Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study

Summary Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real‐life long‐term data are currently available. Aims To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods From January to Septem...

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Veröffentlicht in:Alimentary pharmacology & therapeutics 2021-10, Vol.54 (7), p.944-951
Hauptverfasser: Fumery, Mathurin, Filippi, Jérôme, Abitbol, Vered, Biron, Amélie, Laharie, David, Serrero, Melanie, Altwegg, Romain, Bouhnik, Yoram, Peyrin‐Biroulet, Laurent, Gilletta, Cyrielle, Roblin, Xavier, Pineton de Chambrun, Guillaume, Vuitton, Lucine, Bourrier, Anne, Nancey, Stephane, Gornet, Jean‐Marc, Nahon, Stephane, Bouguen, Guillaume, Viennot, Stephanie, Nachury, Maria, Amiot, Aurelien, Brazier, Franck, Yzet, Clara, Hebuterne, Xavier, Cadiot, Guillaume, Brixi, Hedia, Rivière, Pauline, Poullenot, Florian, Treton, Xavier, Stefanescu, Carmen, Zallot, Camille, Beaugerie, Laurent, Seksik, Philippe, Sokol, Harry, Kirchgesner, Julien, Boschetti, Gilles, Flourié, Bernard, Gay, Claire, Danion, Pauline, Venturin, Chloe, Allez, Matthieu, Baudry, Clotilde, Pariente, Benjamin, Wils, Pauline, Gagnière, Charlotte, Tannoury, Jenny
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container_issue 7
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container_title Alimentary pharmacology & therapeutics
container_volume 54
creator Fumery, Mathurin
Filippi, Jérôme
Abitbol, Vered
Biron, Amélie
Laharie, David
Serrero, Melanie
Altwegg, Romain
Bouhnik, Yoram
Peyrin‐Biroulet, Laurent
Gilletta, Cyrielle
Roblin, Xavier
Pineton de Chambrun, Guillaume
Vuitton, Lucine
Bourrier, Anne
Nancey, Stephane
Gornet, Jean‐Marc
Nahon, Stephane
Bouguen, Guillaume
Viennot, Stephanie
Nachury, Maria
Amiot, Aurelien
Brazier, Franck
Yzet, Clara
Hebuterne, Xavier
Cadiot, Guillaume
Brixi, Hedia
Rivière, Pauline
Poullenot, Florian
Treton, Xavier
Stefanescu, Carmen
Zallot, Camille
Beaugerie, Laurent
Seksik, Philippe
Sokol, Harry
Kirchgesner, Julien
Boschetti, Gilles
Flourié, Bernard
Gay, Claire
Danion, Pauline
Venturin, Chloe
Allez, Matthieu
Baudry, Clotilde
Pariente, Benjamin
Wils, Pauline
Gagnière, Charlotte
Tannoury, Jenny
description Summary Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real‐life long‐term data are currently available. Aims To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti‐TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid‐free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3‐10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one‐half of patients with refractory UC were still treated by ustekinumab and one‐third were in steroid‐free clinical remission. Among 103 patients with ulcerative colitis treated with ustekinumab, one‐third achieved steroid‐free clinical remission and less than 10% were referred to surgery, after a 1‐year follow‐up period. https://doi.org/10.1111/apt.16544
doi_str_mv 10.1111/apt.16544
