Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey

Abstract Introduction Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns, and the side effect profile...

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Veröffentlicht in:Journal of Crohn's and colitis 2022-08, Vol.16 (7), p.1070-1078
Hauptverfasser: Ellul, Pierre, Revés, Joana, Abreu, Bárbara, Chaparro, María, Gisbert, Javier P, Allocca, Mariangela, Fiorino, Gionata, Barberio, Brigida, Zingone, Fabiana, Pisani, Anthea, Cassar, David, Michalopoulos, George, Mantzaris, Gerassimos, Koutroubakis, Ioannis, Karmiris, Konstantinos, Katsanos, Konstantinos, Ďuricova, Dana, Burisch, Johan, Madsen, Gorm Roager, Maaser, Christian, Naila, Arebi, Orfanoudaki, Eleni, Milivojevic, Vladimir, Buisson, Anthony, Avedano, Luisa, Leone, Salvo, Torres, Joana
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container_end_page 1078
container_issue 7
container_start_page 1070
container_title Journal of Crohn's and colitis
container_volume 16
creator Ellul, Pierre
Revés, Joana
Abreu, Bárbara
Chaparro, María
Gisbert, Javier P
Allocca, Mariangela
Fiorino, Gionata
Barberio, Brigida
Zingone, Fabiana
Pisani, Anthea
Cassar, David
Michalopoulos, George
Mantzaris, Gerassimos
Koutroubakis, Ioannis
Karmiris, Konstantinos
Katsanos, Konstantinos
Ďuricova, Dana
Burisch, Johan
Madsen, Gorm Roager
Maaser, Christian
Naila, Arebi
Orfanoudaki, Eleni
Milivojevic, Vladimir
Buisson, Anthony
Avedano, Luisa
Leone, Salvo
Torres, Joana
description Abstract Introduction Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. Methods An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. Results In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p 
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We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. Methods An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. Results In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p &lt; 0.001]. Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. Conclusions Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.</description><identifier>ISSN: 1873-9946</identifier><identifier>EISSN: 1876-4479</identifier><identifier>DOI: 10.1093/ecco-jcc/jjac010</identifier><identifier>PMID: 35037033</identifier><language>eng</language><publisher>UK: Oxford University Press</publisher><subject>Human health and pathology ; Hépatology and Gastroenterology ; Life Sciences ; Original</subject><ispartof>Journal of Crohn's and colitis, 2022-08, Vol.16 (7), p.1070-1078</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com 2022</rights><rights>The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-bea98a724d679b80a25ca6d0826d23da69b10995398f00b7a648917672d8aabf3</citedby><cites>FETCH-LOGICAL-c466t-bea98a724d679b80a25ca6d0826d23da69b10995398f00b7a648917672d8aabf3</cites><orcidid>0000-0002-9275-4242 ; 0000-0001-5623-2968</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35037033$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.inrae.fr/hal-03745073$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Ellul, Pierre</creatorcontrib><creatorcontrib>Revés, Joana</creatorcontrib><creatorcontrib>Abreu, Bárbara</creatorcontrib><creatorcontrib>Chaparro, María</creatorcontrib><creatorcontrib>Gisbert, Javier P</creatorcontrib><creatorcontrib>Allocca, Mariangela</creatorcontrib><creatorcontrib>Fiorino, Gionata</creatorcontrib><creatorcontrib>Barberio, Brigida</creatorcontrib><creatorcontrib>Zingone, Fabiana</creatorcontrib><creatorcontrib>Pisani, Anthea</creatorcontrib><creatorcontrib>Cassar, David</creatorcontrib><creatorcontrib>Michalopoulos, George</creatorcontrib><creatorcontrib>Mantzaris, Gerassimos</creatorcontrib><creatorcontrib>Koutroubakis, Ioannis</creatorcontrib><creatorcontrib>Karmiris, Konstantinos</creatorcontrib><creatorcontrib>Katsanos, Konstantinos</creatorcontrib><creatorcontrib>Ďuricova, Dana</creatorcontrib><creatorcontrib>Burisch, Johan</creatorcontrib><creatorcontrib>Madsen, Gorm