Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial
We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE). We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the...
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| Veröffentlicht in: | Gut 2023-10, Vol.72 (10), p.1828-1837 |
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| creator | Dellon, Evan S Peterson, Kathryn A Mitlyng, Benjamin L Iuga, Alina Bookhout, Christine E Cortright, Lindsay M Walker, Kacie B Gee, Timothy S McGee, Sarah J Cameron, Brenderia A Galanko, Joseph A Woosley, John T Eluri, Swathi Moist, Susan E Hirano, Ikuo |
| description | We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).
We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).
Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p |
| doi_str_mv | 10.1136/gutjnl-2023-330337 |
| format | Article |
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We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).
Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.
Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement.
NCT03656380.</description><identifier>ISSN: 0017-5749</identifier><identifier>ISSN: 1468-3288</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2023-330337</identifier><identifier>PMID: 37423717</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adolescent ; Adult ; Antibodies, Monoclonal, Humanized ; Clinical trials ; Deglutition Disorders - drug therapy ; Deglutition Disorders - etiology ; Disease ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Dysphagia ; Endoscopy ; Eosinophilic Esophagitis - drug therapy ; Eosinophils - pathology ; Esophageal diseases ; Esophagitis ; Humans ; Interleukin 5 ; Leukocytes (eosinophilic) ; Monoclonal antibodies ; Pathogenesis ; Patients ; Placebos ; Steroids ; Treatment Outcome</subject><ispartof>Gut, 2023-10, Vol.72 (10), p.1828-1837</ispartof><rights>Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2023 Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c359t-ce48f894c4a9a72df2822b3e823d7df4305299b126b75d55d33f9ac8eab29eb83</citedby><cites>FETCH-LOGICAL-c359t-ce48f894c4a9a72df2822b3e823d7df4305299b126b75d55d33f9ac8eab29eb83</cites><orcidid>0000-0003-1167-1101 ; 0000-0001-7688-9377</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37423717$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dellon, Evan S</creatorcontrib><creatorcontrib>Peterson, Kathryn A</creatorcontrib><creatorcontrib>Mitlyng, Benjamin L</creatorcontrib><creatorcontrib>Iuga, Alina</creatorcontrib><creatorcontrib>Bookhout, Christine E</creatorcontrib><creatorcontrib>Cortright, Lindsay M</creatorcontrib><creatorcontrib>Walker, Kacie B</creatorcontrib><creatorcontrib>Gee, Timothy S</creatorcontrib><creatorcontrib>McGee, Sarah J</creatorcontrib><creatorcontrib>Cameron, Brenderia A</creatorcontrib><creatorcontrib>Galanko, Joseph A</creatorcontrib><creatorcontrib>Woosley, John T</creatorcontrib><creatorcontrib>Eluri, Swathi</creatorcontrib><creatorcontrib>Moist, Susan E</creatorcontrib><creatorcontrib>Hirano, Ikuo</creatorcontrib><title>Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial</title><title>Gut</title><addtitle>Gut</addtitle><description>We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).
We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).
Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.
Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement.
NCT03656380.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Clinical trials</subject><subject>Deglutition Disorders - drug therapy</subject><subject>Deglutition Disorders - etiology</subject><subject>Disease</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Dysphagia</subject><subject>Endoscopy</subject><subject>Eosinophilic Esophagitis - drug therapy</subject><subject>Eosinophils - pathology</subject><subject>Esophageal diseases</subject><subject>Esophagitis</subject><subject>Humans</subject><subject>Interleukin 5</subject><subject>Leukocytes (eosinophilic)</subject><subject>Monoclonal antibodies</subject><subject>Pathogenesis</subject><subject>Patients</subject><subject>Placebos</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><issn>0017-5749</issn><issn>1468-3288</issn><issn>1468-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kc2KFTEQRoMoznX0BVxIwI2LaU1S6U7iTgYdhRE3um7yUz2TS7pzTboRfRif1VzuOAsXrlJFzld8cAh5ztlrzmF4c7Ot-yV1ggnoABiAekB2XA66A6H1Q7JjjKuuV9KckSe17hljWhv-mJyBkgIUVzvy-zMecoq_ttk6OuVC14J2nXFZaZ6oDTlh9W2r1C6h7Vtq44-43lLMNS75cBtT9DRjbaO9iWusb6mlc-PiMVfwgpYWzXOsGC5oyJtL2LkUl7YdkvXocudzI3NKGKhvP9Hb1IpEm56SR5NNFZ_dvefk24f3Xy8_dtdfrj5dvrvuPPRm7TxKPWkjvbTGKhEmoYVwgFpAUGGSwHphjONicKoPfR8AJmO9RuuEQafhnLw63T2U_H3Duo6tr8eU7IJ5q6PQvZQAfBga-vIfdJ-3srR2jRokbzqE-j8FUvUCjGyUOFG-5FoLTuOhxNmWnyNn49HxeHI8Hh2PJ8ct9OLu9OZmDPeRv1LhD1Mvpo0</recordid><startdate>20231001</startdate><enddate>20231001</enddate><creator>Dellon, Evan