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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: ZEPOSIA reduced ARR vs Avonex by 48% at 1 year (0.181 vs. 0.350, respectively) and by 38% at 2 years (0.172 vs. 0.276, respectively). Secondary endpoints: ZEPOSIA reduced the number of new or enlarging T2 lesions by 48% at 1 year and by 42% at 2 years and reduced the number of GdE lesions vs Avonex by 63% at 1 year and 53% at 2 years. 9 of 10 patients showed no confirmed 3-month disability progression. There was no significant difference in 3-month confirmed disability between ZEPOSIA and Avonex.1-3
bAdverse reactions: Overall incidence of adverse reactions for ZEPOSIA vs Avonex at 1 year was 59.8% and 75.5%, respectively, and at 2 years was 74.7% and 83.0%, respectively. Across 2 head-to-head trials, the most common adverse reactions with an incidence of at least 2% in patients treated with ZEPOSIA and at least 1% greater than Avonex, respectively, were as follows: upper respiratory infection, 26% (vs 23%); hepatic transaminase elevation, 10% (vs 5%); orthostatic hypotension, 4% (vs 3%); urinary tract infection, 4% (vs 3%); back pain, 4% (vs 3%); hypertension, 4% (vs 2%); and abdominal pain upper, 2% (vs 1%). Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control. Upper respiratory infection includes nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. Hepatic transaminase elevation includes alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminase increased. Hypertension includes hypertension, essential hypertension, and orthostatic hypertension. Severe Adverse Reactions: The rate of severe adverse reactions at 1 year for ZEPOSIA was 1.6% vs 2.2% for Avonex and the rate at 2 years for ZEPOSIA was 3.5% vs 4.3% for Avonex. Severe Adverse Reactions: The rate of serious adverse reactions at 1 year for ZEPOSIA was 2.9% vs 2.5% for Avonex and the rate at 2 years for ZEPOSIA was 6.5% vs 6.4% for Avonex.2-3 Please see below for additional SUNBEAM and RADIANCE data.
cStudy design: DAYBREAK is an ongoing open-label extension (OLE) trial that enrolled participants from multiple randomized phase 1 to 3 studies including SUNBEAM and RADIANCE. This data is presented as an interim analysis with a data cutoff of February 2, 2021. Patients evaluated in this analysis included those receiving ZEPOSIA 0.92 mg (n=881) who completed the randomized phase 1 to 3 trials. Primary objective evaluated the long term safety of ZEPOSIA. Secondary objectives included ARR, new/enlarging T2 lesions, and GdE lesions. Endpoints were analyzed descriptively.4
Treatment-emergent adverse events (TEAEs): At the data cutoff (Up to 5 years), the overall incidence of TEAEs for ZEPOSIA in the DAYBREAK OLE trial was 84.7%. The most common TEAEs with an incidence of at least 4% in patients treated with ZEPOSIA, sorted by decreasing incidence, were as follows: nasopharyngitis, 19.3%; headache, 15.6%; upper respiratory tract infection, 10.9%; ALC decreased, 8.9%; lymphopenia, 8.7%; back pain, 8.1%; GGT increased, 5.9%; bronchitis, 5.8%; urinary tract infection, 5.8%; hypertension, 5.4%; respiratory tract infection, 5.4%; viral respiratory tract infection, 5.0%; and depression-related TEAEs, 4.9%. The rate of TEAEs leading to permanent treatment discontinuation was 2.7%. Severe TEAEs: The rate of severe TEAEs was 6.0%. Serious TEAEs: The rate of serious TEAEs was 11.7%.4
RMS=relapsing forms of multiple sclerosis; ARR=annualized relapse rate; GdE=gadolinium enhancing; SDMT=Symbol Digit Modalities Test.
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In the ongoing open-label extension study, patients treated with ZEPOSIA up to 5 yearsa had an ARR of 0.0954,5
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
|Overall incidence of adverse reactions||75.5%||59.8%||83.0%||74.7%|
|Severe adverse reactions||2.2%||1.6%||4.3%||3.5%|
|Serious adverse reactions||2.5%||2.9%||6.4%||6.5%|
|Overall incidence of adverse reactions||75.5%||59.8%|
|Severe adverse reactions||2.2%||1.6%|
|Serious adverse reactions||2.5%||2.9%|
|Overall incidence of adverse reactions||83.0%||74.7%|
|Severe adverse reactions||4.3%||3.5%|
|Serious adverse reactions||6.4%||6.5%|
|SUNBEAM and RADIANCE: POOLED DATA|
|Adverse Reactions||Avonex |
|Upper respiratory infectionb||23%||26%|
|Hepatic transaminase elevationc||5%||10%|
|Urinary tract infection||3%||4%|
|Abdominal pain upper||1%||2%|
|DAYBREAK (UP TO 5 YEARSe)|
|Summary of TEAEs (DAYBREAK OLE primary endpoint)||
|TEAEs leading to permanent treatment discontinuation||2.7%|
|TEAEs With Incidence of at Least 4% in Patients Treated With ZEPOSIA|
|Upper respiratory tract infection||10.9%|
|Urinary tract infection||5.8%|
|Respiratory tract infection||5.4%|
|Viral respiratory tract infection||5.0%|
An up-titration schedule should be used to reach the maintenance dose, as a transient decrease in heart rate and AV conduction delays may occur1
Minimal Pre-Initiation Requirements
Before Initiating Treatment With ZEPOSIA...
aDiabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation.
A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA.1
AV=atrioventricular; CBC=complete blood count; ECG=electrocardiogram; VZV=varicella-zoster virus.
1. ZEPOSIA. Prescribing information. Bristol Myers Squibb; 2021.
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 et al. Poster at 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); October 13-15, 2021; The Digital Experience. P737.
5. 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.
6. Data on file. BMS-REF-OZA-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
7. Data on file. BMS-REF-OZA-0004. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
8. DeLuca J, Schippling S, Montalban X, et al. Effect of ozanimod on Symbol Digit Modalities Test performance in relapsing MS. Mult Scler Relat Disord. 2021;48:102673. doi:10.1016/j.msard.2020.102673
9. Deluca J, Cohen JA, Cree BAC, et al. Effects of ozanimod on information processing speed: findings from the phase 3 SUNBEAM and DAYBREAK extension trials. Poster presented on: American Academy of Neurology (2020) Virtual Platform. Poster 1-017.
10. Drake AS, Weinstock-Guttman B, Morrow SA, Hojnacki D, Munschauer FE, Benedict RHB. Psychometrics and normative data for the Multiple Sclerosis Functional Composite: replacing the PASAT with the Symbol Digit Modalities Test. Mult Scler. 2010;16(2):228-237. doi:10.1177/1352458509354552
11. Benedict RHB, DeLuca J, Phillips G, et al. Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis. Mult Scler. 2017;23(5):721-733. doi:10.1177/1352458517690821
12. Lymphocytopenia. National Heart, Lung, and Blood Institute (NHLBI). Accessed August 23, 2021. www.nhlbi.nih.gov/health-topics/lymphocytopenia
13. Marrie RA. Comorbidity in multiple sclerosis: implications for patient care. Nat Rev Neurol. 2017;13(6):375-382. doi:10.1038/nrneurol.2017.33
This information is intended for U.S. Healthcare Professionals.