Clinical Study Design
Study 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
ARR=annualized relapse rate.
Baseline characteristics remained consistent across both studies.1-3
|Mean Age||Median EDSS Score||Mean Time Since Initial MS Diagnosis||Mean Number of Relapses in Previous|
|Mean GdE Lesion Count||Mean T2 Lesion Count||Mean % of Patients Previously Treated WIth DMTsc|
|SUNBEAM||35 Years||2.5||3.7 Years||1.3||1.8||54||31%|
|RADIANCE||36 Years||2.5||3.8 Years||1.3||1.7||48||29%|
bBaseline characteristics include the 0.92-mg dose of ZEPOSIA and the 30-μg dose of Avonex. The 0.46-mg dose of ZEPOSIA (not approved for maintenance dose) is not included.
cDMT includes a range of non-steroid therapies such as interferon beta-1a, pegylated interferon beta-1a, interferon beta-1b, glatiramer acetate, daclizumab, dimethyl fumarate, teriflunomide, and mitoxantrone (SUNBEAM only).
DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; GdE=gadolinium enhancing; RMS=relapsing multiple sclerosis.
bpm=beats per minute; MI=myocardial infarction; MS=multiple sclerosis; QTcF=corrected QT interval using Fridericia’s formula.
This information is intended for U.S. Healthcare Professionals.