Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance

Abstract Background Safety of HPV vaccines is still in question due to reports of autoimmune diseases (ADs) following HPV immunization. Objectives To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. Methods Systematic prospective case-referent stud...

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Veröffentlicht in:Journal of autoimmunity 2017-05, Vol.79, p.84-90
Hauptverfasser: Grimaldi-Bensouda, Lamiae, Rossignol, Michel, Koné-Paut, Isabelle, Krivitzky, Alain, Lebrun-Frenay, Christine, Clet, Johanna, Brassat, David, Papeix, Caroline, Nicolino, Marc, Benhamou, Pierre-Yves, Fain, Olivier, Costedoat-Chalumeau, Nathalie, Courcoux, Marie-France, Viallard, Jean-François, Godeau, Bertrand, Papo, Thomas, Vermersch, Patrick, Bourgault-Villada, Isabelle, Breart, Gerard, Abenhaim, Lucien
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container_end_page 90
container_issue
container_start_page 84
container_title Journal of autoimmunity
container_volume 79
creator Grimaldi-Bensouda, Lamiae
Rossignol, Michel
Koné-Paut, Isabelle
Krivitzky, Alain
Lebrun-Frenay, Christine
Clet, Johanna
Brassat, David
Papeix, Caroline
Nicolino, Marc
Benhamou, Pierre-Yves
Fain, Olivier
Costedoat-Chalumeau, Nathalie
Courcoux, Marie-France
Viallard, Jean-François
Godeau, Bertrand
Papo, Thomas
Vermersch, Patrick
Bourgault-Villada, Isabelle
Breart, Gerard
Abenhaim, Lucien
description Abstract Background Safety of HPV vaccines is still in question due to reports of autoimmune diseases (ADs) following HPV immunization. Objectives To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. Methods Systematic prospective case-referent study conducted to assess the risks associated with real-life use of HPV vaccines. Cases were female 11–25 years old with incident ADs [central demyelination/multiple sclerosis (CD/MS), connective tissue disease (CTD), Guillain-Barré syndrome (GBS), type-1 diabetes (T1D), autoimmune thyroiditis (AT), and idiopathic thrombocytopenic purpura (ITP)]. Cases were consecutively and prospectively identified at specialized centers across France (2008–2014) and individually matched by age and place of residence to referents recruited in general practice. Risk was computed using multivariate conditional logistic regression models adjusted for family history of ADs, living in France (north/south), co-medications and co-vaccinations. Results With a total of 478 definite cases matched to 1869 referents, all ADs combined were negatively associated to HPV vaccination with an adjusted odds ratio of 0.58 (95% confidence interval: 0.41–0.83). Similar results were obtained for CD/MS, AT, CT, and T1D, the last two not reaching statistical significance. No association was found for ITP and GBS. Sensitivity analyses combining definite and possible cases with secondary time window showed similar results. Conclusion Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. Continued active surveillance is needed to confirm this finding for individual ADs.
doi_str_mv 10.1016/j.jaut.2017.01.005
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Objectives To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. Methods Systematic prospective case-referent study conducted to assess the risks associated with real-life use of HPV vaccines. Cases were female 11–25 years old with incident ADs [central demyelination/multiple sclerosis (CD/MS), connective tissue disease (CTD), Guillain-Barré syndrome (GBS), type-1 diabetes (T1D), autoimmune thyroiditis (AT), and idiopathic thrombocytopenic purpura (ITP)]. Cases were consecutively and prospectively identified at specialized centers across France (2008–2014) and individually matched by age and place of residence to referents recruited in general practice. Risk was computed using multivariate conditional logistic regression models adjusted for family history of ADs, living in France (north/south), co-medications and co-vaccinations. Results With a total of 478 definite cases matched to 1869 referents, all ADs combined were negatively associated to HPV vaccination with an adjusted odds ratio of 0.58 (95% confidence interval: 0.41–0.83). Similar results were obtained for CD/MS, AT, CT, and T1D, the last two not reaching statistical significance. No association was found for ITP and GBS. Sensitivity analyses combining definite and possible cases with secondary time window showed similar results. Conclusion Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. Continued active surveillance is needed to confirm this finding for individual ADs.