The progression of disability in secondary progressive multiple sclerosis can be slowed down with a new drug, researchers report today.
Siponimod was tested in a double-blind, randomised, phase 3 trial and was found to be a promising therapy, having consistently reduced disability progression.
The Lancet reports on a Swiss-based trial involving 1645 patients aged 18-60 – all of whom had moderate or advanced disability – from 292 centres in 31 countries.
Out of the total cohort, 1099 participants were given 2mg of siponimod once a day, while 546 received a placebo, for up to three years or until their disability had progressed after six months. 1327 people completed the study.
At the start of the trial, on average, patients had had MS for 17 years, and had had secondary progressive MS for four years, plus 55% needed walking assistance. All had their disability levels assessed every three months, as well as MRI scans at the start of the trial, and after 12, 24 and 36 months.
The research team found that the risk of a patient’s disability worsening was 21% lower for people who took siponimod, compared to people given placebo, with 26% of people given the drug seeing their level of disability increase after three months, compared with 32% on placebo.
They believe the drug may directly prevent degeneration of the nerve fibres, suppress the autoimmune attack causing the damage, and promote recoating of the nerves in the central nervous system.
The drug had no effect on maintaining patients’ walking speed, and an assessment of walking speed after three months showed that both groups were slower when they completed a timed walk of 25 feet. However, the authors note that most of these patients already relied on walking aids, and this might have affected the test.
Although side effects were reported, the researchers say they were similar to other drugs in the same class, which leads them to believe siponimod could be a useful treatment for secondary progressive MS.
Lead author Professor Ludwig Kappos, of the University of Basel, 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."
MS Society director of research Dr Susan Kohlhaas said: “These results bring us closer to the first ever treatment for people with secondary progressive MS – so it’s big news.
“This trial showed that siponimod had a modest but significant effect in slowing disability progression – which is incredibly encouraging.”
Kappos L, Bar-Or A, Cree BAC et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. The Lancet. 23 March 2018; doi.org/10.1016/ S0140-6736(18)30475-6
Link: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30475-6/fulltext
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