Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Up to 5 years of follow-up in the DAYBREAK open-label extension trial.
Mult Scler
; 28(12): 1944-1962, 2022 10.
Article
in English
| MEDLINE | ID: covidwho-2064612
ABSTRACT
BACKGROUND:
Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS.OBJECTIVE:
To characterize long-term safety and efficacy of ozanimod.METHODS:
Patients with relapsing MS who completed a phase 1â3 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0.92 mg/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021.RESULTS:
This analysis included 2494 participants with mean 46.8 (SD 11.9; range 0.033â62.7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85.9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11.9%) had a serious TEAE, and 75 (3.0%) discontinued treatment due to TEAEs. Serious infections (2.8%), herpes zoster infections (1.7%), confirmed macular edema cases (0.2%), and cardiac TEAEs (2.8%) were infrequent. Adjusted annualized relapse rate was 0.103 (95% confidence interval, 0.086â0.123). Over 48 months, 71% of patients remained relapse free. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups.CONCLUSIONS:
This long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Oxadiazoles
/
Multiple Sclerosis, Relapsing-Remitting
/
Indans
Type of study:
Cohort study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Mult Scler
Journal subject:
Neurology
Year:
2022
Document Type:
Article
Affiliation country:
13524585221102584
Similar
MEDLINE
...
LILACS
LIS