Good safety of ozanimod over up to 8 years of treatment

In a post-hoc analysis of patients with relapsing MS treated with ozanimod 0.92 mg/day for up to over 8 years, the incidence rates of treatment-emergent adverse events (TEAEs) generally declined or remained stable. These results confirm the established safety profile of ozanimod.

DAYBREAK (NCT02576717) is an open-label extension (OLE) trial of ozanimod 0.92 mg/day. The phase 3 parent trials were SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), in which adults with relapsing MS were randomised to ozanimod 0.46 or 0.92 mg/day or IFN-β1a 30 µg/week for ≥12 months and 24 months, respectively. Prof. Krzysztof Selmaj (University of Warmia and Mazury, Poland) presented the safety patterns in participants who were exposed to continuous ozanimod for up to more than 8 years [1].

The total DAYBREAK safety population consisted of 2,256 participants, with a mean treatment duration of 73.1 months. For the continuous ozanimod population of 762 participants, the mean exposure was 80.1 months. Of the total safety population, 84 participants (3.4%) discontinued ozanimod treatment due to adverse events. Incidence rates were calculated for overall TEAEs, serious TEAEs, and TEAEs of special interest during the pooled phase 3 trials and at yearly intervals during the OLE.

The proportion of participants who experienced TEAEs or serious TEAEs in the OLE trial decreased or remained stable over time (see Figure). TEAEs of special interest, including malignancies and cardiac, pulmonary, and hepatic TEAEs, remained stable or decreased over time.

Figure: Overall TEAEs and serious TEAEs in the continuous ozanimod population and the total safety population [1]



TEAEs, treatment-emergent adverse events.

Looking at specific adverse events, the incidence rate for non-melanoma skin cancers decreased from the parent trials through the OLE in the overall OLE population: the estimated age-standardised incidence rate of non-melanoma skin cancers ranged from 22.1 to 795.7 per 100,000 patient-years (PY) in the parent trials and an incidence rate of 102.9 per 100,000 PY in DAYBREAK.

Elevations of 3x the upper limit of normal (ULN) of alanine aminotransferase, aspartate aminotransferase, and bilirubin were rare; elevations of 3x ULN of alanine aminotransferase became more infrequent as the OLE progressed. There were no cases of severe drug-induced liver injury. In the overall OLE trial, there were only a few confirmed macular oedema cases: 1 case in the continuous ozanimod 0.92 mg group and 5 cases in the total OLE population.

1. Selmaj KW, et al. Safety patterns over up to 8 years with ozanimod in patients with relapsing multiple sclerosis: final results from the DAYBREAK Open-label Extension Study. P1609, ECTRIMS 2024, 18–20 September, Copenhagen, Denmark.

 

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Posted on 18 November 202419 November 2024