The Safety Data of Ozanimod in Multiple Sclerosis


Krzysztof Selmaj, MD, PhD, presents the results of a pooled safety study of ozanimod as treatment for relapsing-remitting multiple sclerosis (RRMS).


Krzysztof Selmaj, MD, PhD: There were studies on the safety issues in the development program of ozanimod, starting with phase 2 and phase 3 programs, RADIANCE and SUNBEAM, and also from the open-extension study, which patients entered after completion of the phase 3 programs. Altogether, we have data from 7 years of observation today, and we have close to 2500 patients in this observational cohort. All the adverse effects I mentioned—cardiovascular, infections, liver, macular edema—all these showed diminishing tendency over time. And all these events occurred at a relatively low level. I would like to point specifically to the measurement of liver function, because ozanimod showed a modest effect on the liver compared to other S1P [sphingosine-1-phosphate] receptor modulators. For example, in this 7-year observation period, the increase in ALT [alanine transaminase levels] above 3 times the upper limit of normal occurred only in 3.6% [of patients]. Whereas for the other modulators, these figures were much higher. Also importantly, in time there was a diminished effect of an increased level of transaminases. With time, there were also decreases in all the other parameters that can be linked with ozanimod. Basically, we can say that the pattern of safety was modest.

I can be a bit more specific about this ozanimod study. There were no new safety signals that would point to something happening or some new development. The increase in hepatic enzymes were typically asymptomatic and low. For example, for an increase of 5 times [the upper limit of normal], it was only 1.6% [of patients]. That was significantly lower than for other modulators. Macular edema [adverse effects] were very rare, occurring at a rate of 0.3%, also lower compared with previous observations. Only 7% of patients treated with ozanimod had a lymphocyte count below 0.2, and even these lower levels of lymphocytes were not associated with increased risk of infections, which is important. Another important thing was that there was no increase in malignancies. The malignancies that occurred were expected for patients with MS [multiple sclerosis], according to the age and sex distribution. There were no malignancies that would predominate or occur at a higher frequency. For malignancies, the drug was very safe, and also were no problems with skin cancer. The safety profile for ozanimod, which was proven with this 7 years of observation, was very modest.

In the clinical trial, the lower dose was 0.4 to 0.6 mg, and 0.92 mg was also used as the higher dose. But for the marketing for the profile, only the higher dose was used. The data I gave you on the safety, all these data were related to this higher dose, which was FDA approved. The lower dose was not much different from the approved dose, it’s just not in use. We don’t need to discuss the safety profile for the lower dose because we’re not using it.

Transcript edited for clarity.

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