
92.4% vs 92.2% for Avonex Showed No Confirmed 3-Month Disability Progression
aA 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.2,3
The Mean Number of Relapses Experienced During the 12 Months Prior to Initiating Therapy Was 1.3 for Both SUNBEAM and RADIANCE1
GdE Lesions at Baseline
The mean number of GdE lesions observed in patients at baseline for both ZEPOSIA and Avonex was 1.8 in SUNBEAM and 1.7 in RADIANCE2,3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
GdE=gadolinium enhancing.
T2 Lesions at Baseline
The mean number of T2 lesions observed in patients at baseline for both ZEPOSIA and Avonex was 54 in SUNBEAM and 48 in RADIANCE2,3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
92.4% vs 92.2% for Avonex Showed No Confirmed 3-Month Disability Progression
7.6% of patients treated with ZEPOSIA (n=67/880) experienced 3‑month CDP, as measured by EDSS, similar to Avonex (7.8%; n=69/889) (P=NS)1,3
Statistical significance was not reached for the pooled confirmed disability progression.3
aCDP 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 SUNBEAM (1 year) and RADIANCE (2 years) studies.1
CDP=confirmed disability progression; EDSS=Expanded Disability Status Scale; NS=nonsignificant.Median EDSS Score at Baseline1
SUNBEAM (1-year study) 2.5
RADIANCE (2-year study) 2.5
Endpoint was not part of the statistical analysis hierarchy.2,3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
Endpoint was not part of the statistical analysis hierarchy.2,3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
Endpoint was not part of the statistical analysis hierarchy.2,3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.2
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.3
92.4% vs 92.2% for Avonex Showed No Confirmed 3-Month Disability Progression
Patients Classified as Having No Disability Progression Did Not Show Sustained Worsening for 3 Consecutive Months1c
7.6% of patients treated with ZEPOSIA (n=67/880) experienced 3‑month CDP, as measured by EDSS, similar to Avonex (7.8%; n=69/889) (P=NS)1,3
Statistical significance was not reached for the pooled confirmed disability progression.3
aStudy designs: SUNBEAM (1 year; N=1346) and RADIANCE (2 years; N=1313) were multicenter, randomized, double-blind, double-dummy, active treatment-controlled studies of daily oral ozanimod 0.46 mg (not approved for maintenance dose) or 0.92 mg vs weekly Avonex (interferon beta-1a), 30-μg intramuscular injection. Primary endpoint: ARR was assessed for ZEPOSIA and Avonex at 1 year and 2 years. Secondary endpoints: The number of new or enlarging T2 lesions and the number of GdE lesions were assessed for ZEPOSIA and Avonex at 1 year and 2 years. In addition, confirmed disability progression was prospectively evaluated for ZEPOSIA and Avonex in a pooled analysis from the 1-year and 2-year studies. There was no significant difference in 3-month confirmed disability between ZEPOSIA and Avonex.1-3
bA 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.2,3
cCDP 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 SUNBEAM (1 year) and RADIANCE (2 years) studies.1
ARR=annualized relapse rate; CDP=confirmed disability progression; EDSS=Expanded Disability Status Scale; GdE=gadolinium enhancing; MS=multiple sclerosis; NS=nonsignificant.
References: 1. ZEPOSIA. Prescribing information. Bristol Myers Squibb; 2020. 2. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020 and Suppl 1-26. doi:10.1016/S1474-4422(19)30239-X 3. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31. doi:10.1016/S1474-4422(19)30238-8
ZEPOSIA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
Avonex® is a registered trademark of Biogen.
This information is intended for U.S. Healthcare Professionals.