Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study
Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (May...
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| Veröffentlicht in: | Gut 2015-06, Vol.64 (6), p.894-900 |
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| creator | Reinisch, Walter Panés, Julián Khurana, Sunil Toth, Gabor Hua, Fei Comer, Gail M Hinz, Michelle Page, Karen O'Toole, Margot Moorehead, Tara McDonnell Zhu, Hua Sun, YanHui Cataldi, Fabio |
| description | Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and |
| doi_str_mv | 10.1136/gutjnl-2014-308337 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1808655030</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1808655030</sourcerecordid><originalsourceid>FETCH-LOGICAL-b435t-8a69db140a0ea7ab7145f6fb8e7bd5e9f6a2ed370ccabed04267938581c868783</originalsourceid><addsrcrecordid>eNqNkcuKFDEUhoMoTjv6Ai4k4MbFlCaVyqXcDY2XhgE3zrrI5USrraq0uQyUb-Bbm7ZGF66EA1n83_k55EPoOSWvKWXizZeSj8vUtIR2DSOKMfkA7WgnVMNapR6iHSFUNlx2_QV6ktKREKJUTx-ji5ZzISnlO_Tzeonl27j8KLM2V1gvdfLYjEuGOME5wZThOSzBTmHR0-_YBLde4Rppm8c7wLf7txi8H622awUcTtpDXrGPYcYan77qBPhw0DjWMMxjAofnMuXRwpIj4JSLW5-iR15PCZ7dv5fo9v27z_uPzc2nD4f99U1jOsZzo7TonaEd0QS01EbSjnvhjQJpHIfeC92CY5JYqw040rVC9kxxRa0SSip2iV5tvacYvhdIeagHWZgmvUAoaaCKKME5YaSiL_9Bj6HE-guVkrLvhKCMVqrdKBtDShH8cIrjrOM6UDKcRQ2bqOEsathE1aUX99XFzOD-rvwxU4FmA8x8_J_CX0zOn2w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1779466131</pqid></control><display><type>article</type><title>Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><source>PubMed Central</source><creator>Reinisch, Walter ; Panés, Julián ; Khurana, Sunil ; Toth, Gabor ; Hua, Fei ; Comer, Gail M ; Hinz, Michelle ; Page, Karen ; O'Toole, Margot ; Moorehead, Tara McDonnell ; Zhu, Hua ; Sun, YanHui ; Cataldi, Fabio</creator><creatorcontrib>Reinisch, Walter ; Panés, Julián ; Khurana, Sunil ; Toth, Gabor ; Hua, Fei ; Comer, Gail M ; Hinz, Michelle ; Page, Karen ; O'Toole, Margot ; Moorehead, Tara McDonnell ; Zhu, Hua ; Sun, YanHui ; Cataldi, Fabio</creatorcontrib><description>Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels. Results The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups. Conclusions A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13. Trial registration number ClinicalTrials.gov number NCT01284062.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2014-308337</identifier><identifier>PMID: 25567115</identifier><identifier>CODEN: GUTTAK</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Administration, Intravenous ; Adolescent ; Adult ; Aged ; Analysis of Variance ; Antibodies, Monoclonal, Humanized - pharmacokinetics ; Antibodies, Monoclonal, Humanized - therapeutic use ; Biomarkers ; Biomarkers - blood ; Biopsy ; Clinical medicine ; Colitis, Ulcerative - blood ; Colitis, Ulcerative - drug therapy ; Colitis, Ulcerative - pathology ; Colon - pathology ; Crohn's disease ; Cytokines ; Dose-Response Relationship, Drug ; Double-Blind Method ; Endoscopy ; Eosinophils - cytology ; Eosinophils - drug effects ; Feces - chemistry ; Female ; Humans ; Immunosuppressive Agents - therapeutic use ; Interleukin-13 - antagonists & inhibitors ; Interleukin-13 - blood ; Leukocyte Count ; Leukocyte L1 Antigen Complex - analysis ; Male ; Middle Aged ; Molecular weight ; Remission Induction ; Rodents ; TNF inhibitors ; Treatment Outcome ; Tumor necrosis factor-TNF ; Young Adult</subject><ispartof>Gut, 2015-06, Vol.64 (6), p.894-900</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</rights><rights>Copyright: 2015 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b435t-8a69db140a0ea7ab7145f6fb8e7bd5e9f6a2ed370ccabed04267938581c868783</citedby><cites>FETCH-LOGICAL-b435t-8a69db140a0ea7ab7145f6fb8e7bd5e9f6a2ed370ccabed04267938581c868783</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://gut.bmj.com/content/64/6/894.