An Overview of the Efficacy and Safety of Ozanimod for the Treatment of Relapsing Multiple Sclerosis

Figures & data

Table 1 Ozanimod Main Specifics and Chemical Structure

Drug Names	Ozanimod HCL; Ozanimod Hydrochloride; RPC-1063; Zeposia
Class	Sphingosine 1-phosphate receptor modulator
Route of administration	Oral
Phase	Authorised for CIS, RRMS, and active SPMS by the FDA (March 2020) and for RRMS by the EMA (2020); phase III trials for inflammatory bowel disease
Pharmacodynamics	S1PR1 and S1PR5 agonist
Pivotal Trials	RADIANCE A, RADIANCE B, SUNBEAM
Ongoing trials	DAYBREAK, ENLIGHTEN
Pharmaceutical company	Bristol-Myers Squibb

Table 2 Comparison of Results from Pivotal Phase III Trials RADIANCE and SUNBEAM

	RADIANCE			SUNBEAM
Target	RRMS patients			RRMS patients
Mean duration of drug exposure	24 months			13.6 months
Number of participants enrolled	1320			1346
Groups of treatment	Ozanimod 0.5 mg/d, Ozanimod 1 mg/d, Interferon beta-1a			Ozanimod 0.5 mg/d, Ozanimod 1 mg/d, Interferon beta-1a
	Ozanimod 0.5 mg/d	Ozanimod 1 mg/d	Interferon-1a	Ozanimod 0.5 mg/d	Ozanimod 1 mg/d	Interferon-1a
Number of enrolled subjects for each group	443	443	434	448	451	447
Number of subjects that withdrew	65	65	45	36	26	29
ARR	0.17	0.22	0.28	0.18	0.24	0.35
Number of new or enlarging T2 lesions	1.84 at 24 months	2.09 at 24 months	3.18 at 24 months	1.47 at 12 months	2.14 at 12 months	2.84 at 12 months
Number of GdE lesions	0.18 at 24 months	0.20 at 24 months	0.37 at 24 months	0.16 at 12 months	0.29 at 12 months	0.43 at 12 months