Response to Omalizumab in Black and White Patients with Allergic Asthma
Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed. To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma. Data from placebo-control...
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Veröffentlicht in: | The journal of allergy and clinical immunology in practice (Cambridge, MA) MA), 2021-11, Vol.9 (11), p.4021-4028 |
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creator | Szefler, Stanley J. Jerschow, Elina Yoo, Bongin Janampally, Pranathi Pazwash, Hooman Holweg, Cecile T.J. Hudes, Golda |
description | Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed.
To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.
Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group.
This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study.
This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab. |
doi_str_mv | 10.1016/j.jaip.2021.07.013 |
format | Article |
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To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.
Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group.
This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study.
This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab.</description><identifier>ISSN: 2213-2198</identifier><identifier>EISSN: 2213-2201</identifier><identifier>DOI: 10.1016/j.jaip.2021.07.013</identifier><identifier>PMID: 34303017</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Anti-Asthmatic Agents - therapeutic use ; Asthma ; Asthma - drug therapy ; Clinical trials ; FDA approval ; Hispanic Americans ; Humans ; Immunoglobulin E ; Minority & ethnic groups ; Monoclonal antibodies ; Omalizumab ; Omalizumab - therapeutic use ; Patients ; Placebos ; Quality of Life ; Race ; Steroids ; Treatment Outcome</subject><ispartof>The journal of allergy and clinical immunology in practice (Cambridge, MA), 2021-11, Vol.9 (11), p.4021-4028</ispartof><rights>2021 The Authors</rights><rights>Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>2021. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-1bcc028ab3ed7e9039a019485aa25fdb4662981abdf0978510e0cba195f7c4983</citedby><cites>FETCH-LOGICAL-c428t-1bcc028ab3ed7e9039a019485aa25fdb4662981abdf0978510e0cba195f7c4983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34303017$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Szefler, Stanley J.</creatorcontrib><creatorcontrib>Jerschow, Elina</creatorcontrib><creatorcontrib>Yoo, Bongin</creatorcontrib><creatorcontrib>Janampally, Pranathi</creatorcontrib><creatorcontrib>Pazwash, Hooman</creatorcontrib><creatorcontrib>Holweg, Cecile T.J.</creatorcontrib><creatorcontrib>Hudes, Golda</creatorcontrib><title>Response to Omalizumab in Black and White Patients with Allergic Asthma</title><title>The journal of allergy and clinical immunology in practice (Cambridge, MA)</title><addtitle>J Allergy Clin Immunol Pract</addtitle><description>Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed.
To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.
Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group.
This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study.
This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab.</description><subject>Anti-Asthmatic Agents - therapeutic use</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Clinical trials</subject><subject>FDA approval</subject><subject>Hispanic Americans</subject><subject>Humans</subject><subject>Immunoglobulin E</subject><subject>Minority & ethnic groups</subject><subject>Monoclonal antibodies</subject><subject>Omalizumab</subject><subject>Omalizumab - therapeutic use</subject><subject>Patients</subject><subject>Placebos</subject><subject>Quality of Life</subject><subject>Race</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><issn>2213-2198</issn><issn>2213-2201</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1r3DAQQEVoSEKaP5BDEOTSy7ozkr22IJdtaNNCICEk5ChkedyV64-tJLe0v74ym_TQQ3UZHd48hsfYOUKGgOv3XdYZt8sECMygzADlATsRAuVKCMA3r39U1TE7C6GD9CosIYcjdixzCRKwPGE3DxR20xiIx4nfDaZ3v-fB1NyN_ENv7DduxoY_b10kfm-iozEG_tPFLd_0PfmvzvJNiNvBvGWHrekDnb3MU_b06ePj9efV7d3Nl-vN7crmooorrK0FUZlaUlOSAqkMoMqrwhhRtE2dr9dCVWjqpgVVVgUCga0NqqItba4qecre7b07P32fKUQ9uGCp781I0xy0KIoCl0AioZf_oN00-zFdlygl1yCLfBGKPWX9FIKnVu-8G4z_pRH0ItKdXkrrpbSGUqfSaeniRT3XAzV_V167JuBqD1Bq8cOR18GmeJYa58lG3Uzuf_4_2HuMhw</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Szefler, Stanley J.</creator><creator>Jerschow, Elina</creator><creator>Yoo, Bongin</creator><creator>Janampally, Pranathi</creator><creator>Pazwash, Hooman</creator><creator>Holweg, Cecile T.J.</creator><creator>Hudes, Golda</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>202111</creationdate><title>Response to Omalizumab in Black and White Patients with Allergic Asthma</title><author>Szefler, Stanley J. ; Jerschow, Elina ; Yoo, Bongin ; Janampally, Pranathi ; Pazwash, Hooman ; Holweg, Cecile T.J. ; Hudes, Golda</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-1bcc028ab3ed7e9039a019485aa25fdb4662981abdf0978510e0cba195f7c4983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Anti-Asthmatic Agents - therapeutic use</topic><topic>Asthma</topic><topic>Asthma - drug therapy</topic><topic>Clinical trials</topic><topic>FDA approval</topic><topic>Hispanic Americans</topic><topic>Humans</topic><topic>Immunoglobulin E</topic><topic>Minority & ethnic groups</topic><topic>Monoclonal antibodies</topic><topic>Omalizumab</topic><topic>Omalizumab - therapeutic use</topic><topic>Patients</topic><topic>Placebos</topic><topic>Quality of Life</topic><topic>Race</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Szefler, Stanley J.</creatorcontrib><creatorcontrib>Jerschow, Elina</creatorcontrib><creatorcontrib>Yoo, Bongin</creatorcontrib><creatorcontrib>Janampally, Pranathi</creatorcontrib><creatorcontrib>Pazwash, Hooman</creatorcontrib><creatorcontrib>Holweg, Cecile T.J.</creatorcontrib><creatorcontrib>Hudes, Golda</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>The journal of allergy and clinical immunology in practice (Cambridge, MA)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Szefler, Stanley J.</au><au>Jerschow, Elina</au><au>Yoo, Bongin</au><au>Janampally, Pranathi</au><au>Pazwash, Hooman</au><au>Holweg, Cecile T.J.</au><au>Hudes, Golda</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Response to Omalizumab in Black and White Patients with Allergic Asthma</atitle><jtitle>The journal of allergy and clinical immunology in practice (Cambridge, MA)</jtitle><addtitle>J Allergy Clin Immunol Pract</addtitle><date>2021-11</date><risdate>2021</risdate><volume>9</volume><issue>11</issue><spage>4021</spage><epage>4028</epage><pages>4021-4028</pages><issn>2213-2198</issn><eissn>2213-2201</eissn><abstract>Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed.
To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.
Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group.
This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study.
This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34303017</pmid><doi>10.1016/j.jaip.2021.07.013</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Anti-Asthmatic Agents - therapeutic use Asthma Asthma - drug therapy Clinical trials FDA approval Hispanic Americans Humans Immunoglobulin E Minority & ethnic groups Monoclonal antibodies Omalizumab Omalizumab - therapeutic use Patients Placebos Quality of Life Race Steroids Treatment Outcome |
title | Response to Omalizumab in Black and White Patients with Allergic Asthma |
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