| アブストラクト | BACKGROUND: 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. OBJECTIVE: To evaluate a signal of disproportionate reporting HPV-related conditions in women with MS-DMTs using real-world pharmacovigilance data. METHODS: Individual case safety reports (ICSRs) from Vigibase(R), 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. RESULTS: Among 418,182 ICSRs involving MS-DMTs, 1111 reported HPV-related conditions. Fingolimod showed the highest aROR of 3.50 (95% CIs = 2.95-4.16), followed by ocrelizumab (2.48 (1.83-3.31)) and natalizumab (1.63 (1.34-1.97)) compared to pegylated or non-pegylated interferon betas. DISCUSSION: 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. |
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| ジャーナル名 | Multiple sclerosis (Houndmills, Basingstoke, England) |
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| Pubmed追加日 | 2025/10/8 |
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| 投稿者 | Bordet, Constance; Maachi, Oumaima; Papeix, Anne-Caroline; Laigo, Pauline; Thomas, Laure; Grimaldi, Lamiae |
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| 組織名 | Clinical Research Unit, AP-HP Hopital Kremlin Bicetre, Paris-Saclay University,;Le Kremlin Bicetre, France.;Department of Neurology, Hospital Foundation Adolphe de Rothschild, Paris,;France.;Department of Neurology, Faculty of Medicine, Paris-Cite University, Paris,;Department of Pharmacovigilance, Assistance Publique-Hopitaux de Paris (AP-HP),;Chu Henri Mondor, Creteil, Paris, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41059543/ |
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