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.

• Authors: Bruce Ac Cree, Krzysztof W Selmaj, Lawrence Steinman, Giancarlo Comi, Amit Bar-Or, Douglas L Arnold, Hans-Peter Hartung, Xavier Montalbán, Eva K Havrdová, James K Sheffield, Neil Minton, Chun-Yen Cheng, Diego Silva, Ludwig Kappos, Jeffrey A Cohen
• Journal: Multiple sclerosis (Houndmills, Basingstoke, England) (Mult Scler) Vol. 28 Issue 12 Pg. 1944-1962 (10 2022) ISSN: 1477-0970 [Electronic] England
• PMID: 35765217 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Indans
• Oxadiazoles
• Sphingosine-1-Phosphate Receptors
• ozanimod

Topics

• Follow-Up Studies
• Humans
• Indans (adverse effects)
• Multiple Sclerosis, Relapsing-Remitting (drug therapy)
• Oxadiazoles (adverse effects)
• Recurrence
• Sphingosine-1-Phosphate Receptors