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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; nearly 10 yearsc
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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 oral daily dose 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 upper abdominal pain, 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: Incidence of Adverse Reactions" table in the Safety section, for definitions of these terms.
cFrom 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 once daily oral ZEPOSIA 0.92 mg in the parent trials and DAYBREAK was 70.4 months.1,4
dStudy 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 orally once daily (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 once daily oral 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 (February 1, 2022), the overall incidence of TEAEs for ZEPOSIA in the DAYBREAK OLE trial was 88.2%. The most common TEAEs with an incidence of at least 5% in patients treated with ZEPOSIA, sorted by decreasing incidence, were as follows: nasopharyngitis, 20.6%; headache, 16.9%; upper respiratory tract infection, 11.9%; lymphopenia, 10.5%; ALC decreased, 9.2%; back pain, 9.1%; hypertension, 8.7%; gamma-glutamyl transferase increased, 7.3%; arthralgia, 6.3%; respiratory tract infection, 6.3%; urinary tract infection, 6.3%; bronchitis, 6.2%; viral respiratory tract infection, 5.5%; and depression-related TEAEs, 5.5%. The rate of TEAEs leading to permanent treatment discontinuation was 3.6%. Severe TEAEs: The rate of severe TEAEs was 8.9%. Serious TEAEs: The rate of serious TEAEs was 14.1%.4
ARR=annualized relapse rate; GdE=gadolinium enhancing; RMS=relapsing forms of multiple sclerosis; SDMT=Symbol Digit Modalities Test.
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