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Long-term safety of siponimod

Kappos L, et al. Long-term efficacy and safety of siponimod in patients with SPMS: EXPAND extension analysis up to 5 years. Oral presentation at AAN. 2020;S40.003.

  • IRs of the most common AEs reported in the core+extension period were consistent with those of the core period. The long-term safety profile of siponimod for up to 5 years remained consistent with that of the core study.
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Long-term safety of siponimod

Kappos L, et al. Longer-term safety with siponimod treatment in multiple sclerosis: Pooled** analysis of data from the BOLD and EXPAND trials and their extensions. Poster presentation at ECTRIMS. 2018;P911.

  • Treatment over 2 years with siponimod 2 mg did not reveal an increase in the incidence of AEs with time, and no new safety findings were observed in the long-term pool versus the controlled pool
  • The incidence of VZV infections was higher with siponimod 2 mg versus placebo in the controlled pool, with no further increase in the IR in the long-term pool
  • No increase in the overall IR of malignant or unspecified tumours including skin malignancies was observed in the long-term pool versus the siponimod 2 mg and placebo groups of the controlled pool
**The pooled population comprised a controlled pool (all patients who received siponimod 2.0 mg [N=1148] or placebo [N=607] during the core part of the placebo-controlled studies) and a long-term pool (all patients who received at least one dose of siponimod 2.0 or 10.0 mg in the core/extension parts [N=1737])
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AE, adverse event; IR, incidence rate computed as number of patients with an AE divided by total exposure for the AE (ie, cumulated exposure until first occurrence or until end of follow-up); VZV, varicella zoster virus
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.