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Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials
Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere. Thi...
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| Published in: | The Journal of dermatological treatment 2024-12, Vol.35 (1), p.2324833 |
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| container_title | The Journal of dermatological treatment |
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| creator | Hebert, Adelaide A Flohr, Carsten Hong, H Chih-Ho Irvine, Alan D Pierce, Evangeline Elmaraghy, Hany Pillai, Sreekumar Dawson, Zach Chen, Sherry Armengol, Clara Siegfried, Elaine Weidinger, Stephan |
| description | Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.
This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.
Eligible adolescents (≥12 to |
| doi_str_mv | 10.1080/09546634.2024.2324833 |
| format | article |
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This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.
Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.
Pooled ADvocate1&2 16-week results in lebrikizumab (
= 67) vs placebo (
= 35) were: IGA (0,1) 46.6% vs 14.3% (
< 0.01), EASI 75 62.0% vs 17.3% (
< 0.001), EASI 90 40.7% vs 11.5% (
< 0.01), Pruritus NRS 48.9% vs 13.1% (
< 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (
= 0.137). Corresponding results for ADhere, (lebrikizumab + TCS,
= 32; placebo + TCS,
= 14), were consistent.
Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.]]></description><identifier>ISSN: 0954-6634</identifier><identifier>ISSN: 1471-1753</identifier><identifier>EISSN: 1471-1753</identifier><identifier>DOI: 10.1080/09546634.2024.2324833</identifier><identifier>PMID: 38735650</identifier><language>eng</language><publisher>England: Taylor & Francis Group</publisher><subject>Adolescent ; Adolescents ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - therapeutic use ; atopic dermatitis ; Child ; Dermatitis, Atopic - drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; efficacy ; Female ; Humans ; Injections, Subcutaneous ; lebrikizumab ; Male ; Patient Reported Outcome Measures ; quality of life ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>The Journal of dermatological treatment, 2024-12, Vol.35 (1), p.2324833</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c370t-e9c77154c249292422430ba1ccd51f9323800034add945cddc29b273c8854333</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/38735650$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hebert, Adelaide A</creatorcontrib><creatorcontrib>Flohr, Carsten</creatorcontrib><creatorcontrib>Hong, H Chih-Ho</creatorcontrib><creatorcontrib>Irvine, Alan D</creatorcontrib><creatorcontrib>Pierce, Evangeline</creatorcontrib><creatorcontrib>Elmaraghy, Hany</creatorcontrib><creatorcontrib>Pillai, Sreekumar</creatorcontrib><creatorcontrib>Dawson, Zach</creatorcontrib><creatorcontrib>Chen, Sherry</creatorcontrib><creatorcontrib>Armengol, Clara</creatorcontrib><creatorcontrib>Siegfried, Elaine</creatorcontrib><creatorcontrib>Weidinger, Stephan</creatorcontrib><title>Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials</title><title>The Journal of dermatological treatment</title><addtitle>J Dermatolog Treat</addtitle><description><![CDATA[Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.
This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.
Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.
Pooled ADvocate1&2 16-week results in lebrikizumab (
= 67) vs placebo (
= 35) were: IGA (0,1) 46.6% vs 14.3% (
< 0.01), EASI 75 62.0% vs 17.3% (
< 0.001), EASI 90 40.7% vs 11.5% (
< 0.01), Pruritus NRS 48.9% vs 13.1% (
< 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (
= 0.137). Corresponding results for ADhere, (lebrikizumab + TCS,
= 32; placebo + TCS,
= 14), were consistent.
Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.]]></description><subject>Adolescent</subject><subject>Adolescents</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>atopic dermatitis</subject><subject>Child</subject><subject>Dermatitis, Atopic - drug therapy</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>efficacy</subject><subject>Female</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>lebrikizumab</subject><subject>Male</subject><subject>Patient Reported Outcome Measures</subject><subject>quality of life</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><issn>0954-6634</issn><issn>1471-1753</issn><issn>1471-1753</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNo9Uctu1TAQjRCI3hY-AeQlmxTbYycxO1QVqFSJTfeWY0-4bpM42A5V-yX93Drc227mSKPzGM2pqk-MnjPa0a9USdE0IM455WUAFx3Am2rHRMtq1kp4W-02Tr2RTqrTlG4pZdDQ7n11Al0LspF0Vz1dDoO3xj6QMJAR--jv_OM6mZ74mRgXRkwW50wWk33BRO593pMpOIwmY51DnfAfRiQmh8VbUvZToWafvhHW1PeIdyRiWsciHWKYSN5HRBLN7MLkH9GRZW8SEiB29HO5ZCQ5ejOmD9W7oQB-POJZdfPj8ubiV339--fVxffr2kJLc43Kti2TwnKhuOKCcwG0N8xaJ9mggENHKQVhnFNCWucsVz1vwXadFABwVl0dbF0wt3qJfjLxQQfj9f9FiH-0idnbEXUvcWB930kzMIFs6JvOMekEVcq1Pcji9eXgtcTwd8WU9eTL98bRzBjWpIFKUTK52mLlgWpjSCni8BrNqN761S_96q1ffey36D4fI9Z-QveqeikUngHPsqIB</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Hebert, Adelaide A</creator><creator>Flohr, Carsten</creator><creator>Hong, H Chih-Ho</creator><creator>Irvine, Alan D</creator><creator>Pierce, Evangeline</creator><creator>Elmaraghy, Hany</creator><creator>Pillai, Sreekumar</creator><creator>Dawson, Zach</creator><creator>Chen, Sherry</creator><creator>Armengol, Clara</creator><creator>Siegfried, Elaine</creator><creator>Weidinger, Stephan</creator><general>Taylor & Francis Group</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><scope>DOA</scope></search><sort><creationdate>202412</creationdate><title>Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials</title><author>Hebert, Adelaide A ; Flohr, Carsten ; Hong, H Chih-Ho ; Irvine, Alan D ; Pierce, Evangeline ; Elmaraghy, Hany ; Pillai, Sreekumar ; Dawson, Zach ; Chen, Sherry ; Armengol, Clara ; Siegfried, Elaine ; Weidinger, Stephan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c370t-e9c77154c249292422430ba1ccd51f9323800034add945cddc29b273c8854333</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Adolescents</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>atopic dermatitis</topic><topic>Child</topic><topic>Dermatitis, Atopic - drug therapy</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>efficacy</topic><topic>Female</topic><topic>Humans</topic><topic>Injections, Subcutaneous</topic><topic>lebrikizumab</topic><topic>Male</topic><topic>Patient Reported Outcome Measures</topic><topic>quality of life</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hebert, Adelaide A</creatorcontrib><creatorcontrib>Flohr, Carsten</creatorcontrib><creatorcontrib>Hong, H Chih-Ho</creatorcontrib><creatorcontrib>Irvine, Alan D</creatorcontrib><creatorcontrib>Pierce, Evangeline</creatorcontrib><creatorcontrib>Elmaraghy, Hany</creatorcontrib><creatorcontrib>Pillai, Sreekumar</creatorcontrib><creatorcontrib>Dawson, Zach</creatorcontrib><creatorcontrib>Chen, Sherry</creatorcontrib><creatorcontrib>Armengol, Clara</creatorcontrib><creatorcontrib>Siegfried, Elaine</creatorcontrib><creatorcontrib>Weidinger, Stephan</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><collection>DOAJ Directory of Open Access Journals</collection><jtitle>The Journal of dermatological treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hebert, Adelaide A</au><au>Flohr, Carsten</au><au>Hong, H Chih-Ho</au><au>Irvine, Alan D</au><au>Pierce, Evangeline</au><au>Elmaraghy, Hany</au><au>Pillai, Sreekumar</au><au>Dawson, Zach</au><au>Chen, Sherry</au><au>Armengol, Clara</au><au>Siegfried, Elaine</au><au>Weidinger, Stephan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials</atitle><jtitle>The Journal of dermatological treatment</jtitle><addtitle>J Dermatolog Treat</addtitle><date>2024-12</date><risdate>2024</risdate><volume>35</volume><issue>1</issue><spage>2324833</spage><pages>2324833-</pages><issn>0954-6634</issn><issn>1471-1753</issn><eissn>1471-1753</eissn><abstract><![CDATA[Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.
This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.
Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.
Pooled ADvocate1&2 16-week results in lebrikizumab (
= 67) vs placebo (
= 35) were: IGA (0,1) 46.6% vs 14.3% (
< 0.01), EASI 75 62.0% vs 17.3% (
< 0.001), EASI 90 40.7% vs 11.5% (
< 0.01), Pruritus NRS 48.9% vs 13.1% (
< 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (
= 0.137). Corresponding results for ADhere, (lebrikizumab + TCS,
= 32; placebo + TCS,
= 14), were consistent.
Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.]]></abstract><cop>England</cop><pub>Taylor & Francis Group</pub><pmid>38735650</pmid><doi>10.1080/09546634.2024.2324833</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adolescents Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - therapeutic use atopic dermatitis Child Dermatitis, Atopic - drug therapy Double-Blind Method Drug Therapy, Combination efficacy Female Humans Injections, Subcutaneous lebrikizumab Male Patient Reported Outcome Measures quality of life Severity of Illness Index Treatment Outcome |
| title | Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials |
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