Zeposia exhibits ‘manageable’ cardiac safety profile in UC, multiple sclerosis
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Zeposia demonstrated a low incidence of treatment-related cardiac adverse events for patients with ulcerative colitis or multiple sclerosis, according to a presenter at the Congress of the European Crohn’s and Colitis Organization.
“In both clinical trials of UC and multiple sclerosis with ozanimod, the proportion of patients experiencing S1P receptor modulator class-related cardiac adverse events, such as bradycardia and conduction abnormalities, was low,” Alessandro Armuzzi, MD, PhD, head of the Inflammatory Bowel Disease Center at Humanitas Research Hospital in Milan, told attendees.
Prior studies have indicated that sphingosine-1-phosphate (S1P) receptor modulators may be linked to bradycardia and atrioventricular conduction delays; however, Armuzzi noted that a previous analysis demonstrated that first-dose Zeposia (ozanimod, Bristol Myers Squibb) had a negligible effect on cardiac function, even among patients with a history of cardiovascular disease.
To establish long-term cardiac safety for continuous ozanimod therapy — specifically a 0.92 mg dose — Armuzzi and colleagues examined data from the phase 3 True North trial in UC and the 12-month SUNBEAM and 24-month RADIANCE trials in MS.
In the True North trial, ECGs were checked at screening, day 1, week 10 and week 52, while patient heart rate was monitored at every visit. In the SUNBEAM and RADIANCE trials, ECGs were similarly observed at screening, day 1, day 15 and at the end of treatment; heart rate was monitored at the start, then at 3-month intervals until the completion of the trial.
“Ozanimod was associated with low incidence and manageable changes in heart rate and blood pressure up to 52 weeks in the True North trial,” Armuzzi said. “Ozanimod was not associated with an increased risk of major adverse cardiovascular events or other serious cardiac side effects.”
Cardiac-related serious adverse events in UC were uncommon: Angina pectoris, coronary artery stenosis, pericarditis was reported in one patient each. Cardiac-related treatment-emergent adverse events were reported in 1.3% of patients with UC in the continuous ozanimod group, with a higher incidence among patients with a prior history of cardiovascular disease (3.5%) vs. those without (0.6%).
Similarly, among MS patients, there were no clinically significant heart rate or ECG changes linked to chronic treatment up to 24 months. The rate of cardiac-related treatment-emergent adverse events also was low, with a comparable incidence among patients with a history of cardiovascular disease (3.5%) vs. those without (3.4%). Serious cardiac-related adverse events were reported in just two patients, with asymptomatic sinus bradycardia and symptomatic supraventricular tachycardia.
“The results were consistent with what is already known in the field,” Armuzzi said. “In both the UC and MS trials, there was a slight increase in mean blood pressure in the ozanimod group with a dose of 0.92, which then stabilized over time. The incidence of cardiovascular treatment-emergent AEs was low in both the ozanimod .92 mg groups for UC and MS.”
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Armuzzi A, et al. Abstract DOP45. Presented at: Congress of European Crohn’s and Colitis Organization; Feb. 16-19, 2022 (virtual meeting).
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