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Ozanimod has long-term tolerability, safety, and efficacy for relapsing multiple sclerosis management.
A long-term extension of Ozanimod trials illustrated that in multiple sclerosis patients, Ozanimod (a sphingosine 1-phosphate receptor 1 and 5 modulator) was safe, well-tolerated, and exhibited sustained benefit on clinical and magnetic resonance imaging markers of disease activity. Researchers aimed to describe the long-term effectiveness and safety of Ozanimod for multiple sclerosis.
People with relapsing multiple sclerosis who finished a phase 1‒3 ozanimod trial had eligibility for
the open-label extension study (DAYBREAK) with Ozanimod 0.92 mg/day. With a mean exposure to Ozanimod of 46.8 (standard deviation 11.9; range 0.033–62.7) months in DAYBREAK, 2494 subjects were incorporated in the analysis.
Treatment-emergent adverse events (TEAEs; identical to the ones in parent trials) occurred in 2143 patients (85.9%) during DAYBREAK, 298 (11.9%) of whom experienced major TEAE, and 75 (3.0%) of whom terminated the therapy as a result of TEAEs. There were a few serious infections (2.8%), cardiac TEAEs (2.8%), instances of verified macular edema (0.2%), and herpes zoster infections (1.7%).
The adjusted annualized relapse rate was 0.103. Overall, 71% of patients were relapse-free over 48 months. Adjusted mean numbers of novel/enlarging T2 scan/lesions and gadolinium-enhancing lesions were both infrequent and comparable across subgroups of parent trial therapy. Hence, Ozanimod use was associated with sustained control of disability progression and disease activity in multiple sclerosis patients.
Multiple Sclerosis Journal
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
Bruce AC Cree et al.
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