Developing treatments and improving outcomes measurement in Multiple Sclerosis

Multiple Sclerosis (MS) affects about 100,000 people in the UK, and is the commonest cause of neuro-disability in young adults. It is most prevalent in people aged 20 to 40 years, can occur in the very young and elderly, and is three times more common in women than men. Multiple treatments exist for the inflammatory stage of relapsing-remitting MS: but none alter the course of progressive MS.

Research teams from Plymouth University Peninsula Schools of Medicine and Dentistry are in the vanguard of work in two areas: methods of measuring how people with MS feel and function (patient-reported outcome measures; PRO[M]S); and the evidence base underpinning cannabinoids as an MS treatment, and as a method to slow neurodegeneration.

The PROMS developed at Plymouth University under the leadership of Professor Jeremy Hobart has directly influenced clinical research, trials and drug licensing in MS and Alzheimer’s disease. The MS scales developed by this team are widely used by academics and commercial organisations in MS drug development and evaluation, and have resulted in new drugs being licensed. Some scales have been translated into over 60 languages. The specific measurement science methods used by this research group to construct instruments have been endorsed by the United States Food and Drug Administration, whom they have educated. 

Said Professor Hobart: “When we study new treatments for diseases we track the treatment’s effects carefully. If we track people‘s reports of how they feel and function we get a direct indicator of whether treatments are beneficial for people with the disease. PRO[M]s does this. But the measures must be good because of their critical role. Basically, they determine which new treatments doctors can prescribe, and how NHS money is spent. When poor quality measures are used the chances increase of concluding that good drugs don’t work. When that happens, people miss out on treatments that might help them. This is really important, more than people recognise. As I re-asserted in a paper in The Lancet in 2007, many measures used in clinical trials are not fit-for-purpose: the clinical trials are undermined, beneficial treatment effects will be missed. This is why we set out to develop good quality PRO measures for MS. For example, we developed a PRO measure of walking. It’s such an important daily activity for most people and in MS up to 85 per cent of people are walking disabled.”

The potential of cannabis/cannabinoids as a treatment for MS is supported anecdotally, but there has been a paucity of clinical trial evidence.

On research into the impact of medical treatment

When we study new treatments for diseases we track the treatment’s effects carefully. If we track people‘s reports of how they feel and function we get a direct indicator of whether treatments are beneficial for people with the disease.

Professor Jeremy Hobart.

Professor Jeremy Hobart

Studies led by Professor John Zajicek have addressed this evidence gap. The first study, Cannabinoids in MS (CAMS) took place over 15 weeks across 33 centres involving 667 patients. It showed evidence for symptomatic benefit of pain, spasticity and muscle spasms. CAMS also implied cannabiniods might slow down MS progression, but further study was needed. Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) randomised 493 people with progressive MS to either oral cannabis (tetrahydrocannabinol, THC) or placebo. The study showed that, while there was no overall benefit, there was a suggestion of an effect in those with a lower disability.

A further study, Multiple Sclerosis and Extract of Cannabis (MUSEC) confirmed that cannabis extract is a viable treatment option and an effective form of pain relief, for MS patients experiencing muscle problems.

Professor John Zajicek said: “To put our work into context: current treatments for MS are limited, either targeted at the immune system in the early stages of the disease or aimed at easing specific symptoms such as muscle spasms, fatigue or bladder problems.  At present there is no treatment available to slow MS when it becomes progressive.”

Welcome to the University of Plymouth’s Institute of Translational and Stratified Medicine (ITSMED).

Headquartered in the University’s prestigious new £17M Derriford Research Facility, ITSMED brings together world-class research strengths in both basic laboratory and translational clinical science, providing a strong, collaborative, interdisciplinary environment to develop high-impact, translational research of clinical relevance.

The Institute hosts two major research groups, Biomedical Research Group and Clinical Trials and Population Studies Group, with combined facilities and resources that cluster researchers with recognised expertise from across the Plymouth University Peninsula Schools of Medicine and Dentistry (PU PSMD) and beyond.

Our focus is on three core research themes: Cancer, Clinical Neuroscience and Infection, Immunity, Inflammation, facilitated by cross-cutting expertise in Diagnostics, Clinical Trials and Public Health research.

This translational research is enabled by the University of Plymouth’s UK Clinical Research Collaboration (UKCRC) registered Peninsula Clinical Trials Unit (PenCTU), Medical Statistics and Systems Biology Centre teams.

Our research strengths were confirmed by the excellent results from our submission to the Research Excellence Framework (REF) 2014 which ranked us first in the UK for quality of research outputs in clinical medicine, above medical schools at Oxford and Cambridge.