Introduction

Siponimod (trade name: Mayzent) has been approved in Germany since January 2020 for the treatment of active secondary progressive multiple sclerosis in adults.

Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system in which the body’s immune system damages nerve pathways in the brain and the spinal cord. This can cause abnormal sensations, tiredness, arm and leg pain, partial paralysis, dizziness and trembling.

MS can take on various forms:

  • Primary progressive MS (PPMS): In this rare type of MS, the symptoms constantly get worse, usually without any distinguishable episodes. The symptoms don't get better again in this form.
  • Relapsing-remitting MS (RRMS): This type often comes in episodes, with symptom-free intervals between acute phases. Remitting means that after an episode, the symptoms will go away completely or at least get better. If many attacks occur within a short time, it is referred to as highly active relapsing-remitting MS. Relapsing MS can progress into a phase where symptoms gradually get worse independently of the attacks, but don't get better again. That is referred to as secondary progressive MS (SPMS).

Siponimod can slow down damage to the nerve cells by influencing the immune system.

Application

Siponimod is available in the form of film-coated tablets, in two doses: 0.25 mg and 2 mg. The daily dose is gradually increased from 0.25 mg to 2 mg. Siponimod is taken once daily.

Other treatments

Various medications are available for people with SPMS, including interferon beta and ocrelizumab. Best supportive care (BSC) is also an option. This should be tailored to the patient's individual needs, with the aim of relieving symptoms and improving quality of life.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of siponimod compared to the standard treatments for active SPMS.

The manufacturer only provided one study for this purpose, involving people who didn't have any episodes. The data of about 200 people in the study could be used in the analysis. Two thirds of the participants were given siponimod, and one third received a placebo (fake treatment). All of the patients also had best supportive care.

This is what was found:

What are the advantages and disadvantages of siponimod?

The study showed neither advantages nor disadvantages for siponimod compared to the placebo.

No difference

There was no difference between the treatment with siponimod and the treatment with the placebo in terms of the following aspects:

  • Life expectancy
  • Progression of disability
  • Severity of disability
  • Vision
  • Ability to walk
  • Physical and psychological limitations caused by the disease

What remains unanswered?

The manufacturer didn't provide any suitable data regarding the effect of the treatments on concentration and memory, fatigue or health-related quality of life. There also wasn't enough suitable data to assess the side effects or how the patients rated their own overall health.

Episodes of MS were less common when patients took siponimod than when they took the placebo. But because about 3 out of 4 participants were also given a treatment to modify the course of the disease before the study began, it's not clear whether the episodes that were observed during the study were episodes that had been successfully suppressed by the previous treatment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of siponimod (Mayzent).