Roager</creatorcontrib><creatorcontrib>Maaser, Christian</creatorcontrib><creatorcontrib>Naila, Arebi</creatorcontrib><creatorcontrib>Orfanoudaki, Eleni</creatorcontrib><creatorcontrib>Milivojevic, Vladimir</creatorcontrib><creatorcontrib>Buisson, Anthony</creatorcontrib><creatorcontrib>Avedano, Luisa</creatorcontrib><creatorcontrib>Leone, Salvo</creatorcontrib><creatorcontrib>Torres, Joana</creatorcontrib><title>Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey</title><title>Journal of Crohn's and colitis</title><addtitle>J Crohns Colitis</addtitle><description>Abstract Introduction Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. Methods An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. Results In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p &lt; 0.001]. Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. Conclusions Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.</description><subject>Human health and pathology</subject><subject>Hépatology and Gastroenterology</subject><subject>Life Sciences</subject><subject>Original</subject><issn>1873-9946</issn><issn>1876-4479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNptkc1u1DAURiMEoqWwZ4W8BCFTJ078wwIpTAsdaSQQA2Vp3TgOk1FiD3aSal6DJ8bpDFVBrGzZ555r3y9JnqfkTUokPTdaO7zV-ny7BU1S8iA5TQVnOM-5fHi7p1jKnJ0kT0LYElLIgovHyQktCOWE0tPk17LfdaY3doChdRaBrdF64_yAB-N7VNaT8cGgyykSAbkGlXZo8br8ssYLd40zdA1at9YE1Fq0tE0HfQ-D83v03t2YDl20wUAUfI76WfE2CiIX5fa2IXTou6lwFZnYePST2T9NHjXQBfPsuJ4l3z5cfl1c4dWnj8tFucI6Z2zAlQEpgGd5zbisBIGs0MBqIjJWZ7QGJqs4I1lQKRpCKg4sFzLljGe1AKgaepa8O3h3Y9WbWsfneejUzrc9-L1y0Kq_b2y7UT_cpIQgnJIiCl4dBJt_yq7KlZrP4pDzIrJTGtmXx2be_RxNGFTfBm26DqxxY1AZywgXjJAZJQdUexeCN82dOyVqjl3NsasYuzrGHkte3P_KXcGfnCPw-gC4cfdfHb6v-w10r7uC</recordid><startdate>20220804</startdate><enddate>20220804</enddate><creator>Ellul, Pierre</creator><creator>Revés, Joana</creator><creator>Abreu, Bárbara</creator><creator>Chaparro, María</creator><creator>Gisbert, Javier P</creator><creator>Allocca, Mariangela</creator><creator>Fiorino, Gionata</creator><creator>Barberio, Brigida</creator><creator>Zingone, Fabiana</creator><creator>Pisani, Anthea</creator><creator>Cassar, David</creator><creator>Michalopoulos, George</creator><creator>Mantzaris, Gerassimos</creator><creator>Koutroubakis, Ioannis</creator><creator>Karmiris, Konstantinos</creator><creator>Katsanos, Konstantinos</creator><creator>Ďuricova, Dana</creator><creator>Burisch, Johan</creator><creator>Madsen, Gorm Roager</creator><creator>Maaser, Christian</creator><creator>Naila, Arebi</creator><creator>Orfanoudaki, Eleni</creator><creator>Milivojevic, Vladimir</creator><creator>Buisson, Anthony</creator><creator>Avedano, Luisa</creator><creator>Leone, Salvo</creator><creator>Torres, Joana</creator><general>Oxford University Press</general><general>Elsevier - Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9275-4242</orcidid><orcidid>https://orcid.org/0000-0001-5623-2968</orcidid></search><sort><creationdate>20220804</creationdate><title>Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey</title><author>Ellul, Pierre ; Revés, Joana ; Abreu, Bárbara ; Chaparro, María ; Gisbert, Javier P ; Allocca, Mariangela ; Fiorino, Gionata ; Barberio, Brigida ; Zingone, Fabiana ; Pisani, Anthea ; Cassar, David ; Michalopoulos, George ; Mantzaris, Gerassimos ; Koutroubakis, Ioannis ; Karmiris, Konstantinos ; Katsanos, Konstantinos ; Ďuricova, Dana ; Burisch, Johan ; Madsen, Gorm Roager ; Maaser, Christian ; Naila, Arebi ; Orfanoudaki, Eleni ; Milivojevic, Vladimir ; Buisson, Anthony ; Avedano, Luisa ; Leone, Salvo ; Torres, Joana</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-bea98a724d679b80a25ca6d0826d23da69b10995398f00b7a648917672d8aabf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Human health and pathology</topic><topic>Hépatology and Gastroenterology</topic><topic>Life Sciences</topic><topic>Original</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ellul, Pierre</creatorcontrib><creatorcontrib>Revés, Joana</creatorcontrib><creatorcontrib>Abreu, Bárbara</creatorcontrib><creatorcontrib>Chaparro, María</creatorcontrib><creatorcontrib>Gisbert, Javier P</creatorcontrib><creatorcontrib>Allocca, Mariangela</creatorcontrib><creatorcontrib>Fiorino, Gionata</creatorcontrib><creatorcontrib>Barberio, Brigida</creatorcontrib><creatorcontrib>Zingone, Fabiana</creatorcontrib><creatorcontrib>Pisani, Anthea</creatorcontrib><creatorcontrib>Cassar, David</creatorcontrib><creatorcontrib>Michalopoulos, George</creatorcontrib><creatorcontrib>Mantzaris, Gerassimos</creatorcontrib><creatorcontrib>Koutroubakis, Ioannis</creatorcontrib><creatorcontrib>Karmiris, Konstantinos</creatorcontrib><creatorcontrib>Katsanos, Konstantinos</creatorcontrib><creatorcontrib>Ďuricova, Dana</creatorcontrib><creatorcontrib>Burisch, Johan</creatorcontrib><creatorcontrib>Madsen, Gorm Roager</creatorcontrib><creatorcontrib>Maaser, Christian</creatorcontrib><creatorcontrib>Naila, Arebi</creatorcontrib><creatorcontrib>Orfanoudaki, Eleni</creatorcontrib><creatorcontrib>Milivojevic, Vladimir</creatorcontrib><creatorcontrib>Buisson, Anthony</creatorcontrib><creatorcontrib>Avedano, Luisa</creatorcontrib><creatorcontrib>Leone, Salvo</creatorcontrib><creatorcontrib>Torres, Joana</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of Crohn's and colitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ellul, Pierre</au><au>Revés, Joana</au><au>Abreu, Bárbara</au><au>Chaparro, María</au><au>Gisbert, Javier P</au><au>Allocca, Mariangela</au><au>Fiorino, Gionata</au><au>Barberio, Brigida</au><au>Zingone, Fabiana</au><au>Pisani, Anthea</au><au>Cassar, David</au><au>Michalopoulos, George</au><au>Mantzaris, Gerassimos</au><au>Koutroubakis, Ioannis</au><au>Karmiris, Konstantinos</au><au>Katsanos, Konstantinos</au><au>Ďuricova, Dana</au><au>Burisch, Johan</au><au>Madsen, Gorm Roager</au><au>Maaser, Christian</au><au>Naila, Arebi</au><au>Orfanoudaki, Eleni</au><au>Milivojevic, Vladimir</au><au>Buisson, Anthony</au><au>Avedano, Luisa</au><au>Leone, Salvo</au><au>Torres, Joana</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey</atitle><jtitle>Journal of Crohn's and colitis</jtitle><addtitle>J Crohns Colitis</addtitle><date>2022-08-04</date><risdate>2022</risdate><volume>16</volume><issue>7</issue><spage>1070</spage><epage>1078</epage><pages>1070-1078</pages><issn>1873-9946</issn><eissn>1876-4479</eissn><abstract>Abstract Introduction Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. Methods An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. Results In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p &lt; 0.001]. Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. Conclusions Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.</abstract><cop>UK</cop><pub>Oxford University Press</pub><pmid>35037033</pmid><doi>10.1093/ecco-jcc/jjac010</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-9275-4242</orcidid><orcidid>https://orcid.org/0000-0001-5623-2968</orcidid><oa>free_for_read</oa></addata></record>
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subjects Human health and pathology
Hépatology and Gastroenterology
Life Sciences
Original
title Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey
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