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Ozanimod in relapsing multiple sclerosis: Pooled safety results from the clinical development program.

Krzysztof W Selmaj1, Jeffrey A Cohen2, Giancarlo Comi3

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Multiple Sclerosis and Related Disorders
|April 23, 2021
PubMed
Summary

Extended ozanimod use in relapsing multiple sclerosis (RMS) showed a safety profile consistent with phase 3 trials. This analysis of ozanimod for RMS found no new safety concerns with longer exposure.

Keywords:
Adverse eventsClinical trialsMultiple sclerosisOzanimodSafety

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Area of Science:

  • Immunology
  • Neurology
  • Pharmacology

Background:

  • Ozanimod is an oral sphingosine 1-phosphate receptor 1 and 5 modulator approved for relapsing multiple sclerosis (RMS).
  • Phase 3 trials demonstrated ozanimod's efficacy and tolerability compared to interferon beta-1a.
  • This study aimed to assess the safety of extended ozanimod exposure in RMS patients.

Purpose of the Study:

  • To evaluate the safety of extended ozanimod exposure in participants with RMS.
  • To compare the safety profile of long-term ozanimod treatment with data from phase 3 trials.

Main Methods:

  • Pooled incidence and duration-adjusted incidence rates of treatment-emergent adverse events (TEAEs) were analyzed.
  • Data were integrated from Phase 1, Phase 2 (with extension), and two Phase 3 trials, including an open-label extension (OLE).
  • Results were compared against pooled data from the Phase 3 trials.

Main Results:

  • Over 2600 RMS participants received ozanimod, with mean exposure exceeding 32 months.
  • Incidence rates of TEAEs and serious TEAEs were similar between the overall population and the Phase 3 population.
  • No serious opportunistic infections or high-grade atrioventricular blocks were observed; hepatic enzyme elevations decreased, malignancy rates remained low, and pulmonary function showed minimal changes. Macular edema occurred in seven participants with risk factors.

Conclusions:

  • Extended ozanimod exposure in a larger RMS population did not reveal new safety concerns.
  • The safety findings are consistent with previously reported Phase 3 trial results.
  • Ozanimod demonstrates a well-tolerated safety profile for long-term RMS treatment.