S</creator><creator>Peterson, Kathryn A</creator><creator>Mitlyng, Benjamin L</creator><creator>Iuga, Alina</creator><creator>Bookhout, Christine E</creator><creator>Cortright, Lindsay M</creator><creator>Walker, Kacie B</creator><creator>Gee, Timothy S</creator><creator>McGee, Sarah J</creator><creator>Cameron, Brenderia A</creator><creator>Galanko, Joseph A</creator><creator>Woosley, John T</creator><creator>Eluri, Swathi</creator><creator>Moist, Susan E</creator><creator>Hirano, Ikuo</creator><general>BMJ Publishing Group 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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</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>BTHHO</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>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1167-1101</orcidid><orcidid>https://orcid.org/0000-0001-7688-9377</orcidid></search><sort><creationdate>20231001</creationdate><title>Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial</title><author>Dellon, Evan S ; Peterson, Kathryn A ; Mitlyng, Benjamin L ; Iuga, Alina ; Bookhout, Christine E ; Cortright, Lindsay M ; Walker, Kacie B ; Gee, Timothy S ; McGee, Sarah J ; Cameron, Brenderia A ; Galanko, Joseph A ; Woosley, John T ; Eluri, Swathi ; Moist, Susan E ; Hirano, Ikuo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c359t-ce48f894c4a9a72df2822b3e823d7df4305299b126b75d55d33f9ac8eab29eb83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Clinical trials</topic><topic>Deglutition Disorders - drug therapy</topic><topic>Deglutition Disorders - etiology</topic><topic>Disease</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Drug dosages</topic><topic>Dysphagia</topic><topic>Endoscopy</topic><topic>Eosinophilic Esophagitis - drug therapy</topic><topic>Eosinophils - pathology</topic><topic>Esophageal diseases</topic><topic>Esophagitis</topic><topic>Humans</topic><topic>Interleukin 5</topic><topic>Leukocytes (eosinophilic)</topic><topic>Monoclonal antibodies</topic><topic>Pathogenesis</topic><topic>Patients</topic><topic>Placebos</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dellon, Evan S</creatorcontrib><creatorcontrib>Peterson, Kathryn A</creatorcontrib><creatorcontrib>Mitlyng, Benjamin L</creatorcontrib><creatorcontrib>Iuga, Alina</creatorcontrib><creatorcontrib>Bookhout, Christine E</creatorcontrib><creatorcontrib>Cortright, Lindsay M</creatorcontrib><creatorcontrib>Walker, Kacie B</creatorcontrib><creatorcontrib>Gee, Timothy S</creatorcontrib><creatorcontrib>McGee, Sarah J</creatorcontrib><creatorcontrib>Cameron, Brenderia A</creatorcontrib><creatorcontrib>Galanko, Joseph A</creatorcontrib><creatorcontrib>Woosley, John T</creatorcontrib><creatorcontrib>Eluri, Swathi</creatorcontrib><creatorcontrib>Moist, Susan E</creatorcontrib><creatorcontrib>Hirano, Ikuo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dellon, Evan S</au><au>Peterson, Kathryn A</au><au>Mitlyng, Benjamin L</au><au>Iuga, Alina</au><au>Bookhout, Christine E</au><au>Cortright, Lindsay M</au><au>Walker, Kacie B</au><au>Gee, Timothy S</au><au>McGee, Sarah J</au><au>Cameron, Brenderia A</au><au>Galanko, Joseph A</au><au>Woosley, John T</au><au>Eluri, Swathi</au><au>Moist, Susan E</au><au>Hirano, Ikuo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2023-10-01</date><risdate>2023</risdate><volume>72</volume><issue>10</issue><spage>1828</spage><epage>1837</epage><pages>1828-1837</pages><issn>0017-5749</issn><issn>1468-3288</issn><eissn>1468-3288</eissn><abstract>We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).
We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).
Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.
Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement.
NCT03656380.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>37423717</pmid><doi>10.1136/gutjnl-2023-330337</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-1167-1101</orcidid><orcidid>https://orcid.org/0000-0001-7688-9377</orcidid></addata></record> |
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| ispartof | Gut, 2023-10, Vol.72 (10), p.1828-1837 |
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| subjects | Adolescent Adult Antibodies, Monoclonal, Humanized Clinical trials Deglutition Disorders - drug therapy Deglutition Disorders - etiology Disease Double-Blind Method Double-blind studies Drug dosages Dysphagia Endoscopy Eosinophilic Esophagitis - drug therapy Eosinophils - pathology Esophageal diseases Esophagitis Humans Interleukin 5 Leukocytes (eosinophilic) Monoclonal antibodies Pathogenesis Patients Placebos Steroids Treatment Outcome |
| title | Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial |
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