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Study design

EXPAND Phase 3 study design: Event-driven design allowed for adequate observation period for the assessment of efficacy and safety while reducing exposure to placebo1

EXPAND_Study Design-v
**Open-label part starts when a patient has an 'event'. ^Treatment was initiated with a 6-day titration period (0.25 mg–2 mg) with the first maintenance dose of 2 mg reached on Day 6.

The Phase 3 EXPAND study was a randomized, parallel-group, double-blind, placebo-controlled, event-driven, and exposure-driven core part (up to 3 years) followed by an open-label extension part (up to 7 years), which collected long-term data to evaluate the efficacy and safety of siponimod, for up to 10 years. Patients (aged 18–60 years) with SPMS and EDSS score of 3.0–6.5 were randomly assigned (2:1) to receive once-daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of CDP events. The primary endpoint was time to 3-month CDP. CDP was defined as a 1-point increase in EDSS if the baseline score was 3.0–5.0, or a 0.5-point increase if the baseline score was 5.5–6.5, confirmed at a scheduled visit at least 3 months later. The two key secondary endpoints were time to 3-month CDP of at least 20% from baseline in the T25FW test and change from baseline in T2 lesion volume1
  • 374 events of 3mCDP and ≥1 year of exposure for >95% randomized patients were required
  • Patients with 6mCDP had an option to switch to open-label siponimod or other DMTs while remaining in the core part of the study
  • At the EoCP, patients had the option to enter the still ongoing open-label extension part of the trial and receive siponimod for up to additional 7 years
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EXPAND population: Patient demographics and baseline disease characteristics1

Table - EXPAND population Patients-v
#Data are presented as mean±SD, unless otherwise specified
^Information on the number of relapses in the past 2 years was not available for three patients in the siponimod group and one patient in the placebo group
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 EXPAND SPMS population and Phase 3 RMS trials: Patient demographics and baseline
disease characteristics1‒7

Table - EXPAND SPMS population-latest

As there are no head-to-head trials of siponimod versus these agents, no comparisons could be made due to differences in study design

§At 2 years; §§At 96 weeks; §§§At 12 months; placebo comparator; ǁglatiramer acetate comparator; ɭIFN β-1a comparator; ¥alemtuzumab 12 mg arm only; Twice daily DMF arm only; ʆtime since diagnosis; ĬEDSS score higher than 5.0; Ɣbased on inclusion criteria; &MRI cohort; ʄInclude data of patient who received ocrelizumab or ozanimod  
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3mCDP, 3-month confirmed disability progression; 6mCDP, 6-month confirmed disability progression; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; EoCP, end of the core part; EXPAND, EXploring the efficacy and safety of siponimod in PAtients with secoNDary progressive multiple sclerosis; Gd+, gadolinium-enhancing; IFN, interferon; MRI, magnetic resonance imaging; MS, multiple sclerosis; n.r., not recorded; RMS, relapsing multiple sclerosis; SD, standard deviation; SDMT, Symbol Digit Modalities Test; SPMS, secondary progressive multiple sclerosis; T25FW, timed 25-foot walk
1.Kappos L, et al. Lancet. 2018;391:1263-1273.
2.Fox RJ, et al. N Engl J Med. 2012;367:1087-1097.
3.Coles AJ, et al. Lancet. 2012;380:1829-1839.
4.Kappos L, et al. N Engl J Med. 2010;362:387-401.
5.Hauser SL, et al. N Engl J Med. 2017;376:221-234.
6.Cohen J, et al. Lancet Neurol. 2019;18:1021-1033.
7.Comi G, et al. Lancet Neurol. 2019;18:1009-1020.
* 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.