Safety and efficacy of siponimod for relapsing-remitting MS

Fingolimod is an oral tablet, approved by the Food and Drug Administration (FDA) in 2010 for relapsing-remitting MS.

Similar to fingolimod, siponimod works by trapping a certain type of immune cell (called a T-cell) in the body’s lymph nodes. This stops them from getting into the brain and spinal cord, where they would cause damage to the protective myelin covering around the nerves. Compared to fingolimod, siponimod performs more selectively on T-cells and therefore may have fewer side effects while maintaining similar beneficial effects.

The current study is an extension of a previously reported trial on siponimod (called the BOLD study). It further investigates whether this oral tablet is safe and effective for people with relapsing-remitting MS.

184 people with MS from 73 centres in the USA and nine centres in Europe, Canada, and Russia took part in this study. They were separated into five groups, each given different dosages of siponimod.

MS activity, as demonstrated by MRI scans, was reduced across all groups. However, there was no change in clinical disability measured using the Expanded Disability Status Scale (EDSS). There was no effect on the rate of brain shrinkage, which is higher in people with MS than healthy people. The rate of relapse remained low in all groups.

Among the groups, between 84% and 96% of people who received siponimod experienced side effects, nine people experienced serious side effects. Side effects included throat infections, headache, and a change in liver enzymes.

The authors suggest that siponimod trials should continue for the next phase of the trial (phase 3) which will involve more participants and could provide more definitive answers.

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