{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:12:18Z","timestamp":1787019138799,"version":"build-2736575974"},"reference-count":28,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>High-efficacy multiple sclerosis disease-modifying therapies (MS-DMTs) are associated with heightened immunosuppressive effects, potentially increasing the risk of infections. However, their association with human papillomavirus (HPV)-related conditions remains underexplored, particularly for newer treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate a signal of disproportionate reporting HPV-related conditions in women with MS-DMTs using real-world pharmacovigilance data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Individual case safety reports (ICSRs) from Vigibase\u00ae, the WHO global pharmacovigilance database, were analysed for MS-DMTs from 1 January 2000 to 31 December 2023. Disproportionality analysis was performed to calculate adjusted reporting odds ratios (aRORs) and Bayesian information component (IC) with 95% confidence intervals (95% CIs), for HPV-related conditions associated with each MS-DMT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Among 418,182 ICSRs involving MS-DMTs, 1111 reported HPV-related conditions. Fingolimod showed the highest aROR of 3.50 (95% CIs\u2009=\u20092.95\u20134.16), followed by ocrelizumab (2.48 (1.83\u20133.31)) and natalizumab (1.63 (1.34\u20131.97)) compared to pegylated or non-pegylated interferon betas.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>This study identified a potential signal of disproportionate reporting of HPV-related conditions with fingolimod, ocrelizumab and natalizumab based on real-world pharmacovigilance data. These exploratory findings highlight the need for population-based pharmacoepidemiological studies to confirm the signal, while HPV vaccination and cancer screening remain key preventive measures for patients on MS-DMTs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251377411","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T09:39:34Z","timestamp":1759916374000},"page":"1452-1463","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Human papillomavirus\u2013related conditions in women with multiple sclerosis receiving disease-modifying therapies: A Pharmacovigilance disproportionality analysis from the WHO vigibase\u00ae"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-7422-6976","authenticated-orcid":false,"given":"Constance","family":"Bordet","sequence":"first","affiliation":[{"name":"Clinical Research Unit, AP-HP H\u00f4pital Kremlin Bic\u00eatre, Paris-Saclay University, Le Kremlin Bic\u00eatre, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ouma\u00efma","family":"Maachi","sequence":"additional","affiliation":[{"name":"Clinical Research Unit, AP-HP H\u00f4pital Kremlin Bic\u00eatre, Paris-Saclay University, Le Kremlin Bic\u00eatre, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Caroline","family":"Papeix","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Foundation Adolphe de Rothschild, Paris, France"},{"name":"Department of Neurology, Faculty of Medicine, Paris-Cit\u00e9 University, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1312-4811","authenticated-orcid":false,"given":"Pauline","family":"Laigo","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance, Assistance Publique-H\u00f4pitaux de Paris (AP-HP), Chu Henri Mondor, Creteil, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4777-5690","authenticated-orcid":false,"given":"Laure","family":"Thomas","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance, Assistance Publique-H\u00f4pitaux de Paris (AP-HP), Chu Henri Mondor, Creteil, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lamiae","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Clinical Research Unit, AP-HP H\u00f4pital Kremlin Bic\u00eatre, Paris-Saclay University, Le Kremlin Bic\u00eatre, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,10,8]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.02954"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2020.05.049"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-021-01073-y"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurol.2021.02.066"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2019.3365"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/jso.26687"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(19)30482-6"},{"issue":"9","key":"e_1_3_2_9_2","first-page":"494","article-title":"Cervical dysplasia associated with the use of natalizumab","volume":"71","author":"Rolfes L","year":"2013","unstructured":"Rolfes L, Lokhorst B, Samijn J, et al Cervical dysplasia associated with the use of natalizumab. Neth J Med 2013; 71(9): 494\u2013495.","journal-title":"Neth J Med"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/fcp.12394"},{"issue":"1","key":"e_1_3_2_11_2","first-page":"28","article-title":"HPV-associated anal and genital intraepithelial neoplasia after using fingolimod in the treatment of relapsing-remitting multiple sclerosis: A case report","volume":"2","author":"Ocalan M","year":"2022","unstructured":"Ocalan M, Morkavuk G, Gursoy A, et al HPV-associated anal and genital intraepithelial neoplasia after using fingolimod in the treatment of relapsing-remitting multiple sclerosis: A case report. J Mult Scler Res 2022; 2(1): 28\u201330.","journal-title":"J Mult Scler Res"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458518807088"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458518813109"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000208059"},{"key":"e_1_3_2_15_2","first-page":"1424","volume-title":"Mult Scler","volume":"28","author":"Tur C","year":"2022","unstructured":"Tur C, Dubessy AL, Otero-Romero S, et al The risk of infections for multiple sclerosis and neuromyelitis optica spectrum disorder disease-modifying treatments: Eighth European committee for treatment and research in multiple sclerosis focused workshop review. 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