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Aims To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti‐TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid‐free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3‐10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one‐half of patients with refractory UC were still treated by ustekinumab and one‐third were in steroid‐free clinical remission. Among 103 patients with ulcerative colitis treated with ustekinumab, one‐third achieved steroid‐free clinical remission and less than 10% were referred to surgery, after a 1‐year follow‐up period. https://doi.org/10.1111/apt.16544</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>EISSN: 0269-2813</identifier><identifier>DOI: 10.1111/apt.16544</identifier><identifier>PMID: 34296456</identifier><language>eng</language><publisher>Chichester: Wiley Subscription Services, Inc</publisher><subject>Adult ; Clinical trials ; Cohort analysis ; Cohort Studies ; Colitis, Ulcerative ; Colorectal surgery ; Human health and pathology ; Humans ; Hépatology and Gastroenterology ; Immunosuppressive agents ; Inflammatory bowel disease ; Life Sciences ; Male ; Middle Aged ; Myocardial infarction ; Patients ; Pharmaceutical sciences ; Pharmacology ; Remission ; Remission (Medicine) ; Remission Induction ; Safety ; Steroids ; Treatment Outcome ; Ulcerative colitis ; Ustekinumab</subject><ispartof>Alimentary pharmacology &amp; therapeutics, 2021-10, Vol.54 (7), p.944-951</ispartof><rights>2021 John Wiley &amp; Sons Ltd</rights><rights>Copyright © 2021 John Wiley &amp; Sons Ltd</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3644-1476800e1cc7396b32da5f797854165692594344754910aed64390a13b5809413</citedby><cites>FETCH-LOGICAL-c3644-1476800e1cc7396b32da5f797854165692594344754910aed64390a13b5809413</cites><orcidid>0000-0003-2536-6618 ; 0000-0001-6676-1222 ; 0000-0002-2337-2902 ; 0000-0002-4753-6676 ; 0000-0002-7929-4878 ; 0000-0001-9845-6572 ; 0000-0002-7444-5905 ; 0000-0003-2088-1442 ; 0000-0002-5787-4943 ; 0000-0002-2840-0108</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.16544$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.16544$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://hal.science/hal-03336375$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Fumery, Mathurin</creatorcontrib><creatorcontrib>Filippi, Jérôme</creatorcontrib><creatorcontrib>Abitbol, Vered</creatorcontrib><creatorcontrib>Biron, Amélie</creatorcontrib><creatorcontrib>Laharie, David</creatorcontrib><creatorcontrib>Serrero, Melanie</creatorcontrib><creatorcontrib>Altwegg, Romain</creatorcontrib><creatorcontrib>Bouhnik, Yoram</creatorcontrib><creatorcontrib>Peyrin‐Biroulet, Laurent</creatorcontrib><creatorcontrib>Gilletta, Cyrielle</creatorcontrib><creatorcontrib>Roblin, Xavier</creatorcontrib><creatorcontrib>Pineton de Chambrun, Guillaume</creatorcontrib><creatorcontrib>Vuitton, Lucine</creatorcontrib><creatorcontrib>Bourrier, Anne</creatorcontrib><creatorcontrib>Nancey, Stephane</creatorcontrib><creatorcontrib>Gornet, Jean‐Marc</creatorcontrib><creatorcontrib>Nahon, Stephane</creatorcontrib><creatorcontrib>Bouguen, Guillaume</creatorcontrib><creatorcontrib>Viennot, Stephanie</creatorcontrib><creatorcontrib>Nachury, Maria</creatorcontrib><creatorcontrib>Amiot, Aurelien</creatorcontrib><creatorcontrib>Brazier, Franck</creatorcontrib><creatorcontrib>Yzet, Clara</creatorcontrib><creatorcontrib>Hebuterne, Xavier</creatorcontrib><creatorcontrib>Cadiot, Guillaume</creatorcontrib><creatorcontrib>Brixi, Hedia</creatorcontrib><creatorcontrib>Rivière, Pauline</creatorcontrib><creatorcontrib>Poullenot, Florian</creatorcontrib><creatorcontrib>Treton, Xavier</creatorcontrib><creatorcontrib>Stefanescu, Carmen</creatorcontrib><creatorcontrib>Zallot, Camille</creatorcontrib><creatorcontrib