</description><identifier>ISSN: 0896-8411</identifier><identifier>EISSN: 1095-9157</identifier><identifier>DOI: 10.1016/j.jaut.2017.01.005</identifier><identifier>PMID: 28190705</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Allergy and Immunology ; Autoimmune disease ; Autoimmune Diseases - epidemiology ; Autoimmune Diseases - etiology ; Child ; Female ; Follow-Up Studies ; HPV vaccine ; Humans ; Immunology ; Life Sciences ; Male ; Odds Ratio ; Papillomavirus Infections - complications ; Papillomavirus Infections - prevention &amp; control ; Papillomavirus Vaccines - adverse effects ; Papillomavirus Vaccines - immunology ; Pharmacoepidemiology ; Population Surveillance ; Risk ; Santé publique et épidémiologie ; Vaccinology ; Young Adult</subject><ispartof>Journal of autoimmunity, 2017-05, Vol.79, p.84-90</ispartof><rights>The Authors</rights><rights>2017 The Authors</rights><rights>Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>Attribution - NonCommercial - NoDerivatives</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489t-c2f3eaf5bd96363674b130bb05e94968e8966fefaea2e064da24bb4633f682063</citedby><cites>FETCH-LOGICAL-c489t-c2f3eaf5bd96363674b130bb05e94968e8966fefaea2e064da24bb4633f682063</cites><orcidid>0000-0002-8531-9971 ; 0000-0003-0637-4778 ; 0000-0003-4074-6125 ; 0000-0002-1555-9021 ; 0000-0002-1974-3870 ; 0000-0003-0997-8817 ; 0000-0002-3713-2416 ; 0000-0001-6430-305X ; 0000-0003-4378-0468</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0896841116302141$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28190705$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-01783748$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Grimaldi-Bensouda, Lamiae</creatorcontrib><creatorcontrib>Rossignol, Michel</creatorcontrib><creatorcontrib>Koné-Paut, Isabelle</creatorcontrib><creatorcontrib>Krivitzky, Alain</creatorcontrib><creatorcontrib>Lebrun-Frenay, Christine</creatorcontrib><creatorcontrib>Clet, Johanna</creatorcontrib><creatorcontrib>Brassat, David</creatorcontrib><creatorcontrib>Papeix, Caroline</creatorcontrib><creatorcontrib>Nicolino, Marc</creatorcontrib><creatorcontrib>Benhamou, Pierre-Yves</creatorcontrib><creatorcontrib>Fain, Olivier</creatorcontrib><creatorcontrib>Costedoat-Chalumeau, Nathalie</creatorcontrib><creatorcontrib>Courcoux, Marie-France</creatorcontrib><creatorcontrib>Viallard, Jean-François</creatorcontrib><creatorcontrib>Godeau, Bertrand</creatorcontrib><creatorcontrib>Papo, Thomas</creatorcontrib><creatorcontrib>Vermersch, Patrick</creatorcontrib><creatorcontrib>Bourgault-Villada, Isabelle</creatorcontrib><creatorcontrib>Breart, Gerard</creatorcontrib><creatorcontrib>Abenhaim, Lucien</creatorcontrib><creatorcontrib>the PGRx-AD Study Group</creatorcontrib><creatorcontrib>PGRx-AD Study Group</creatorcontrib><title>Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance</title><title>Journal of autoimmunity</title><addtitle>J Autoimmun</addtitle><description>Abstract Background Safety of HPV vaccines is still in question due to reports of autoimmune diseases (ADs) following HPV immunization. Objectives To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. Methods Systematic prospective case-referent study conducted to assess the risks associated with real-life use of HPV vaccines. Cases were female 11–25 years old with incident ADs [central demyelination/multiple sclerosis (CD/MS), connective tissue disease (CTD), Guillain-Barré syndrome (GBS), type-1 diabetes (T1D), autoimmune thyroiditis (AT), and idiopathic thrombocytopenic purpura (ITP)]. Cases were consecutively and prospectively identified at specialized centers across France (2008–2014) and individually matched by age and place of residence to referents recruited in general practice. Risk was computed using multivariate conditional logistic regression models adjusted for family history of ADs, living in France (north/south), co-medications and co-vaccinations. Results With a total of 478 definite cases matched to 1869 referents, all ADs combined were negatively associated to HPV vaccination with an adjusted odds ratio of 0.58 (95% confidence interval: 0.41–0.83). Similar results were obtained for CD/MS, AT, CT, and T1D, the last two not reaching statistical significance. No association was found for ITP and GBS. Sensitivity analyses combining definite and possible cases with secondary time window showed similar results. Conclusion Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. Continued active surveillance is needed to confirm this finding for individual ADs.