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Overview of the EXPAND study of MAYZENT in SPMS.

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MAYZENT was studied in EXPAND, the largest Phase III study in SPMS1

EXPAND was a randomised, double‑blind, placebo‑controlled, event and follow‑up duration driven, phase III study.1

The results were published in The Lancet in 2018.1

The core phase (randomised, double-blind and placebo-controlled) of the study was followed by an ongoing long-term open-label extension phase for up to 10 years.1

Image of the EXPAND study design. 1651 patients with secondary-progressive MS were randomised 2 to 1 to receive treatment 2 mg once daily, or placebo.

*Median drug exposure of 18 months.1

SPMS, secondary progressive multiple sclerosis.

MAYZENT was studied in a broad range of patients1

 Table showing the baseline characteristics of patients in the EXPAND study

EDSS, Expanded Disability Status Scale; MS, multiple sclerosis; SPMS, secondary progressive multiple sclerosis.

Although the EXPAND study was in a broad SPMS population, MAYZENT is indicated for treatment of adult patients with SPMS with active disease evidenced by relapse or imaging feature of inflammatory activity.1,2

Active population defined as the presence of relapses in the 2 years before screening and/or ≥1 T1 gadolinium-enhancing (Gd+) lesion at baseline.1

Indication: MAYZENT is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.2

SPMS, secondary progressive multiple sclerosis.

References

  1. Kappos L et al. Lancet. 2018;391:1263–1273, plus supplementary appendix.
  2. MAYZENT (siponimod) Summary of Product Characteristics.
  3. Gold R et al. Efficacy of siponimod in secondary progressive multiple sclerosis patients with active disease: the EXPAND study subgroup analysis. Poster P750 presented at: the 35th ECTRIMS Congress; 11–13 September 2019; Stockholm, Sweden.
SIP20-C001b May 2020.
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