Dataset Information

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.

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 1‒3 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 0.033‒62.7) 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, 0.086‒0.123). 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.

SUBMITTER: Cree BA

PROVIDER: S-EPMC9493410 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

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.

Cree Bruce Ac BA Selmaj Krzysztof W KW Steinman Lawrence L Comi Giancarlo G Bar-Or Amit A Arnold Douglas L DL Hartung Hans-Peter HP Montalbán Xavier X Havrdová Eva K EK Sheffield James K JK Minton Neil N Cheng Chun-Yen CY Silva Diego D Kappos Ludwig L Cohen Jeffrey A JA

Multiple sclerosis (Houndmills, Basingstoke, England) 20220628 12

<h4>Background</h4>Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS.<h4>Objective</h4>To characterize long-term safety and efficacy of ozanimod.<h4>Methods</h4>Patients with relapsing MS who completed a phase 1‒3 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.<h4>Results ...[more]

PMID: 35765217

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Dataset Information

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.

Background

Objective

Methods

Results

Conclusions

Publications

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.

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