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

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In the Open-Label Extension Study, Patients Continuously Treated With ZEPOSIA for Up to 7 Yearsa Had an ARR of 0.0902
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
Endpoints were analyzed descriptively.
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.5,6
aAt the database lock (April 7, 2023), the mean (range) continuous ozanimod 0.92 mg oral daily dose exposure in DAYBREAK was 60.9 (0.03-81.5) months.1,2
bDAYBREAK is an OLE trial that enrolled participants from multiple randomized phase 1, 2, or 3 studies, including SUNBEAM and RADIANCE, and is presented as a final analysis with a database lock of April 7, 2023. Endpoints were analyzed descriptively.2
cStudy period includes DAYBREAK Day 1 through last treatment date or the data cutoff date of December 20, 2019.3
dAt data cutoff date of February 2, 2021.4
Post Hoc Analysis: Adjusted ARR for DMT-naive Patients7e
DMT-naïve at Baseline Graphic DMT-naïve at Baseline Graphic

In SUNBEAM and RADIANCE, prior treatment status (treatment naïve vs previously treated) was pre-specified, but not powered to detect a difference in the treatment effect in these subgroups. In DAYBREAK, endpoints were analyzed descriptively.

eThis analysis includes DMT-naïve patients who received oral daily dose of ozanimod 0.92 mg in SUNBEAM (≥12 months) and RADIANCE (24 months). Phase 3 trial completers were eligible for enrollment in the OLE trial (DAYBREAK-NCT02576717) of ozanimod (April 7, 2023 database lock) 0.92 mg oral daily dose.1,2,7
Analyses were based on the negative binomial regression model with parent treatment group, adjusted for region (Eastern Europe vs rest of world), age at parent baseline, and the parent baseline number of gadolinium-enhancing lesions. The natural log transformation of time on treatment is used as an offset term to adjust for patients having different exposure times.7
DMT-experienced patients who received ozanimod 0.92 mg oral daily dose (n=207) had ARR of 0.194 at the completion of the pivotal trials and ARR of 0.114 at the database lock of April 7, 2023 in DAYBREAK.1,2,7
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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 12.5,6

In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.5,6
9 of 10 Patients Showed No 3-Month CDP in SUNBEAM and
RADIANCE, and Rate of CDP Measured Up to 7 Years1,2
Graphic depicting the 3-month disability progression rate in patients
Graphic depicting the 3-month disability progression rate in patients
fCDP 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.1
gThis post hoc analysis includes patients who received ozanimod 0.92 mg oral daily dose in SUNBEAM (≥12 months) and RADIANCE (24 months). Phase 3 trial completers were eligible for enrollment in OLE DAYBREAK. The database lock for the OLE was April 7, 2023.1,2
CDP=confirmed disability progression; EDSS=Expanded Disability Status Score; NS=nonsignificant.
Compelling Efficacy
in Brain Volume Loss Data
in Pivotal Trials5,6
Compelling Efficacy in Brain Volume Loss Data in Pivotal Trials Compelling Efficacy in Brain Volume Loss Data in Pivotal Trials
Cognitive Processing Speed Data From a Post Hoc Analysis of SUNBEAM and DAYBREAK8
Cognitive Processing Speed Data From a Post Hoc Analysis of SUNBEAM and DAYBREAK8
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 Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year
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).5,9
SDMT is a tool that measures cognitive processing speed.5
hThe database lock for this analysis was April 7, 2023.2
MSFC=Multiple Sclerosis Functional Composite.
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