MORE PROGRESSED RELAPSING MS PATIENTS,
VS PLACEBO IN TIME TO 3-MONTH CONFIRMED DISABILITY PROGRESSION (P=0.013)1,10§DISCOVER PROVEN EFFICACY
RELAPSING MS PATIENTS,
MAYZENT DEMONSTRATED A
VS PLACEBO IN TIME TO 3-MONTH CONFIRMED DISABILITY PROGRESSION (P=0.013)1,10§
CDP, confirmed disability progression; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; MOA, mechanism of action; MOD, mechanism of disease; MS, multiple sclerosis; RMS, relapsing MS; S1P, sphingosine 1-phosphate; SPMS, secondary progressive MS.
*From a preplanned interim analysis of an open-label extension study.2
†Patients in EXPAND had a mean EDSS score of 5.4.10
‡Based on animal studies.8,9
§The proportion of patients with 3-month CDP for MAYZENT was 26% vs 32% for placebo. Although MAYZENT had a significant effect on CDP in patients with active SPMS (relapse in the 2 years prior to study entry), its effect in patients with nonactive SPMS was not statistically significant.1,10
References: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Data on file. Long-term Efficacy and Safety of Siponimod in Patients with SPMS: EXPAND Extension Analysis up to 5 Years. Novartis Pharmaceuticals Corp; May 2020. 3. Data on file. First and only progressing RMS treatment. Novartis Pharmaceuticals Corp; October 2021. 4. O'Sullivan C, Schubart A, Mir AK, Dev KK. The dual S1PR1/S1PR5 drug BAF312 (siponimod) attenuates demyelination in organotypic slice cultures. J Neuroinflammation. 2016;13:31. 5. Gergely P, Nuesslein-Hildesheim B, Guerini D, et al. The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate. Br J Pharmacol. 2012;167(5):1035-1037. 6. Mannioui A, Vauzanges Q, Fini JB, et al. The Xenopus tadpole: An in vivo model to screen drugs favoring remyelination. Mult Scler. 2018;24(11):1421-1432. 7. Choi JW, Chun J. Lysophospholipids and their receptors in the central nervous system. Biochim Biophys Acta. 2013;1831(1):20-32. 8. Gentile A, Musella A, Bullitta S, et al. Siponimod (BAF312) prevents synaptic neurodegeneration in experimental multiple sclerosis. J Neuroinflammation. 2016;13(1):207. 9. Bigaud M, Rudolph B, Briard E, Beerli C, Schubart A, Gardin A. Siponimod penetrates, distributes and acts on the central nervous system: translational insights. Neurology. 2020;94(suppl 15):3973. American Academy of Neurology abstract 3973. 10. Kappos L, Bar-Or A, Cree BAC, et al; for the EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263-1273.