New MS drug could slow down 'Secondary Progressive' stage of disease

For the first time, a new drug has been shown to slow the progression of disability in Secondary Progressive Multiple Sclerosis (SPMS), a severe form of the condition, which gets steadily worse over time.

Up until now, there has never been a treatment that can help stem the progression of SPMS.

MS is a disease that affects the central nervous system. It involves the nerves losing their protective coating of myelin and is a life-long condition that progresses over time and features a range of potential symptoms depending on the area of the central nervous system affected. Problems that can occur include, balance, fatigue, stiffness, spasms, and memory problems.

The results of the double-blind phase three trial, published in medical journal, The Lancet, are from research into the effect of a trial drug called siponimod.

The research, funded by Novartis Pharma, indicates that the drug may directly prevent degeneration of nerve fibres by suppressing autoimmune attack and promoting recoating of damaged nerves in the central nervous system. It was noted in the report that these improvements are still relatively small.

“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,” says lead author, professor Ludwig Kappos, at the University of Basel, Switzerland.

The professor continued: “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.”

Most cases of MS present as what is often referred to as relapsing-remitting MS (RRMS). According to the MS Trust, RRMS is a pattern of symptoms which alternates between having relapses and being in remission. More than half of patients with RRMS later develop Secondary Progressive MS (SPMS) within 15-20 years. The MS Society describes the SPMS stage as when disability gets steadily worse.

For the siponimod trial, 1,645 patients were randomly assigned to treatment with either siponimod or a placebo to see if the drug could potentially stem the progression of SPMS. 1327 people completed the study.

Patients in the study had had MS for about 17 years and experienced SPMS for 4 years. More than half of the group trialled needed walking assistance.

For every patient receiving a placebo, two received siponimod. The trial involved patients aged 18-60 who had moderate or advanced disability from 292 centres in 31 countries. The patients were either given 2mg of siponimod once a day (1099 patients), or a placebo (546 patients) for up to three years or until their disability had progressed after six months.

Results showed that 26 per cent saw their disability worsen after three months taking siponimod compared with 32 per cent taking a dummy drug.

This new research arrives in the same week as impressive results for a therapy for relapsing remitting MS that involves cancer drugs and a stem cell transplant.

Not everyone in the scientific community is convinced that the trial results are conclusive. In an accompanied quote from the report, Dr Luanne Metz, from the University of Calgary, Canada, expressed caution: She said: “Although siponimod seems to reduce the time to confirmed disability in SPMS, the treatment effect was small.

“In our opinion, the reduction in the proportion of participants reaching the primary endpoint of only 6 per cent and the absence of a significant difference for the key secondary clinical outcome are disappointing results and do not suggest that siponimod is an effective treatment for SPMS.”

The doctor went on to say that, in her opinion, confirmation of the drug’s effectiveness for treating SPMS would require a second trial.