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BOLD Extension

Effect of siponimod on dose-titration

Key Publications_Bold-03-02-v

Dose titration effectively reduced the negative chronotropic effect of siponimod observed at higher doses in the BOLD study

**Patients with washout are those with more than 7 days of study drug interruption between the date of the last intake of study drug in the BOLD study and the date of the first dose of the extension study drug, and all patients randomized to placebo in the BOLD study

BOLD Extension was a dose-blinded extension phase of the phase 2 BOLD study that lasted up to 24 months followed by an open-label siponimod that determined the safety and efficacy and assessed the mitigating effect of siponimod dose titration on heart rate changes during treatment initiation
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bpm, beats per minute; D, day; h, hour
1. Kappos L, et al. JAMA Neurol 2016;73:1089–1098.
* 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.