>Beaugerie, Laurent</creatorcontrib><creatorcontrib>Seksik, Philippe</creatorcontrib><creatorcontrib>Sokol, Harry</creatorcontrib><creatorcontrib>Kirchgesner, Julien</creatorcontrib><creatorcontrib>Boschetti, Gilles</creatorcontrib><creatorcontrib>Flourié, Bernard</creatorcontrib><creatorcontrib>Gay, Claire</creatorcontrib><creatorcontrib>Danion, Pauline</creatorcontrib><creatorcontrib>Venturin, Chloe</creatorcontrib><creatorcontrib>Allez, Matthieu</creatorcontrib><creatorcontrib>Baudry, Clotilde</creatorcontrib><creatorcontrib>Pariente, Benjamin</creatorcontrib><creatorcontrib>Wils, Pauline</creatorcontrib><creatorcontrib>Gagnière, Charlotte</creatorcontrib><creatorcontrib>Tannoury, Jenny</creatorcontrib><title>Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study</title><title>Alimentary pharmacology &amp; therapeutics</title><description>Summary Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real‐life long‐term data are currently available. Aims To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti‐TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid‐free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3‐10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one‐half of patients with refractory UC were still treated by ustekinumab and one‐third were in steroid‐free clinical remission. Among 103 patients with ulcerative colitis treated with ustekinumab, one‐third achieved steroid‐free clinical remission and less than 10% were referred to surgery, after a 1‐year follow‐up period. https://doi.org/10.1111/apt.16544</description><subject>Adult</subject><subject>Clinical trials</subject><subject>Cohort analysis</subject><subject>Cohort Studies</subject><subject>Colitis, Ulcerative</subject><subject>Colorectal surgery</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Hépatology and Gastroenterology</subject><subject>Immunosuppressive agents</subject><subject>Inflammatory bowel disease</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Patients</subject><subject>Pharmaceutical sciences</subject><subject>Pharmacology</subject><subject>Remission</subject><subject>Remission (Medicine)</subject><subject>Remission Induction</subject><subject>Safety</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><subject>Ulcerative colitis</subject><subject>Ustekinumab</subject><issn>0269-2813</issn><issn>1365-2036</issn><issn>0269-2813</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kU1rGzEQhkVpaZy0h_4DQS_tYRN9r9WbSdwkYEgO7lmM5VmsdK3drrQJ219fOS4NBDqXgZln5p3hJeQTZ-e8xAX0-ZwbrdQbMuPS6Eowad6SGRPGVmLO5Qk5TemBMWZqJt6TE6mENUqbGfm9bBr0OTxixJQoxC1N0GCeaNfQMWX8GeK4hw3dQ4gZI0SPNO9wgH6iIVLOJO0hB4w50aeQd3RsfekeNlLftSGH9I0CvV6uF7dXpbLrhkxTHrfTB_KugTbhx7_5jPz4vlxf3lSru-vby8Wq8tIoVXFVmzljyL2vpTUbKbagm9rWc63K08YKbZVUqtbKcga4NUpaBlxu9JxZxeUZ-Xrcu4PW9UPYwzC5DoK7WazcocaklEbW-vHAfjmy_dD9GjFltw_JY9tCxG5MTmitOdNCqIJ-foU-dOMQyyeFqostRV6_iPuhS2nA5t8FnLmDea6Y557NK-zFkX0KLU7_B93ifn2c-AOCjpYr</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Fumery, Mathurin</creator><creator>Filippi, Jérôme</creator><creator>Abitbol, Vered</creator><creator>Biron, Amélie</creator><creator>Laharie, David</creator><creator>Serrero, Melanie</creator><creator>Altwegg, Romain</creator><creator>Bouhnik, Yoram</creator><creator>Peyrin‐Biroulet, Laurent</creator><creator>Gilletta, Cyrielle</creator><creator>Roblin, Xavier</creator><creator>Pineton de