Studies Support Use of Oral Ozanimod to Treat Relapsing Multiple Sclerosis

Studies Support Use of Oral Ozanimod to Treat Relapsing Multiple Sclerosis

Publication date: Sep 10, 2019

Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial [published online September 3, 2019].

Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial [published online September 3, 2019].

This randomized, double-blind, double-dummy, active-controlled phase 3 trial was held at 152 academic medical centers and clinical practices in 20 countries. Patients included in the study had relapsing MS, a baseline expanded disability status scale score of 0. 0 to 5. 0, and either 1 or more relapse in the 12 months prior to screening or 1 or more relapse in the previous 24 months plus at least 1 gadolinium-enhancing lesion in the 12 months before screening. Patients were randomly assigned 1:1:1 to be treated for at least 12 months with either once-daily oral ozanimod 1. 0 mg (n = 447) or 0. 5 mg (n = 451) or weekly interferon β -1a 30 μg (n = 448).

Only 13 (2. 9%) patients taking ozanimod 1. 0 mg and 7 (1. 5%) patients taking ozanimod 0. 5 mg discontinued due to AEs compared with 16 (3. 6%) patients who received interferon β-1a. The second studywas a 24-month, multicenter, double-blind, double-dummy phase 3 trial with 1320 patients with relapsing MS at 147 medical centers and clinical practices in 21 countries.

A total of 1313 patients received a study drug, and they were randomly assigned 1:1:1 to be treated with either once-daily oral ozanimod 1. 0 mg (n = 433) or 0. 5 mg (n = 439) or weekly interferon β -1a 30 μg (n = 441).

Concepts Keywords
Disability Interferon beta-1a
Double Blind Multiple sclerosis
Gadolinium Ozanimod
Incidence Oxadiazoles
Interferon Nitriles
Interferon Beta 1a Ethanolamines
Lancet Antivirals
Lesion Chemistry
Multiple Sclerosis Immunology
Neurology Medical specialties
Relapse Cytokines
Oral therapy
Interferon 1a
Ozanimod
Interferon 1a interferon
Multiple Sclerosis
Multiple sclerosis SUNBEAM
MS

Semantics

Type Source Name
drug DRUGBANK Ozanimod
disease MESH Multiple Sclerosis
disease DOID Multiple Sclerosis
disease MESH relapse
drug DRUGBANK Interferon beta-1a
gene UNIPROT ARID1A
drug DRUGBANK Gadolinium
gene UNIPROT MAP6
gene UNIPROT TLE5

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