EXPAND INCLUDED A BROAD RANGE OF PATIENTS WITH MODERATE-TO-ADVANCED DISABILITY1,2
EXPAND INCLUDED A BROAD RANGE OF PATIENTS WITH MODERATE-TO-ADVANCED DISABILITY1,2
MAYZENT® was evaluated in EXPAND—the largest Phase III study of SPMS patients to date (N=1651)2,3
TRIAL DESIGN1,2


*Median drug exposure of 18 months.
BASELINE PATIENT CHARACTERISTICS FOR PATIENTS ON MAYZENT2
HOW TO ASSESS EDSS SCORESA range of end points was examined in the EXPAND trial1,2,4-6
Primary
end point
-
Time to 3-month CDP
Key
secondary
end points
-
Time to 3-month confirmed deterioration by ≥20% from baseline on the T25-FW test
-
Change from baseline in T2 lesion volume
Select
additional
secondary
end points
-
ARR
-
Time to 6-month CDP
-
Number of new or enlarging T2 lesions
-
Number of T1 GdE lesions
-
Brain volume loss
Select
exploratory
end points
-
Symbol Digit Modalities Test score
-
Brief Visuospatial Memory Test Revised score
-
Paced Auditory Serial Addition Test score
Post-hoc
analyses
-
Time to 3-month CDP in the active subgroup
-
Progression to wheelchair use
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ARR=annualized relapse rate; CDP=confirmed disability progression; DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; GdE=gadolinium-enhancing; MRI=magnetic resonance imaging; MS=multiple sclerosis; SPMS=secondary progressive MS; T25-FW=timed 25-foot walk.
†In EXPAND, a prespecified hierarchical analysis consisted of the primary end point and the 2 key secondary end points. The T25-FW test key end point was not significant; therefore, the T2 lesion volume key secondary end point was considered nominal. The remaining end points were not corrected for multiple comparisons.1,2
References: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2019. 2. 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. 3. New Novartis analyses at AAN show siponimod�s efficacy on disability and cognition in secondary progressive MS patients. Novartis Pharmaceuticals Corporation website. https://www.novartis.com/news/media-releases/new-novartis-analyses-aan-show-siponimods-efficacy-disability-and-cognition-secondary-progressive-ms-patients. Published April 20, 2018. Accessed March 3, 2020. 4. Data on file. Impact of Siponimod on Cognition in Patients With Secondary Progressive Multiple Sclerosis: Results From Phase 3 EXPAND Study. Novartis Pharmaceuticals Corp; 2017. 5. Data on file. Data Analysis Report Time to Wheelchair. Novartis Pharmaceuticals Corp; September 2019. 6. Data on file. Efficacy of Siponimod in Secondary Progressive Multiple Sclerosis Patients With Active Disease: The EXPAND Study Subgroup Analysis. Novartis Pharmaceuticals Corp; September 2019.