Incidence, Prevalence of Multiple Sclerosis in CPRD – Burden of Mortality, Infection and Cancer Among Patients With Multiple Sclerosis

Study type
Protocol
Date of Approval
Study reference ID
20_060
Lay Summary

Multiple sclerosis (MS) is the most common cause of serious neurological disability in young adults. It is estimated that more than 2.3 million people have MS worldwide. MS has a chronic course that carries a heavy family, economic and social services burden on a permanent basis.This burden has multiple factors and reflects both the impact of MS relapses on patients’ health, quality of life and productivity and the effects of various diseases associated with MS. Patients with MS also have an underlying predisposition to infections. Both systemic and central nervous system infections are major complications of MS. We wish to investigate the characteristics of patients with MS and explore the occurrence and type of infections and cancer among them compared to the general population (free of MS).
The results of our study are expected to help ascertain a better understanding MS patients profiles to improve appropriate management and treatment.

Technical Summary

Multiple Sclerosis (MS) is estimated to affect to more than 2.3 million people worldwide. The chronic course of MS is associated with a high morbidity burden, and an underlying predisposition to infections, including opportunistic infections. Both systemic and central nervous system (CNS) infections are major complications of MS.
We aim to investigate the natural history of MS in UK, describing the characteristics of these patients and explore the occurrence of infections and cancer among patients with MS compared to the general population (free of MS).
Primary Objectives: to estimate the prevalence and incidence rate of MS in the UK general population, and describe the distribution of comorbidity and co-medication in a MS population. As well as to estimate and compare the incidence of infections in MS and general population cohorts.
Secondary Objectives: to estimate and compare all-cause mortality rate and cancer and breast cancer incidence in particular in both study cohorts.
This is a population-based retrospective cohort study, using the CPRD database with available links (hospitalization, death). During the enrolment period (1/1/2000-31/12/2016), all individuals aged 2-79 years of age, registered for at least two years in CPRD database will be included. And we will ascertain the two study cohorts: 1) patients with MS recorded diagnosis and 2) comparison general population cohort (free of MS), random sample frequency-matched to individuals in the MS cohort. Among both cohorts we will ascertain the first occurrence of infection, cancer and death during study follow-up.
Statistical analyses will be performed using STATA, estimating rates of MS and outcomes, detailed descriptive analyses of demographic, co-medications and comorbidities variables. Survival analysis and multivariate Cox hazards model to estimate the adjusted hazard ratios of mortality/outcome in both cohorts. Separate nested case-control analyses will be performed, one per study outcome if numbers permit.

Health Outcomes to be Measured

Prevalence and incidence rate of multiple sclerosis (MS) in the UK general population.
Incidence of infections in MS population and in the general population free of MS.
All-cause mortality in MS population and the general population free of MS.
All cancer and breast cancer incidence in particular, among MS population and the general population.

Collaborators

Pam Jayia - Chief Investigator - Roche
Boris Addow - Corresponding Applicant - Roche
Ana Ruigomez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Luis Alberto Garcia Rodriguez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Oscar Fernández Cantero - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )

Linkages

HES Accident and Emergency;HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Score