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Allergy and Immunology</subject><subject>Autoimmune disease</subject><subject>Autoimmune Diseases - epidemiology</subject><subject>Autoimmune Diseases - etiology</subject><subject>Child</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>HPV vaccine</subject><subject>Humans</subject><subject>Immunology</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Odds Ratio</subject><subject>Papillomavirus Infections - complications</subject><subject>Papillomavirus Infections - prevention &amp; control</subject><subject>Papillomavirus Vaccines - adverse effects</subject><subject>Papillomavirus Vaccines - immunology</subject><subject>Pharmacoepidemiology</subject><subject>Population Surveillance</subject><subject>Risk</subject><subject>Santé publique et épidémiologie</subject><subject>Vaccinology</subject><subject>Young Adult</subject><issn>0896-8411</issn><issn>1095-9157</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ks1u1DAUhS0EokPhBVggL9tFgm-cOA5CSFUFDNJIIApsLce5UT3Nz9Q3iZi3x9GULlggLyxZ53z2PceMvQaRggD1dp_u7TylmYAyFZAKUTxhGxBVkVRQlE_ZRuhKJToHOGMviPZCABRF8ZydZRoqUYpiw_rvnu742PJIGn3fzwPyxhNaQuJ2aPjt3NuBH-zBd93YW774MBO_2H77dckX65wfkN7xG_-bH9EGWlEumpOALQYcJk5zWDCa7eDwJXvW2o7w1cN-zn5--vjjepvsvn7-cn21S1yuqylxWSvRtkXdVErGVeY1SFHXosAqr5TGOJdqsbVoMxQqb2yW13WupGyVzoSS5-zyxL21nTkE39twNKP1Znu1M-tZjEzLMtcLRO3FSXsI4_2MNJnek8P1wTjOZECrstKg5SrNTlIXRqI44SMbhFkrMXuzVmLWSuIdJlYSTW8e-HPdY_No-dtBFLw_CTAmsngMhpzHmFbjA7rJNKP_P__DP3bX-cE7293hEWk_zmGIWRswlBlhbtZPsf4JUFJkkIP8A5G_sX0</recordid><startdate>20170501</startdate><enddate>20170501</enddate><creator>Grimaldi-Bensouda, Lamiae</creator><creator>Rossignol, Michel</creator><creator>Koné-Paut, Isabelle</creator><creator>Krivitzky, Alain</creator><creator>Lebrun-Frenay, Christine</creator><creator>Clet, Johanna</creator><creator>Brassat, David</creator><creator>Papeix, Caroline</creator><creator>Nicolino, Marc</creator><creator>Benhamou, Pierre-Yves</creator><creator>Fain, Olivier</creator><creator>Costedoat-Chalumeau, Nathalie</creator><creator>Courcoux, Marie-France</creator><creator>Viallard, Jean-François</creator><creator>Godeau, Bertrand</creator><creator>Papo, Thomas</creator><creator>Vermersch, Patrick</creator><creator>Bourgault-Villada, Isabelle</creator><creator>Breart, Gerard</creator><creator>Abenhaim, Lucien</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><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>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0002-8531-9971</orcidid><orcidid>https://orcid.org/0000-0003-0637-4778</orcidid><orcidid>https://orcid.org/0000-0003-4074-6125</orcidid><orcidid>https://orcid.org/0000-0002-1555-9021</orcidid><orcidid>https://orcid.org/0000-0002-1974-3870</orcidid><orcidid>https://orcid.org/0000-0003-0997-8817</orcidid><orcidid>https://orcid.org/0000-0002-3713-2416</orcidid><orcidid>https://orcid.org/0000-0001-6430-305X</orcidid><orcidid>https://orcid.org/0000-0003-4378-0468</orcidid></search><sort><creationdate>20170501</creationdate><title>Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance</title><author>Grimaldi-Bensouda, Lamiae ; 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Objectives To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. Methods Systematic prospective case-referent study conducted to assess the risks associated with real-life use of HPV vaccines. Cases were female 11–25 years old with incident ADs [central demyelination/multiple sclerosis (CD/MS), connective tissue disease (CTD), Guillain-Barré syndrome (GBS), type-1 diabetes (T1D), autoimmune thyroiditis (AT), and idiopathic thrombocytopenic purpura (ITP)]. Cases were consecutively and prospectively identified at specialized centers across France (2008–2014) and individually matched by age and place of residence to referents recruited in general practice. Risk was computed using multivariate conditional logistic regression models adjusted for family history of ADs, living in France (north/south), co-medications and co-vaccinations. Results With a total of 478 definite cases matched to 1869 referents, all ADs combined were negatively associated to HPV vaccination with an adjusted odds ratio of 0.58 (95% confidence interval: 0.41–0.83). Similar results were obtained for CD/MS, AT, CT, and T1D, the last two not reaching statistical significance. No association was found for ITP and GBS. Sensitivity analyses combining definite and possible cases with secondary time window showed similar results. Conclusion Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. 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source MEDLINE; Elsevier ScienceDirect Journals
subjects Adolescent
Adult
Allergy and Immunology
Autoimmune disease
Autoimmune Diseases - epidemiology
Autoimmune Diseases - etiology
Child
Female
Follow-Up Studies
HPV vaccine
Humans
Immunology
Life Sciences
Male
Odds Ratio
Papillomavirus Infections - complications
Papillomavirus Infections - prevention & control
Papillomavirus Vaccines - adverse effects
Papillomavirus Vaccines - immunology
Pharmacoepidemiology
Population Surveillance
Risk
Santé publique et épidémiologie
Vaccinology
Young Adult
title Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance
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