The impact of sex/gender on epidemiology, access to health facilities and treatment approach in people with multiple sclerosis. Results from the Italian Multiple Sclerosis and Related Disorders Register
SYNOPSIS AND RESULTS
Both sex and gender have been found to play important roles in various diseases and are crucial social determinant of health. The presence of female/male inequalities can limit access to healthcare, ultimately jeopardizing health and well-being. To improve the effectiveness of health systems, it is essential to pay closer attention to the actual disparities in health risks, health status, and access to services between men and women. Sex is a major risk factor in multiple sclerosis (MS), with women being three times more likely to be affected than men. Sex differences have also been observed in terms of disease severity, progression, and clinical course. Various studies have examined the effects of sex and gender differences on the effectiveness of treatments, but the findings are sometimes inconclusive. Overall, understanding the role of sex in MS is important for improving disease management and developing tailored treatment approaches. While many studies focused on sex differences, it is important to consider gender-related variables as well, as women and men may experience living and coping with MS differently. Although there is growing literature on sex and gender differences in MS, it often lacks clarity, contains contradictions, and is based on outdated or small case series. The aim of the present project is to provide a descriptive overview of female/male differences in MS in a large cohort of patients from Italy. This includes examining the female-to-male ratio trend, the age at onset, at diagnosis and at the first Disease Modifying Therapy (DMT) prescription trends, other sociodemographic and clinical variables, as well as access to treatments over time and across different geographic areas (referral center and residence area). Other outcomes of the present study are to evaluate female-to-male differences in subgroups from the overall cohort that could give some insights on specific and unexplored field to be further investigated (e.g., pregnancies, cognitive domain). We will investigate the trend over time of female-to-male ratio (defined as both incident and prevalent female-to-male) from 2000 to 2024, overall in Italy and according to Italian Regions and/or macro-areas, i.e., North-West, North-East, Center, South, and Islands. For all Regions and macro-areas, we will compute percent changes over 2024 versus 2014 and 2004. Moreover, we will fit the Joinpoint regression models, to identify significant changes in the linear slope of the female-to-male proportions over the whole period. For each trend segment identified by the model, we will estimate the annual percent change and, for the whole period, the average annual percent change. DMTs will be classified on the basis of their way of administration (oral, infusive, injectable), their mechanism of action, and the year of their launch on the market in Italy. Baseline characteristics of the patients will be presented using appropriate summary statistics. The times elapsed between onset, diagnosis, first access to an MS center, and first DMT, will be calculated and then will be analyzed separately for males and females. The differences in mean or median will be analyzed with parametric or nonparametric tests, depending on the distribution. Furthermore, the study will investigate whether there are female/male differences in disease progression by analyzing the Expanded Disability Status Scale (EDSS) scores and annualized relapse rates over time.
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
The impact of sex/gender on epidemiology, access to health facilities and treatment approach in people with multiple sclerosis. Results from the Italian Multiple Sclerosis and Related Disorders Register
Both sex and gender have been found to play important roles in various diseases and are crucial social determinant of health. The presence of female/male inequalities can limit access to healthcare, ultimately jeopardizing health and well-being. To improve the effectiveness of health systems, it is essential to pay closer attention to the actual disparities in health risks, health status, and access to services between men and women.
Sex is a major risk factor in multiple sclerosis (MS), with women being three times more likely to be affected than men. Sex differences have also been observed in terms of disease severity, progression, and clinical course. Various studies have examined the effects of sex and gender differences on the effectiveness of treatments, but the findings are sometimes inconclusive. Overall, understanding the role of sex in MS is important for improving disease management and developing tailored treatment approaches. While many studies focused on sex differences, it is important to consider gender-related variables as well, as women and men may experience living and coping with MS differently. Although there is growing literature on sex and gender differences in MS, it often lacks clarity, contains contradictions, and is based on outdated or small case series.
The aim of the present project is to provide a descriptive overview of female/male differences in MS in a large cohort of patients from Italy. This includes examining the female-to-male ratio trend, the age at onset, at diagnosis and at the first Disease Modifying Therapy (DMT) prescription trends, other sociodemographic and clinical variables, as well as access to treatments over time and across different geographic areas (referral center and residence area). Other outcomes of the present study are to evaluate female-to-male differences in subgroups from the overall cohort that could give some insights on specific and unexplored field to be further investigated (e.g., pregnancies, cognitive domain).
We will investigate the trend over time of female-to-male ratio (defined as both incident and prevalent female-to-male) from 2000 to 2024, overall in Italy and according to Italian Regions and/or macro-areas, i.e., North-West, North-East, Center, South, and Islands. For all Regions and macro-areas, we will compute percent changes over 2024 versus 2014 and 2004. Moreover, we will fit the Joinpoint regression models, to identify significant changes in the linear slope of the female-to-male proportions over the whole period. For each trend segment identified by the model, we will estimate the annual percent change and, for the whole period, the average annual percent change. DMTs will be classified on the basis of their way of administration (oral, infusive, injectable), their mechanism of action, and the year of their launch on the market in Italy.
Baseline characteristics of the patients will be presented using appropriate summary statistics. The times elapsed between onset, diagnosis, first access to an MS center, and first DMT, will be calculated and then will be analyzed separately for males and females. The differences in mean or median will be analyzed with parametric or nonparametric tests, depending on the distribution. Furthermore, the study will investigate whether there are female/male differences in disease progression by analyzing the Expanded Disability Status Scale (EDSS) scores and annualized relapse rates over time.
---
---
---