Abstract
Objectives To evaluate the risk of cervical abnormality in women with multiple sclerosis (MS) exposed to high efficacy-disease modifying therapies (DMTs).
Methods Multi-centre retrospective cohort study in Victoria, Australia utilising data collected from 1998–2019. Data linkage matched patient data across three registries: (1) MSBase Registry (2) National HPV Vaccination Program Register (NHVPR) (3) Victorian Cervical Cytology Register (VCCR). Primary outcome was detection of any type of cytological or histological cervical abnormality classified as low-grade or worse (>/= grade 1 cervical intraepithelial neoplasia) identified on cervical screening tests. Survival methods assessed time to cervical abnormality. Crude and adjusted Cox proportional hazards were used to determine the magnitude of association of exposure to high-efficacy DMTs with cervical abnormality.
Results 248 women with MS were included in the analysis. Cervical abnormality incidence was higher for women exposed to high-efficacy DMTs (36.6/1000 patient-years (95% CI 21.7 – 51.6)) than those unexposed to high efficacy therapy (10.2/1000 patient-years (95% CI 5.5–14.9), p<0.001). High-efficacy DMT exposure was associated with a 3.79-fold increased hazard (95% CI 2.02–7.08, p<0.001) of developing a cervical abnormality. This risk persisted despite adjusting for human papillomavirus (HPV) vaccination status, smoking, hormonal contraceptive use and socioeconomic status (HR 3.78, 95% CI 1.98–7.19, p<0.001).
Conclusions A greater than 3.5-fold increased risk of cervical abnormality was detected after exposure to high-efficacy DMTs. This highlights the need for increased safety vigilance including patient-centred counselling and ensuring participation primary and secondary prevention strategies such as HPV vaccination and cervical screening programs for women with MS.
