A new drug is the first to slow the progression of disability in secondary progressive multiple sclerosis – a severe form of the disease for which there is currently no treatment to prevent progression.
The clinical trial, co-authored by researchers from Queen Mary University of London and published in The Lancet, found that progression to higher levels of disability was less common in people given the drug (called siponimod), compared to those given a placebo.
After three months, only a quarter of patients saw their disability progress on the drug, compared to a third of those given placebo. Further research into the long term use of the drug is ongoing. The authors also note that the drug had some side effects.
Multiple sclerosis (MS) is a condition that affects the central nervous system, and involves the nerves losing their protective coating of myelin. It is a life-long, progressive condition that can have a range of symptoms. These can include problems with vision, balance, fatigue, stiffness, spasms, and memory problems.
Most cases of MS present as relapsing-remitting MS, characterised by distinct attacks of symptoms which then fade away, and more than half of these patients later develop secondary progressive MS, where their disability gets steadily worse.
‘A landmark study’
Professor Gavin Giovannoni from Queen Mary’s Blizard Institute said: “This study is a landmark because it shifts the paradigm and shows that secondary progressive MS is modifiable. It gives hope to people with more advanced MS. We now have a treatment to slow down the inevitable worsening of disability that occurs in the secondary progressive MS phase of the disease.”
The trial involved 292 medical centres in 31 countries, with 1,327 people completing the study (including 903 given siponimod and 424 people given placebo). On average participants of the study took the study drug for 18 months.
At the start of the trial, on average, patients had had MS for 17 years, and had had secondary progressive MS for 4 years. More than half of the group needed walking assistance.
The risk of a patient’s disability getting worse was 21 per cent lower for people given siponimod, compared to people given placebo – around a quarter of people given the drug saw their level of disability increase after three months (26 per cent), compared with a third of people on placebo (32 per cent).
In addition, from the start of the trial to 24 months, the reduction in brain volume was less severe for people given the drug, compared to placebo. Loss of brain volume is a marker for tissue damage in MS.
However, more patients given the drug experienced adverse events, compared to those given placebo (89 per cent vs 82 per cent of patients), such as a slower heart rate, high blood pressure, reduced white blood cell count, and increased numbers of convulsions.
The authors say that this safety profile is similar to other drugs in the same class, and conclude that siponimod could be a useful treatment for secondary progressive MS.
Lead author Professor Ludwig Kappos, University of Basel, Switzerland, said: “So far, no drug has consistently reduced disability progression in people with secondary progressive multiple sclerosis. These patients often have a high level of disability, and preventing further progression is important for their quality of life.
“Although the effects of the drug on disability progression after three and six months are impressive, our study does not yet look at the long-term effects of siponimod, which we are investigating in the long-term follow-up of the study patients.”