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ZEPOSIA Delivered Powerful Efficacy in Reducing ARR vs Avonex in Pivotal Trials1

In the ongoing open-label extension study, patients continuously treated with ZEPOSIA up to 6 yearsa had an ARR of 0.0932
Chart comparing ARR in pivotal trials and OLE between SUNBEAM and RADIANCE trials Chart comparing ARR in pivotal trials and OLE between SUNBEAM and RADIANCE trials
A relapse was defined as the occurrence of new or worsening neurological symptoms persisting for more than 24 hours attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days.3,4
*DAYBREAK is an ongoing OLE trial that enrolled participants from multiple randomized phase 1, 2, or 3 studies, including SUNBEAM and RADIANCE, and is presented as an interim analysis with a data cutoff of February 1, 2022. Endpoints were analyzed descriptively.2,5,6
aAt data cutoff (February 1, 2022), mean (range) continuous ozanimod 0.92 mg exposure in DAYBREAK was 56.4 (0.03-74.7) months.2
bStudy period includes DAYBREAK Day 1 through last treatment date or the data cutoff date of December 20, 2019.5
cAt data cutoff date of February 2, 2021.6
Proven Superior vs Avonex in Reducing Lesions Across All Secondary Measures of MRI Activity1
Chart comparing reduction of GdE lesions and new/enlarging T2 lesions between SUNBEAM and RADIANCE trials Chart comparing reduction of GdE lesions and new/enlarging T2 lesions between SUNBEAM and RADIANCE trials
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.3,4
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3,4
9 of 10 Patients Showed No Confirmed 3-Month
Disability Progression1
Secondary endpoint, confirmed disability progression at 2 years Secondary endpoint, confirmed disability progression at 2 years

92.4%

vs 92.2% For Avonex Showed No Confirmed
3-Month Disability Progression

POOLED ANALYSIS

92.4% vs 92.2%

For Avonex Showed No Confirmed
3-Month Disability Progression

Graphic depicting the 3-month disability progression rate in patients
Statistical significance was not reached for the pooled CDP.
7.6% of patients treated with ZEPOSIA (n=67/880) experienced 3-month confirmed disability progression (CDP), as measured by EDSS, similar to Avonex (7.8%; n=69/889) (P=NS)1,4
CDP was defined as at least a 1-point increase from baseline EDSS confirmed after 3 months and after 6 months. CDP was prospectively evaluated in a pooled analysis from the SUNBEAM and RADIANCE studies.
EDSS=Expanded Disability Status Score; NS=nonsignificant.
Compelling Efficacy
in Brain Volume Loss Data
in Pivotal Trials3,4
Compelling Efficacy in Brain Volume Loss Data in Pivotal Trials Compelling Efficacy in Brain Volume Loss Data in Pivotal Trials
Post Hoc Analysis: Cognitive Processing Speed Data From SUNBEAM and DAYBREAK7
Post Hoc Analysis: Cognitive Processing Speed Data From SUNBEAM and DAYBREAK7
Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year
ZEPOSIA: n=397 at Month 12 for SDMT;
Avonex: n=395 at Month 12 for SDMT
Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year
ZEPOSIA: n=323 at Month 60 for SDMT

Endpoint was not part of the statistical analysis hierarchy and was analyzed descriptively.3,5
The MSFC was a secondary endpoint made up of 3 components: 9-hole peg test (arm/hand function), timed 25-foot walk (ambulation), and SDMT (cognitive function).3,8
SDMT is a tool that measures cognitive processing speed.3
aThe data cutoff for this interim analysis was February 1, 2022.7
MSFC=Multiple Sclerosis Functional Composite.
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