For your patients with RMS1


Powerful efficacy in reducing ARR,
GdE lesions,
and new/enlarging T2
lesions vs Avonex®1a
Data on brain volume and
cognitive processing
in secondary, exploratory
and post hoc analysis2,3
Safety comparable to Avonex in
overall incidence
of adverse
and generally similar
safety in
the ongoing long-term
extension study; up to 9 years*
*From the first patient randomized (October 18, 2012) through the DAYBREAK data cutoff (February 1, 2022), the maximum continuous exposure was 110.8 months. The mean exposure to ZEPOSIA 0.92 mg in the parent trials and DAYBREAK was 70.4 months.4
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. 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. Serious 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 the full Prescribing Information for additional SUNBEAM and RADIANCE data. See the IN PIVOTAL TRIALS table inside for definitions of these terms.
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. These data are presented as an interim analysis with a data cutoff of February 1, 2022. Patients evaluated in this analysis included those receiving the FDA-approved maintenance dose of ZEPOSIA 0.92 mg (n=881) who completed the randomized phase 1 to 3 trials (the “continuous” arm), and those who received ZEPOSIA 0.46 mg (n=877) or Avonex 30 μg (n=736) during phase 1 to 3 trials before receiving ZEPOSIA 0.92 mg at DAYBREAK baseline. The primary objective was to evaluate the long-term safety of ZEPOSIA. Secondary efficacy outcomes included ARR, new/enlarging T2 lesions, and GdE lesions. Endpoints were analyzed descriptively.1,4,5
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.
Get your patients
started on ZEPOSIA
Enroll your patients in ZEPOSIA 360 Support
and help them get started on treatment.
BMS eSign
Did your patient forget to sign the ZEPOSIA Start Form? Send them a link to the form below to sign electronically.
Explore the efficacy data
ARR reductions noted in the pivotal trials, as well as secondary endpoints, exploratory endpoints, and post hoc analyses of data.
Review the safety profile
Adverse events, discontinuation rates and rates of serious infections, as well as data from the long-term extension study.
ZEPOSIA 360 Support
ZEPOSIA 360 Support™ Starter Kit Image
Free ZEPOSIA Starter Kit
for Eligible Patientse
ZEPOSIA 360 Support™ Access Support Image
Assistance with
Benefits Investigation,
Prior Authorization
and Appeals.
ZEPOSIA 360 Pre-Initiation Support Image
Assistance with baseline
eZEPOSIA Free Trial Offer: Patient must have a valid prescription for ZEPOSIA for an FDA-approved indication. Patient must be new to therapy and have not previously received a sample or filled a prescription for ZEPOSIA. Patient is responsible for applicable taxes, if any. This offer is limited to one use per patient per lifetime and is nontransferable. Cannot be combined with any other rebate/coupon, free trial, or similar offer. No substitutions permitted. Patients, pharmacists, and prescribers cannot seek reimbursement for the ZEPOSIA Free Trial from health insurance or any third party, including state or federally funded programs. Patients may not count the ZEPOSIA Free Trial as an expense incurred for purposes of determining out-of-pocket costs for any plan, including Medicare Part D true out-of-pocket costs (TrOOP). Offer is not conditioned on any past, present, or future purchase, including refills. Only valid in the United States and US Territories. Void where prohibited by law or restricted. The program is not insurance. Bristol Myers Squibb reserves the right to rescind, revoke, or amend this offer at any time without notice.

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