Chambrun, Guillaume</creator><creator>Vuitton, Lucine</creator><creator>Bourrier, Anne</creator><creator>Nancey, Stephane</creator><creator>Gornet, Jean‐Marc</creator><creator>Nahon, Stephane</creator><creator>Bouguen, Guillaume</creator><creator>Viennot, Stephanie</creator><creator>Nachury, Maria</creator><creator>Amiot, Aurelien</creator><creator>Brazier, Franck</creator><creator>Yzet, Clara</creator><creator>Hebuterne, Xavier</creator><creator>Cadiot, Guillaume</creator><creator>Brixi, Hedia</creator><creator>Rivière, Pauline</creator><creator>Poullenot, Florian</creator><creator>Treton, Xavier</creator><creator>Stefanescu, Carmen</creator><creator>Zallot, Camille</creator><creator>Beaugerie, Laurent</creator><creator>Seksik, Philippe</creator><creator>Sokol, Harry</creator><creator>Kirchgesner, Julien</creator><creator>Boschetti, Gilles</creator><creator>Flourié, Bernard</creator><creator>Gay, Claire</creator><creator>Danion, Pauline</creator><creator>Venturin, Chloe</creator><creator>Allez, Matthieu</creator><creator>Baudry, Clotilde</creator><creator>Pariente, Benjamin</creator><creator>Wils, Pauline</creator><creator>Gagnière, Charlotte</creator><creator>Tannoury, Jenny</creator><general>Wiley Subscription Services, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0003-2536-6618</orcidid><orcidid>https://orcid.org/0000-0001-6676-1222</orcidid><orcidid>https://orcid.org/0000-0002-2337-2902</orcidid><orcidid>https://orcid.org/0000-0002-4753-6676</orcidid><orcidid>https://orcid.org/0000-0002-7929-4878</orcidid><orcidid>https://orcid.org/0000-0001-9845-6572</orcidid><orcidid>https://orcid.org/0000-0002-7444-5905</orcidid><orcidid>https://orcid.org/0000-0003-2088-1442</orcidid><orcidid>https://orcid.org/0000-0002-5787-4943</orcidid><orcidid>https://orcid.org/0000-0002-2840-0108</orcidid></search><sort><creationdate>202110</creationdate><title>Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study</title><author>Fumery, Mathurin ; Filippi, Jérôme ; Abitbol, Vered ; Biron, Amélie ; Laharie, David ; Serrero, Melanie ; Altwegg, Romain ; Bouhnik, Yoram ; Peyrin‐Biroulet, Laurent ; Gilletta, Cyrielle ; Roblin, Xavier ; Pineton de Chambrun, Guillaume ; Vuitton, Lucine ; Bourrier, Anne ; Nancey, Stephane ; Gornet, Jean‐Marc ; Nahon, Stephane ; Bouguen, Guillaume ; Viennot, Stephanie ; Nachury, Maria ; Amiot, Aurelien ; Brazier, Franck ; Yzet, Clara ; Hebuterne, Xavier ; Cadiot, Guillaume ; Brixi, Hedia ; Rivière, Pauline ; Poullenot, Florian ; Treton, Xavier ; Stefanescu, Carmen ; Zallot, Camille ; Beaugerie, Laurent ; Seksik, Philippe ; Sokol, Harry ; Kirchgesner, Julien ; Boschetti, Gilles ; Flourié, Bernard ; Gay, Claire ; Danion, Pauline ; Venturin, Chloe ; Allez, Matthieu ; Baudry, Clotilde ; Pariente, Benjamin ; Wils, Pauline ; Gagnière, Charlotte ; Tannoury, Jenny</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3644-1476800e1cc7396b32da5f797854165692594344754910aed64390a13b5809413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Clinical trials</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Colitis, Ulcerative</topic><topic>Colorectal surgery</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Hépatology and Gastroenterology</topic><topic>Immunosuppressive agents</topic><topic>Inflammatory bowel disease</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>Patients</topic><topic>Pharmaceutical