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://gut.bmj.com/content/64/6/894.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,777,781,3183,23552,27905,27906,77349,77380</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25567115$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Reinisch, Walter</creatorcontrib><creatorcontrib>Panés, Julián</creatorcontrib><creatorcontrib>Khurana, Sunil</creatorcontrib><creatorcontrib>Toth, Gabor</creatorcontrib><creatorcontrib>Hua, Fei</creatorcontrib><creatorcontrib>Comer, Gail M</creatorcontrib><creatorcontrib>Hinz, Michelle</creatorcontrib><creatorcontrib>Page, Karen</creatorcontrib><creatorcontrib>O'Toole, Margot</creatorcontrib><creatorcontrib>Moorehead, Tara McDonnell</creatorcontrib><creatorcontrib>Zhu, Hua</creatorcontrib><creatorcontrib>Sun, YanHui</creatorcontrib><creatorcontrib>Cataldi, Fabio</creatorcontrib><title>Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study</title><title>Gut</title><addtitle>Gut</addtitle><description>Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels. Results The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups. Conclusions A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13. Trial registration number ClinicalTrials.gov number NCT01284062.</description><subject>Administration, Intravenous</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Antibodies, Monoclonal, Humanized - pharmacokinetics</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Biomarkers</subject><subject>Biomarkers - blood</subject><subject>Biopsy</subject><subject>Clinical medicine</subject><subject>Colitis, Ulcerative - blood</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Colitis, Ulcerative - pathology</subject><subject>Colon - pathology</subject><subject>Crohn's disease</subject><subject>Cytokines</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Endoscopy</subject><subject>Eosinophils - cytology</subject><subject>Eosinophils - drug effects</subject><subject>Feces - chemistry</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Interleukin-13 - antagonists & inhibitors</subject><subject>Interleukin-13 - blood</subject><subject>Leukocyte Count</subject><subject>Leukocyte L1 Antigen Complex - analysis</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Molecular weight</subject><subject>Remission Induction</subject><subject>Rodents</subject><subject>TNF inhibitors</subject><subject>Treatment Outcome</subject><subject>Tumor necrosis factor-TNF</subject><subject>Young 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efficacy and safety from a phase IIa randomised multicentre study</title><author>Reinisch, Walter ; Panés, Julián ; Khurana, Sunil ; Toth, Gabor ; Hua, Fei ; Comer, Gail M ; Hinz, Michelle ; Page, Karen ; O'Toole, Margot ; Moorehead, Tara McDonnell ; Zhu, Hua ; Sun, YanHui ; Cataldi, Fabio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b435t-8a69db140a0ea7ab7145f6fb8e7bd5e9f6a2ed370ccabed04267938581c868783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Administration, Intravenous</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Antibodies, Monoclonal, Humanized - pharmacokinetics</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Biomarkers</topic><topic>Biomarkers - blood</topic><topic>Biopsy</topic><topic>Clinical medicine</topic><topic>Colitis, Ulcerative - blood</topic><topic>Colitis, Ulcerative - drug therapy</topic><topic>Colitis, Ulcerative - pathology</topic><topic>Colon - pathology</topic><topic>Crohn's disease</topic><topic>Cytokines</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Endoscopy</topic><topic>Eosinophils - cytology</topic><topic>Eosinophils - drug effects</topic><topic>Feces - chemistry</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Interleukin-13 - antagonists & inhibitors</topic><topic>Interleukin-13 - blood</topic><topic>Leukocyte Count</topic><topic>Leukocyte L1 Antigen Complex - analysis</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Molecular weight</topic><topic>Remission Induction</topic><topic>Rodents</topic><topic>TNF inhibitors</topic><topic>Treatment Outcome</topic><topic>Tumor necrosis factor-TNF</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reinisch, Walter</creatorcontrib><creatorcontrib>Panés, Julián</creatorcontrib><creatorcontrib>Khurana, Sunil</creatorcontrib><creatorcontrib>Toth, Gabor</creatorcontrib><creatorcontrib>Hua, Fei</creatorcontrib><creatorcontrib>Comer, Gail M</creatorcontrib><creatorcontrib>Hinz, Michelle</creatorcontrib><creatorcontrib>Page, Karen</creatorcontrib><creatorcontrib>O'Toole, Margot</creatorcontrib><creatorcontrib>Moorehead, Tara McDonnell</creatorcontrib><creatorcontrib>Zhu, Hua</creatorcontrib><creatorcontrib>Sun, YanHui</creatorcontrib><creatorcontrib>Cataldi, Fabio</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 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Abstracts</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reinisch, Walter</au><au>Panés, Julián</au><au>Khurana, Sunil</au><au>Toth, Gabor</au><au>Hua, Fei</au><au>Comer, Gail M</au><au>Hinz, Michelle</au><au>Page, Karen</au><au>O'Toole, Margot</au><au>Moorehead, Tara McDonnell</au><au>Zhu, Hua</au><au>Sun, YanHui</au><au>Cataldi, Fabio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2015-06-01</date><risdate>2015</risdate><volume>64</volume><issue>6</issue><spage>894</spage><epage>900</epage><pages>894-900</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><coden>GUTTAK</coden><abstract>Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels. Results The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups. Conclusions A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13. Trial registration number ClinicalTrials.gov number NCT01284062.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>25567115</pmid><doi>10.1136/gutjnl-2014-308337</doi><tpages>7</tpages></addata></record> |
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| ispartof | Gut, 2015-06, Vol.64 (6), p.894-900 |
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| subjects | Administration, Intravenous Adolescent Adult Aged Analysis of Variance Antibodies, Monoclonal, Humanized - pharmacokinetics Antibodies, Monoclonal, Humanized - therapeutic use Biomarkers Biomarkers - blood Biopsy Clinical medicine Colitis, Ulcerative - blood Colitis, Ulcerative - drug therapy Colitis, Ulcerative - pathology Colon - pathology Crohn's disease Cytokines Dose-Response Relationship, Drug Double-Blind Method Endoscopy Eosinophils - cytology Eosinophils - drug effects Feces - chemistry Female Humans Immunosuppressive Agents - therapeutic use Interleukin-13 - antagonists & inhibitors Interleukin-13 - blood Leukocyte Count Leukocyte L1 Antigen Complex - analysis Male Middle Aged Molecular weight Remission Induction Rodents TNF inhibitors Treatment Outcome Tumor necrosis factor-TNF Young Adult |
| title | Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-20T13%3A23%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Anrukinzumab,%20an%20anti-interleukin%2013%20monoclonal%20antibody,%20in%20active%20UC:%20efficacy%20and%20safety%20from%20a%20phase%20IIa%20randomised%20multicentre%20study&rft.jtitle=Gut&rft.au=Reinisch,%20Walter&rft.date=2015-06-01&rft.volume=64&rft.issue=6&rft.spage=894&rft.epage=900&rft.pages=894-900&rft.issn=0017-5749&rft.eissn=1468-3288&rft.coden=GUTTAK&rft_id=info:doi/10.1136/gutjnl-2014-308337&rft_dat=%3Cproquest_cross%3E1808655030%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1779466131&rft_id=info:pmid/25567115&rfr_iscdi=true |