Multiple sclerosis (MS) is the most common disabling neurological disease among young adults in Europe and North America, and is associated with high costs, both financial and social. There have been important recent advances in the treatment of MS, but we do not yet know whether these treatments will decrease the number of health problems that occur in people with MS. We propose a study to follow patients diagnosed with MS in 2001 or after and to compare the illnesses they are diagnosed with (such as cancer or heart disease), and the medications they use, to people of similar age and sex but who do not have MS. These data will be important to inform and understand the type of health problems that people with MS have and the types of treatment that they receive from doctors.
Using data from the CPRD we will identify patients who were first diagnosed with MS during the years 2001 through 2016 and who have at least 1 year of data in their record before the first MS diagnosis. We will send GP questionnaires for a sample of the MS patients to confirm the diagnosis and obtain information on MS treatments that are not captured in the CPRD Gold, such as infusions. We will match up to 10 patients without MS to each MS patient on age, sex general practice, year of registration in the CPRD, and calendar time. We will describe basic characteristics of the MS and non-MS cohorts in each database at baseline and estimate the risk (cumulative hazard function) of each study outcome at various times of follow-up in both cohorts using the Kaplan Meier method. Each patient in the MS and non-MS cohorts will be followed forward in time and using Byar’s method we will estimate cumulative incidence rates at the end of follow-up of each of the study outcomes, with 95% confidence intervals, stratified by age, sex and year of MS diagnosis.
For MS and non-MS patients who were free of the comorbidities and medications described below, at cohort entry, we will follow them forward from the cohort entry data to identify newly diagnosed outcomes and medications (cardiovascular diseases, cancers, respiratory diseases, psychiatric diseases such as depression, infections, and other autoimmune diseases. For medications, we will identify MS treatments as well as treatments for cardiovascular disease and the other comorbidities).
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Anders Lindholm - Collaborator - Celgene Ltd
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Guido Falcone - Collaborator - Yale University
John Freeman - Collaborator - Celgene Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Sally Lee - Collaborator - Celgene Ltd
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data