.39], p < 0.00001)), feNO (MD = − 10 ppb, (95% CI [− 15.81, − 4.18], p = 0.0008)) and serum total IgE (MD = − 123.51 UI/ml, (95% CI [− 206.52, − 40.50], p = 0.004)). All tezepelumab groups had higher pre-bronchodilator forced expiratory volume in 1 s than the placebo group (MD = 0.16, (95% CI [0.10, 0.21], p < 0.00001)). Higher efficacy and safety profile was detected for tezepelumab to control the exacerbations of severe uncontrolled adult asthmatics.</description><identifier>ISSN: 2045-2322</identifier><identifier>EISSN: 2045-2322</identifier><identifier>DOI: 10.1038/s41598-022-24763-9</identifier><identifier>PMID: 36463281</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308 ; 692/699 ; 692/700 ; Adult ; Antibodies, Monoclonal, Humanized - adverse effects ; Asthma ; Asthma - drug therapy ; Bronchodilators ; Clinical trials ; Drug therapy ; Eosinophils ; Humanities and Social Sciences ; Humans ; Immunoglobulin E ; Leukocytes (eosinophilic) ; Meta-analysis ; Monoclonal antibodies ; multidisciplinary ; Placebos ; Respiratory function ; Safety ; Science ; Science (multidisciplinary) ; Status Asthmaticus</subject><ispartof>Scientific reports, 2022-12, Vol.12 (1), p.20905-13, Article 20905</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-329fe7ffc27cc785618acb7db06424cf1b10ab0c8e2cf3ad4c960bad0ce92393</citedby><cites>FETCH-LOGICAL-c470t-329fe7ffc27cc785618acb7db06424cf1b10ab0c8e2cf3ad4c960bad0ce92393</cites><orcidid>0000-0003-4120-9161</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2745499071/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2745499071?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36463281$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shaban Abdelgalil, Mahmoud</creatorcontrib><creatorcontrib>Ahmed Elrashedy, Asmaa</creatorcontrib><creatorcontrib>Awad, Ahmed K.</creatorcontrib><creatorcontrib>Reda Gad, Eman</creatorcontrib><creatorcontrib>Ali, Mahmoud M.</creatorcontrib><creatorcontrib>Abdelmoez Farahat, Ramadan</creatorcontrib><creatorcontrib>Hassan Shawki, Bassant</creatorcontrib><creatorcontrib>Abd-ElGawad, Mohamed</creatorcontrib><title>Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis</title><title>Scientific reports</title><addtitle>Sci Rep</addtitle><addtitle>Sci Rep</addtitle><description>Patients with severe uncontrolled asthma still experience acute asthma symptoms and exacerbations, particularly those with non-eosinophilic inflammation who take the maximum amount of standard drug therapy. Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease’s baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = − 0.74, (95% CI [− 1.04, − 0.44], p < 0.00001)), asthma control questionnaire-6 (ACQ-6) Score MD = − 0.32, (95% CI [− 0.43, − 0.21], p < 0.00001)), blood eosinophil count (MD = − 139.38 cells/mcL, (95% CI [− 150.37, − 128.39], p < 0.00001)), feNO (MD = − 10 ppb, (95% CI [− 15.81, − 4.18], p = 0.0008)) and serum total IgE (MD = − 123.51 UI/ml, (95% CI [− 206.52, − 40.50], p = 0.004)). All tezepelumab groups had higher pre-bronchodilator forced expiratory volume in 1 s than the placebo group (MD = 0.16, (95% CI [0.10, 0.21], p < 0.00001)). Higher efficacy and safety profile was detected for tezepelumab to control the exacerbations of severe uncontrolled adult asthmatics.