Project 170791

The BeAMS Study. Long-term Benefits and Adverse Effects of Beta-interferon for Multiple Sclerosis

170791

The BeAMS Study. Long-term Benefits and Adverse Effects of Beta-interferon for Multiple Sclerosis

$418,612
Project Information
Study Type: Observational Cohort_Study
Therapeutic Area: Neurology
Research Theme: Clinical
Disease Area: multiple sclerosis
Data Type: Canadian
Institution & Funding
Principal Investigator(s): Tremlett, Helen L
Co-Investigator(s): Gustafson, Paul A; Kingwell, Elaine; Petkau, Albert J; Rieckmann, Peter E; Van Der Kop, Mia L; Zhao, Yinshan
Institution: University of British Columbia
CIHR Institute: Population and Public Health
Program: Operating Grant
Peer Review Committee: Public, Community & Population Health - A
Competition Year: 2008
Term: 3 yrs 0 mth
Abstract Summary

Multiple Sclerosis (MS) is a relatively common disease of the brain and spinal cord, leading to disability, severe fatigue, and coordination problems; its cause is unknown. Canada has some of the world's highest rates; three more Canadians are diagnosed with MS everyday. There is no known cure and available drugs, such as the beta-interferons (IFNB), are only partially effective, require frequent injections and are very expensive. Most studies focus on how well these drugs work in the short-term, and only against certain facets of MS, whereas in reality, patients maybe on these drugs for many years. We do not fully know about all the possible long-term benefits and side effects associated with their use. Given the estimated 75,000 people with MS in Canada, and the increasing popularity of the MS drugs, the long-term beneficial effects of these drugs could translate into a substantial improvement in the health of people with MS. Conversely, if not effective, then many people could be unnecessarily exposed to these drugs. There have been few studies as large as ours investigating a range of possible side effects, including depression. In addition, we will examine whether the IFNBs have beneficial or even harmful effects which are more difficult to measure, but could result in overall changes to health service usage such as hospital admissions and physician visits as well as employment-related issues. This research brings together for the first time data collected for over two decades by physicians and pharmacists contributing to multiple large health databases. This important research will help develop a framework in which to evaluate the benefits and side effects of future new drugs for MS. Our study is a cost-effective way of spending research dollars, costing the equivalent of placing just six people with MS on IFNB treatment for five years. The study will benefit from its independence from the pharmaceutical industry, the manufacturers of IFNB.

Research Characteristics

This project includes the following research characteristics:

Big Data Analytics
Cost Effectiveness
Budget Impact
Health Technology Assessment
Resource Utilization
Productivity Outcomes
Policy Evaluation
Real World Evidence
Data Sharing
Comorbidity Focus
Registry Linkage
Knowledge Translation Focus
Safety Focus
Quality of Life
Composite Endpoint
Vulnerable Populations
Study Justification

"This research brings together for the first time data collected for over two decades by physicians and pharmacists contributing to multiple large health databases."

Novelty Statement

"We do not fully know about all the possible long-term benefits and side effects associated with their use."

Methodology Innovation

using large linked health databases to investigate long-term effectiveness and safety of beta-interferon for MS

Keywords
Data Linkage Drug Adverse Effects Drug Effectiveness Epidemiology Health Care Utilization Multiple Sclerosis