First ever secondary progressive MS drug
23rd March 2018 - A new drug is showing promise as the first to slow disease progression in secondary progressive multiple sclerosis (SPMS).
The MS Society has called it "big news" and the findings have been published in The Lancet.
Siponimod has undergone a phase 3 trial but is not currently available to patients.
Types of MS
There are more than 100,000 people in the UK living with MS and there are 3 main types of the disease - relapsing, secondary progressive and progressive. It's a condition which affects the central nervous system and symptoms include balance, vision, and memory problems, fatigue, stiffness, and spasms.
Most cases start as relapsing MS but within 15 to 20 years more than half of those patients go on to develop secondary progressive MS.
There are a number of different disease modifying drugs (DMDs) for people with relapsing MS but, until now, there have been no treatments to stop or slow the disease advancing in patients with secondary progressive MS.
New drug - siponimod
The drug, siponimod, is taken daily as a tablet and has been developed and trialled by Novartis Pharmaceuticals.
It works by stopping certain types of immune cells from getting into the brain and spinal cord where they can cause damage to the protective coating (myelin) around the nerves.
The drug may also promote recoating of the nerves in the central nervous system.
Side effects include a slower heart rate, high blood pressure, and increased liver enzymes, and the eye condition, macular oedema.
Phase 3 trial
The drug company conducted a 3 year trial involving 1,645 patients aged 18 to 60 from 31 countries. On average, participants at the start of the trial had lived with MS for 17 years, and had secondary progressive MS for 4 years.
They were given either 2mg of siponimod once a day (1099 patients) or a placebo (dummy) tablet (546 patients).
Every 3 months their disability levels were assessed and they had MRI scans at the start of the trial and after 12, 24 and 36 months.
In all 1,327 people completed the study (903 given siponimod and 424 people given placebo). On average participants took the study drug for 18 months.
Findings – 'modest but significant'
The researchers concluded that siponimod could be a useful treatment for secondary progressive MS. They found the risk of a patient's disability getting worse was 21% lower for people given siponimod, compared to people given placebo.
Loss of brain volume is a marker for damage in MS and from the start of the trial to 24 months, the reduction in brain volume was less severe for people given the drug.
However, it had no effect on maintaining walking speed, and both the group taking the drug and the placebo group became slower after 3 months.
Further research into the long-term use of the drug is ongoing.