DELIVER-MS Extension: comparing initial treatment approaches

Background

There are now over a dozen disease modifying therapies (DMTs) available for relapsing MS. DMTs are often categorised as moderate versus high efficacy, based on how effectively they prevent relapses. 

Some people choose to start with less intensive DMTs when newly diagnosed. Doctors then monitor their condition to decide if and when to step up to a high-efficacy DMT. This is called an escalation approach. But some people prefer to start with more intensive DMTs as soon as they get diagnosed. This is called an early intensive approach.

About the project

DELIVER-MS will compare both strategies and answer the important question of whether every person with MS should be recommended to take high-efficacy DMT from the outset.

The trial is following a group of around 800 people with MS for six years from starting their first DMT. The team divided the group into people who start with a milder treatment and people who start with a more intensive treatment. The participants chose their own treatment with help from their healthcare professionals, so were not assigned at random. 

The DELIVER-MS team will analyse how effective the treatments are by measuring brain shrinkage on MRI scans. This is a good indicator for long-term disability. Initially, the project was set to run for three years. Now they have funding from the National MS Society (US) to extend for a further three years.

With our additional funding, they’ll ask participants to carry out self-assessments at home, including measuring their walking speed over 25 feet and dexterity with a 9-hole peg test.  This means the team have more information about how the treatments affect disability. Importantly, they’ll also be able to determine whether using remote assessments is feasible and useful for clinical trials. 

They’ll also use our funding to analyse the routine MRI scans participants have, to continue to study brain and lesion volume changes over the 6 years.

How will it help people with MS?

The findings of this study won't just affect the people involved in DELIVER-MS. It'll also have a broader impact. It has the potential to finally demonstrate the most effective approach for initial treatment of MS. This could mean everyone with MS can have the right treatments at the right time.

We need to ensure that clinical trials are accessible to a wide range of potential participants, including those with advanced disability. If DELIVER-MS can show that remote clinical assessments are feasible and valid, more people with MS may be able to participate in other clinical trials remotely. 

The additional MRI measurements we will fund provide much more information about how the treatment might be working, helping researchers to understand MS better.