Prescribing information

 

The efficacy profile of MAYZENT was characterised in the EXPAND study and exploratory post-hoc analyses.

MAYZENT demonstrated efficacy in a range of MS outcome measures1–5

Image showing the outcome measures evaluated in the EXPAND study: acute disease activity, T2 lesion load, cognitive processing speed, confirmed disability progression, and brain volume loss         

 Icon for confirmed disability progression

MAYZENT impact on disability progression outcomes

  • MAYZENT was proven to slow progression in SPMS patients with active disease.5,6*

Charts showing time to 3-month confirmed disability progression over 42 months, and time to 6-month confirmed diasbility progression in patients with active disease

The EXPAND trial was a randomised, double-blind, placebo-controlled, phase III study of 1651 patients with SPMS over 24 months, followed by an optional open-label extension.1

*In a subgroup analysis in EXPAND, SPMS with active disease was defined as patients with relapse in the 2 years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline.5
Time to 3-month CDP was defined as a ≥1-point increase from baseline in EDSS score (0.5-point increase for patients with a baseline EDSS score of ≥5.5), sustained for 3 months.1
Time to 6-month CDP was defined as a ≥1-point increase from baseline in EDSS score (0.5-point increase for patients with a baseline EDSS score of ≥5.5), sustained for 6 months.1

CDP, confirmed disability progression; CI, confidence interval; EDSS, Expanded Disability Status Scale; Gd, gadolinium; HR, hazard ratio; SPMS, secondary progressive multiple sclerosis.

 Infographic showing time to 3-month diasbiltiy progression, 6-month diasability progression and progression to wheelchair dependence in total study population.

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

*Time to 3-month CDP was defined as a ≥1-point increase from baseline in EDSS score (0.5-point increase for patients with a baseline EDSS score of ≥5.5), sustained for 3 months.1
Time to 6-month CDP was defined as a ≥1-point increase from baseline in EDSS score (0.5-point increase for patients with a baseline EDSS score of ≥5.5), sustained for 6 months.1
Under the assumption of the model (stable effect over time), patients with a baseline EDSS score of 6.5 had a 36% risk reduction of progressing to EDSS >7 (P=0.0483).

CDP, confirmed disability progression; CI, confidence interval; EDSS, Expanded Disability Status Scale; SPMS, secondary progressive multiple sclerosis.


 Icon for brain volume loss

MAYZENT reduced grey matter atrophy in the total patient population

 Infographic showing reduction in brain volume loss and reduction of cortical grey matter loss.

 


Icon for cognitive processing speed

MAYZENT impact on cognitive decline

MAYZENT reduced the risk of cognitive decline in SPMS patients with active disease*

 Infographic showing reduction in the 4-point worsening on the Symbol Digit Modalities Test in patients with active disease.

Other cognition-related exploratory analysis endpoints related to BVMT and PASAT were not statistically significant.3

Change in cognitive processing speed on SDMT score was an exploratory endpoint.

*In a subgroup analysis in EXPAND, SPMS with active disease was defined as patients with relapse in the 2 years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline.1
The image is an example that has been copyrighted by Western Psychological Services and is available for purchase online.

BVMT, Brief Visuospatial Memory Test; CI, confidence interval; HR, hazard ratio; SDMT, Symbol Digit Modalities Test; MS, multiple sclerosis; PASAT, Paced Auditory Serial Addition Test; SPMS, secondary progressive multiple sclerosis.

MAYZENT reduced the risk of cognitive decline in the total patient population

Infographic showing reduction in the 4-point worsening on the Symbol Digit Modalities Test in the total patient population.

Other cognition-related exploratory analysis endpoints related to BVMT and PASAT were not statistically significant.3

Change in cognitive processing speed on Symbol Digit Modality Test score was an exploratory endpoint.

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

BVMT, Brief Visuospatial Memory Test; PASAT, Paced Auditory Serial Addition Test; SDMT, Symbol Digit Modalities Test; SPMS, secondary progressive multiple sclerosis.


 Icon for acute disease activity

MAYZENT impact on disease activity

MAYZENT reduced disease activity in SPMS patients with active disease*

 Infographic showing reduction in annualised relapse rate and T1 gadolinium-enhancing lesions in patients with active disease.

*In a subgroup analysis in EXPAND, SPMS with active disease was defined as patients with relapse in the 2 years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline.1

ARR, annualised relapse rate; Gd+, gadolinium-enhancing; CI, confidence interval, SPMS, secondary progressive multiple sclerosis.

MAYZENT reduced disease activity in the total patient population

Infographic showing reduction in annualised relapse rate and T1 gadolinium-enhancing lesions in the total patient population.

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

Gd+, gadolinium-enhancing; SPMS, secondary progressive multiple sclerosis.


 Icon for T2 lesion load.

MAYZENT impact on T2 lesion loads

MAYZENT had a significant effect on T2 lesion loads in SPMS patients with active disease*

 Infographic showing reduction in new or enlarging T2 lesions in patients with active disease

*In a subgroup analysis in EXPAND, SPMS with active disease was defined as patients with relapse in the 2 years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline.1

CI, confidence interval; SPMS, secondary progressive multiple sclerosis.

MAYZENT had a significant effect on T2 lesion loads in the total patient population

 Infographic showing reductions T2 lesion volume, and in new or enlarging T2 lesions in the total patient population

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

Adjusted mean over months 12 and 24, with 184 mm2 for MAYZENT compared with 879 mm2 for placebo (P<0.0001).1
0.7 (mean for MAYZENT) compared with 3.6 (mean for placebo) (P<0.0001).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.6

CDP, confirmed disability progression; MS, multiple sclerosis; SPMS, secondary progressive multiple sclerosis.

References

  1. Kappos L et al. Lancet. 2018;391:1263–1273, plus supplementary appendix.
  2. Ziemssen T et al. J Neurol. 2016;263(6):1053–1065.
  3. Benedict RHB et al. Impact of siponimod on cognition in patients with secondary progressive multiple sclerosis: results from the phase 3 EXPAND study. Poster presented at: AAN Meeting; 26 April 2018; Los Angeles, CA, USA.
  4. Galboiz Y et al. Curr Opin Neurol. 2002;15(3):233–237.
  5. 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.
  6. MAYZENT (siponimod) Summary of Product Characteristics.
  7. Vermersch P et al. Siponimod delays the time to wheelchair in patients with SPMS: results from the EXPAND study. Presented at: the 35th ECTRIMS Congress; 11–13 September 2019; Stockholm, Sweden.
  8. Arnold DL, Fox R, Bar-Or A et al. Effect of siponimod on cortical grey matter and thalamic volume in patients with secondary progressive multiple sclerosis - results of the EXPAND study. Poster P382 presented at: the 35th ECTRIMS Congress and 24th Annual Conference of Rehabilitation in MS; 11–13 September 2019; Stockholm, Sweden.
  9. Benedict RH et al. Mult Scler. 2017;23(5):721–733.
  10. Strober L et al. Mult Scler. 2014;20(1):112–115.
SIP20-C001b May 2020.
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