Human papillomavirus–related conditions in women with multiple sclerosis receiving disease-modifying therapies: A Pharmacovigilance disproportionality analysis from the WHO vigibase®

Abstract

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®, 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.