The BeAMS Study. Long-term Benefits and Adverse Effects of Beta-interferon for Multiple Sclerosis: UK Risk Sharing Scheme amendment
Although disease modifying drugs (DMTs) for multiple sclerosis (MS) have been used for many years, both in British Columbia and in the UK, there is still considerable uncertainty about the longer term benefits and cost-effectiveness of treatment. The UK MS risk sharing scheme (RSS) is a 10-year follow up of a cohort of some 5,400 treatment-nave patients who were assessed as suitable for treatment under the criteria then operated by the Association of British Neurologists and began treatment soon after entry into the scheme. Disease progression for the RSS patients will be compared at 2-yearly intervals with disease progression in a natural history cohort of untreated patients, now a subset of patients in the British Columbia MS (BCMS) dataset. This work has been ongoing since 2009.
The key research question is: what are the longer-term effects of treatment with DMTs in treating patients with relapsing remitting (RR) or secondary progressive (SP) MS? Specifically, is it reasonable to extrapolate the treatment effects seen in the course of randomised controlled trials (RCTs) typically, over 2-4 years to predict treatment benefits over the typical 20-30 year course of the disease?
The null hypothesis is that the rate of disease progression for patients treated with a given DMT, relative to disease progression in untreated patients, is constant over the 10 years of follow-up in the RSS.