
92.4% vs 92.2% for Avonex Showed No Confirmed 3-Month Disability Progression
ZEPOSIA n=846 |
|
Any TEAE | 80.6% |
Severe TEAEs | 4.6% |
Serious TEAEs | 9.5% |
TEAEs leading to permanent treatment discontinuation | 1.7% |
TEAEs in ≥4% of patients treated with ZEPOSIA | |
Nasopharyngitis | 17.1% |
Headache | 14.1% |
Upper respiratory tract infection | 9.5% |
Lymphopenia | 8.2% |
ALC decreased | 8.2% |
Back pain | 6.6% |
Urinary tract infection | 5.0% |
GGT increased | 4.7% |
Hypertension | 4.3% |
TEAEs are sorted by decreasing incidence in patients treated with ZEPOSIA.
GGT=gamma-glutamyl transferase; TEAE=treatment-emergent adverse event.
DAYBREAK is an ongoing OLE trial that enrolled participants from multiple randomized phase 1 to 3 studies, including SUNBEAM and RADIANCE, and is presented as an interim analysis with a data cutoff of December 20, 2019. Endpoints were analyzed descriptively.
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.3,4
bStudy period includes DAYBREAK Day 1 through last treatment date for the data-cutoff date.
Includes patients from SUNBEAM and RADIANCE clinical trials. Endpoints were analyzed descriptively.
Includes patients from SUNBEAM and RADIANCE clinical trials. Endpoints were analyzed descriptively.
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
Overall Incidence of Adverse Reactions
SUNBEAM and RADIANCE: POOLED DATA | ||
---|---|---|
Adverse Reactions | Avonex n=885 | ZEPOSIA n=822 |
Upper respiratory infectione | 23% | 26% |
Hepatic transaminase elevationf | 5% | 10% |
Orthostatic hypotension | 3% | 4% |
Urinary tract infection | 3% | 4% |
Back pain | 3% | 4% |
Hypertensiong | 2% | 4% |
Abdominal pain upper | 1% | 2% |
Adverse reactions are sorted by decreasing incidence in patients treated with ZEPOSIA.
For adverse reactions pertaining to liver function tests, increases were transient and generally resolved without discontinuation.1
Elevations of 3-fold the ULN or greater occurred in 5.5% of patients taking ZEPOSIA and in 3.1% of patients taking Avonex. The majority (79%) continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2 to 4 weeks.1
1.6%
(n=448)
vs 2.2% for
Avonex (n=445)
3.5%
(n=434)
vs 4.3% for
Avonex (n=440)
2.9%
(n=448)
vs 2.5% for
Avonex (n=445)
6.5%
(n=434)
vs 6.4% for
Avonex (n=440)
ZEPOSIA n=846 |
|
Any TEAE | 80.6% |
Severe TEAEs | 4.6% |
Serious TEAEs | 9.5% |
TEAEs leading to permanent treatment discontinuation | 1.7% |
TEAEs in ≥4% of patients treated with ZEPOSIA | |
Nasopharyngitis | 17.1% |
Headache | 14.1% |
Upper respiratory tract infection | 9.5% |
Lymphopenia | 8.2% |
ALC decreased | 8.2% |
Back pain | 6.6% |
Urinary tract infection | 5.0% |
GGT increased | 4.7% |
Hypertension | 4.3% |
TEAEs are sorted by decreasing incidence in patients treated with ZEPOSIA.
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
dData are not an adequate basis for comparison of rates between ZEPOSIA and the active control.
eIncludes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis.
fIncludes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased.
gIncludes hypertension, essential hypertension, and orthostatic hypertension.
hStudy period includes DAYBREAK Day 1 through last treatment date for the data-cutoff date.
ARR=annualized relapse rate; CDP=confirmed disability progression; EDSS=Expanded Disability Status Scale; GdE=gadolinium enhancing; GGT=gamma-glutamyl transferase; MS=multiple sclerosis; NS=nonsignificant; TEAE=treatment-emergent adverse event; ULN=upper limit of normal.
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 4. Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1-3 trials. Presented at: 8th Joint Actrims-Ectrims Meeting; September 11-13, 2020; MSVirtual2020. Presentation P0217.
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.