Cardiac safety of ozanimod in ulcerative colitis and relapsing multiple sclerosis

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Created On: 22/03/2022

A study investigated long-term cardiac safety after continuous ozanimod therapy from the phase 3 ulcerative colitis True North trial and multiple sclerosis RADIANCE and SUNBEAM clinical trials.

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Key take away

Ozanimod use seems to have a long-term cardiac safety profile in people with ulcerative colitis and relapsing multiple sclerosis.

Background

A study investigated long-term cardiac safety after continuous ozanimod therapy from the phase 3 ulcerative colitis True North trial and multiple sclerosis RADIANCE and SUNBEAM clinical trials.

Method

The study included 0.92 mg ozanimod–treated patients from True North and pooled 12 months SUNBEAM/24 months RADIANCE trials. In True North, patients in Cohort 1 were given double-blind ozanimod or placebo and patients in Cohort 2 were given open-label ozanimod in the induction period. In the maintenance period, patients with clinical response to ozanimod at ten weeks were re-randomized to double-blind ozanimod or placebo groups.

In True North, monitoring of electrocardiograms (ECGs) was done at screening, day 1, week-10, and week-52. At every visit, monitoring of heart rate was done. In the multiple sclerosis trials, monitoring of ECGs was done at screening, baseline, day 15, and end of treatment. Monitoring of heart rate was done similarly at the starting, then every three months until end of therapy. Reporting of cardiac-linked treatment-emergent adverse events (TEAEs) was done.

Result

In the ulcerative colitis trial, continuous ozanimod therapy was not linked with any substantial alterations in ECG or heart rate. There was a low occurrence of cardiac-linked TEAEs with ozanimod during induction in Cohorts 1 and 2. In maintenance, cardiac-associated TEAEs were noted in 1.3% (3/230) of people in the continuous ozanimod group. The occurrence was numerically greater in ozanimod people with (3.5% [2/57]) vs without (0.6% [1/173]) prior history of cardiovascular disease.

The cardiac-linked serious AEs were not common (pericarditis, angina pectoris, coronary artery stenosis in one patient each). In the pooled multiple sclerosis trials, no profound heart rate or ECG alterations were linked with chronic therapy up to 24 months. The occurrence of cardiac-linked TEAEs was low with ozanimod; incidence was comparable in people with (3.5% [6/171]) vs without (3.4% [24/711]) previous history of cardiovascular disorder. Notably, 2/882 people reported cardiac-linked serious AEs causing hospital admission with ozanimod in the multiple sclerosis studies.

Conclusion

The Sphingosine-1-phosphate receptor modulator ozanimod exhibited a manageable long-term cardiac safety with a reduced occurrence of bradycardia and illustrated few severe long-term cardiac safety findings in the phase III ulcerative colitis and multiple sclerosis clinical trials.