sciences</topic><topic>Pharmacology</topic><topic>Remission</topic><topic>Remission (Medicine)</topic><topic>Remission Induction</topic><topic>Safety</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><topic>Ulcerative colitis</topic><topic>Ustekinumab</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fumery, Mathurin</creatorcontrib><creatorcontrib>Filippi, Jérôme</creatorcontrib><creatorcontrib>Abitbol, Vered</creatorcontrib><creatorcontrib>Biron, Amélie</creatorcontrib><creatorcontrib>Laharie, David</creatorcontrib><creatorcontrib>Serrero, Melanie</creatorcontrib><creatorcontrib>Altwegg, Romain</creatorcontrib><creatorcontrib>Bouhnik, Yoram</creatorcontrib><creatorcontrib>Peyrin‐Biroulet, Laurent</creatorcontrib><creatorcontrib>Gilletta, Cyrielle</creatorcontrib><creatorcontrib>Roblin, Xavier</creatorcontrib><creatorcontrib>Pineton de Chambrun, Guillaume</creatorcontrib><creatorcontrib>Vuitton, Lucine</creatorcontrib><creatorcontrib>Bourrier, Anne</creatorcontrib><creatorcontrib>Nancey, Stephane</creatorcontrib><creatorcontrib>Gornet, Jean‐Marc</creatorcontrib><creatorcontrib>Nahon, Stephane</creatorcontrib><creatorcontrib>Bouguen, Guillaume</creatorcontrib><creatorcontrib>Viennot, Stephanie</creatorcontrib><creatorcontrib>Nachury, Maria</creatorcontrib><creatorcontrib>Amiot, Aurelien</creatorcontrib><creatorcontrib>Brazier, Franck</creatorcontrib><creatorcontrib>Yzet, Clara</creatorcontrib><creatorcontrib>Hebuterne, Xavier</creatorcontrib><creatorcontrib>Cadiot, Guillaume</creatorcontrib><creatorcontrib>Brixi, Hedia</creatorcontrib><creatorcontrib>Rivière, Pauline</creatorcontrib><creatorcontrib>Poullenot, Florian</creatorcontrib><creatorcontrib>Treton, Xavier</creatorcontrib><creatorcontrib>Stefanescu, Carmen</creatorcontrib><creatorcontrib>Zallot, Camille</creatorcontrib><creatorcontrib>Beaugerie, Laurent</creatorcontrib><creatorcontrib>Seksik, Philippe</creatorcontrib><creatorcontrib>Sokol, Harry</creatorcontrib><creatorcontrib>Kirchgesner, Julien</creatorcontrib><creatorcontrib>Boschetti, Gilles</creatorcontrib><creatorcontrib>Flourié, Bernard</creatorcontrib><creatorcontrib>Gay, Claire</creatorcontrib><creatorcontrib>Danion, Pauline</creatorcontrib><creatorcontrib>Venturin, Chloe</creatorcontrib><creatorcontrib>Allez, Matthieu</creatorcontrib><creatorcontrib>Baudry, Clotilde</creatorcontrib><creatorcontrib>Pariente, Benjamin</creatorcontrib><creatorcontrib>Wils, Pauline</creatorcontrib><creatorcontrib>Gagnière, Charlotte</creatorcontrib><creatorcontrib>Tannoury, Jenny</creatorcontrib><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fumery, Mathurin</au><au>Filippi, Jérôme</au><au>Abitbol, Vered</au><au>Biron, Amélie</au><au>Laharie, David</au><au>Serrero, Melanie</au><au>Altwegg, Romain</au><au>Bouhnik, Yoram</au><au>Peyrin‐Biroulet, Laurent</au><au>Gilletta, Cyrielle</au><au>Roblin, Xavier</au><au>Pineton de Chambrun, Guillaume</au><au>Vuitton, Lucine</au><au>Bourrier, Anne</au><au>Nancey, Stephane</au><au>Gornet, Jean‐Marc</au><au>Nahon, Stephane</au><au>Bouguen, Guillaume</au><au>Viennot, Stephanie</au><au>Nachury, Maria</au><au>Amiot, Aurelien</au><au>Brazier, Franck</au><au>Yzet, Clara</au><au>Hebuterne, Xavier</au><au>Cadiot, Guillaume</au><au>Brixi, Hedia</au><au>Rivière, Pauline</au><au>Poullenot, Florian</au><au>Treton, Xavier</au><au>Stefanescu, Carmen</au><au>Zallot, Camille</au><au>Beaugerie, Laurent</au><au>Seksik, Philippe</au><au>Sokol, Harry</au><au>Kirchgesner, Julien</au><au>Boschetti, Gilles</au><au>Flourié, Bernard</au><au>Gay, Claire</au><au>Danion, Pauline</au><au>Venturin, Chloe</au><au>Allez, Matthieu</au><au>Baudry, Clotilde</au><au>Pariente, Benjamin</au><au>Wils, Pauline</au><au>Gagnière, Charlotte</au><au>Tannoury, Jenny</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study</atitle><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle><date>2021-10</date><risdate>2021</risdate><volume>54</volume><issue>7</issue><spage>944</spage><epage>951</epage><pages>944-951</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><eissn>0269-2813</eissn><abstract>Summary Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real‐life long‐term data are currently available. Aims To assess the real‐world effectiveness and safety of ustekinumab in patients with UC. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined as a partial Mayo Clinic score ≤2. Results We included 103 patients with UC (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) with an insufficient response to immunosuppressants, anti‐TNFs and/or vedolizumab. At week 52, 45 (44%) patients had discontinued ustekinumab mainly due to lack of effectiveness (n = 41). The cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7% and 58.4% after 3, 6, 9 and 12 months respectively. The overall steroid‐free clinical remission rate at week 52 was 32% of whom 71% had subscores of null for rectal bleeding and stool frequency. Ten patients underwent colectomy within a median of 6.7 [4.3‐10.6] months. Adverse effects were observed in 15 (16.9%) patients; 4 (4.5%) were severe, including one patient who died from a myocardial infarction. Conclusion After 52 weeks, over one‐half of patients with refractory UC were still treated by ustekinumab and one‐third were in steroid‐free clinical remission. Among 103 patients with ulcerative colitis treated with ustekinumab, one‐third achieved steroid‐free clinical remission and less than 10% were referred to surgery, after a 1‐year follow‐up period. https://doi.org/10.1111/apt.16544</abstract><cop>Chichester</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34296456</pmid><doi>10.1111/apt.16544</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-2536-6618</orcidid><orcidid>https://orcid.org/0000-0001-6676-1222</orcidid><orcidid>https://orcid.org/0000-0002-2337-2902</orcidid><orcidid>https://orcid.org/0000-0002-4753-6676</orcidid><orcidid>https://orcid.org/0000-0002-7929-4878</orcidid><orcidid>https://orcid.org/0000-0001-9845-6572</orcidid><orcidid>https://orcid.org/0000-0002-7444-5905</orcidid><orcidid>https://orcid.org/0000-0003-2088-1442</orcidid><orcidid>https://orcid.org/0000-0002-5787-4943</orcidid><orcidid>https://orcid.org/0000-0002-2840-0108</orcidid></addata></record>
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subjects Adult
Clinical trials
Cohort analysis
Cohort Studies
Colitis, Ulcerative
Colorectal surgery
Human health and pathology
Humans
Hépatology and Gastroenterology
Immunosuppressive agents
Inflammatory bowel disease
Life Sciences
Male
Middle Aged
Myocardial infarction
Patients
Pharmaceutical sciences
Pharmacology
Remission
Remission (Medicine)
Remission Induction
Safety
Steroids
Treatment Outcome
Ulcerative colitis
Ustekinumab
title Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study
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