Summary

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• This summary is based on the review of 11 systematic review(s)/meta-analysis(es). ^[1-11]
• Relapses and Disease Progression: Siponimod did not show moderate or high certainty evidence of reducing relapses compared to placebo at 12 and 36 months, but it was effective in delaying disease progression at 24 months (high certainty). Specifically, it was statistically significantly more effective than interferon beta-1a and interferon beta-1b for the time to 6-month confirmed disability progression.
• MRI (magnetic resonance imaging) Outcomes: Siponimod may reduce the number of gadolinium-enhancing T1-weighted lesions at two years of follow-up, though this finding is based on very low-certainty evidence.
• CYP2C9 Genotype Influence: The effectiveness and safety of siponimod are influenced by the CYP2C9 genotype, necessitating genotype testing prior to treatment initiation to determine appropriate dosing and mitigate potential safety risks.
• Focus on SPMS (secondary progressive multiple sclerosis): All studies included in the analysis primarily focused on adults with secondary progressive multiple sclerosis (SPMS), indicating that the findings are specific to this population.
• Adverse Events (AEs): Siponimod may lead to an increase in general adverse events compared to placebo, with common AEs including headache, back pain, bradycardia, dizziness, fatigue, influenza, urinary tract infection, lymphopenia, nausea, and upper respiratory tract infection, although this finding is based on low-certainty evidence.
• Serious Adverse Events (SAEs): There is a potential for increased serious adverse events associated with siponimod compared to placebo, including cardiovascular issues such as bradyarrhythmia and hypertension, though this is also based on low-certainty evidence.
• Discontinuation Rates: The likelihood of treatment discontinuation due to adverse events is probably increased with siponimod, supported by moderate-certainty evidence.