</description><subject>692/308</subject><subject>692/699</subject><subject>692/700</subject><subject>Adult</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Bronchodilators</subject><subject>Clinical trials</subject><subject>Drug therapy</subject><subject>Eosinophils</subject><subject>Humanities and Social Sciences</subject><subject>Humans</subject><subject>Immunoglobulin E</subject><subject>Leukocytes (eosinophilic)</subject><subject>Meta-analysis</subject><subject>Monoclonal antibodies</subject><subject>multidisciplinary</subject><subject>Placebos</subject><subject>Respiratory function</subject><subject>Safety</subject><subject>Science</subject><subject>Science (multidisciplinary)</subject><subject>Status Asthmaticus</subject><issn>2045-2322</issn><issn>2045-2322</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9ks9u3CAQxq2qVROleYEeKqSenQLGxvRQqYr6J1KkHpo7GvCw65VtXMAbbV6gr12yTtPkUi4gZub3DcNXFG8ZvWC0aj9EwWrVlpTzkgvZVKV6UZxyKuqSV5y_fHI-Kc5j3NG8aq4EU6-Lk6oRTcVbdlr8_gkO04HA1BF0rrdgD8Q7kvAOZxyWEQzZxwsyD2DReNJPBLplSGSG1OOUIrnt05ZE3GNAskzWTyn4YcCOQEzbET4SIPEQE465wJKA-x5vj3IjJihhguEQ-_imeOVgiHj-sJ8VN1-_3Fx-L69_fLu6_HxdWiFpKiuuHErnLJfWyrZuWAvWyM7QRnBhHTOMgqG2RW5dBZ2wqqEGOmpR8UpVZ8XViu087PQc-hHCQXvo9fHCh42GkPscUDeGS2RCAK9RCGGycOt42wlUUknTZtanlTUvZsTO5mkEGJ5Bn0emfqs3fq-VZEo0TQa8fwAE_2vBmPTOLyEPJGouRS2UopLlLL5m2eBjDOgeFRjV91bQqxV0toI-WkHfv_Pd094eS_5-fE6o1oSYQ9MGwz_t_2D_AFnXwrI</recordid><startdate>20221203</startdate><enddate>20221203</enddate><creator>Shaban Abdelgalil, Mahmoud</creator><creator>Ahmed Elrashedy, Asmaa</creator><creator>Awad, Ahmed K.</creator><creator>Reda Gad, Eman</creator><creator>Ali, Mahmoud M.</creator><creator>Abdelmoez Farahat, Ramadan</creator><creator>Hassan Shawki, Bassant</creator><creator>Abd-ElGawad, Mohamed</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><general>Nature Portfolio</general><scope>C6C</scope><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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88E</scope><scope>88I</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0003-4120-9161</orcidid></search><sort><creationdate>20221203</creationdate><title>Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis</title><author>Shaban Abdelgalil, Mahmoud ; Ahmed Elrashedy, Asmaa ; Awad, Ahmed K. ; Reda Gad, Eman ; Ali, Mahmoud M. ; Abdelmoez Farahat, Ramadan ; Hassan Shawki, Bassant ; Abd-ElGawad, Mohamed</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-329fe7ffc27cc785618acb7db06424cf1b10ab0c8e2cf3ad4c960bad0ce92393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>692/308</topic><topic>692/699</topic><topic>692/700</topic><topic>Adult</topic><topic>Antibodies, Monoclonal, Humanized - 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Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease’s baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = − 0.74, (95% CI [− 1.04, − 0.44], p < 0.00001)), asthma control questionnaire-6 (ACQ-6) Score MD = − 0.32, (95% CI [− 0.43, − 0.21], p < 0.00001)), blood eosinophil count (MD = − 139.38 cells/mcL, (95% CI [− 150.37, − 128.39], p < 0.00001)), feNO (MD = − 10 ppb, (95% CI [− 15.81, − 4.18], p = 0.0008)) and serum total IgE (MD = − 123.51 UI/ml, (95% CI [− 206.52, − 40.50], p = 0.004)). All tezepelumab groups had higher pre-bronchodilator forced expiratory volume in 1 s than the placebo group (MD = 0.16, (95% CI [0.10, 0.21], p < 0.00001)). Higher efficacy and safety profile was detected for tezepelumab to control the exacerbations of severe uncontrolled adult asthmatics.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>36463281</pmid><doi>10.1038/s41598-022-24763-9</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0003-4120-9161</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | 692/308 692/699 692/700 Adult Antibodies, Monoclonal, Humanized - adverse effects Asthma Asthma - drug therapy Bronchodilators Clinical trials Drug therapy Eosinophils Humanities and Social Sciences Humans Immunoglobulin E Leukocytes (eosinophilic) Meta-analysis Monoclonal antibodies multidisciplinary Placebos Respiratory function Safety Science Science (multidisciplinary) Status Asthmaticus |
title | Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis |
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