MODERATE
Research type
Research Study
Full title
Multiple sclerosis outcome determination evaluating real differences after time.
IRAS ID
195025
Contact name
Paul Gallagher
Contact email
Sponsor organisation
R&I, NHS Greater Glasgow and Clyde, Glasgow
Duration of Study in the UK
0 years, 10 months, 29 days
Research summary
Summary of Research
Disease-modifying treatments (DMTs) target the damage to the nervous system which causes the symptoms of Multiple Sclerosis (MS). Since their introduction in the 1990s, there has been controversy regarding their effectiveness in preventing long-term disability caused by MS. The clinical trials in which they are tested last only a few years, despite the condition being life-long, meaning their longer term effectiveness is uncertain. For practical and ethical reasons, a clinical trial comparing treatments over the lifetime of a large group of patients is not feasible, meaning data from routine clinical practice are the best source of information to provide evidence regarding their long-term effects.The uncertainty of the benefits of DMTs, along with their potential risks and costs, leads some MS specialists to use them only in more severely affected patients. Conversely, other MS specialists actively offer these medications early in the disease course.
Our study aims to compare patients with Multiple Sclerosis (MS) who were treated early in their disease and were switched to more effective treatments quickly, if initial treatments failed, versus those who were not treated at all or in whom treatment was delayed. We want to establish which of these strategies is the most beneficial for people with MS.
We aim to identify patients who had different treatments despite similar disease severity. We will invite these patients for clinical examination and a brain scan, and ask them to complete questionnaires in order to assess the severity of their condition and whether there is a difference between those who started treatment early and those who did not.
Funding for this study is being sought from the pharmaceutical industry but all results will be analysed and reported independently by the research team.
Summary of Results
Of 298 pwRRMS diagnosed in 2010-11, 141 had sufficient data for inclusion and 81 agreed to participate, with 16 pairs (N = 32) matched and assessed.
Participants were well matched on baseline data. In the early treated group, median time on any DMT was 10.8 years (range 0.4-12.5) and 4 (0-11.5) for the late/never treated group: 7/16 (44%) of this group never received DMT. In the early treated group, all were initiated onto injectable 1st-line DMTs. Of those treated later (9/16), 7 participants (78%) started a 1st-line DMT. There were no serious adverse events in participants treated with a DMT.
The trend for all clinicoradiological outcomes favoured the late/never treated group but this only reached statistical significance for patient reported cognition scores [PROMIS, mean 124 (SD 28) vs 93 (SD 32), p=0.02]. There was no significant difference in relapse outcomes. Despite this, early-treated patients were significantly happier with their treatment choice (100% vs 50%, p=0.008).
Conclusion:
This study was novel in deeply phenotyping real-world pwRRMS to compare the effects of early DMTs, with over 10 years follow-up. In contrast to other studies, early DMT use was not associated with significant benefit in our cohort. This may reflect sampling, residual confounding in matching variables, DMT choice or that early treatment was not beneficial, albeit participants preferred the early treatment approach.REC name
West of Scotland REC 5
REC reference
16/WS/0017
Date of REC Opinion
23 Mar 2016
REC opinion
Further Information Favourable Opinion