Continued efficacy of long-term ozanimod as UC treatment

Long-term treatment of ozanimod as therapy for ulcerative colitis (UC) did not reveal new safety signals in the True North open-label extension study. Continuous ozanimod treatment for up to 3 years resulted in a sustained response in a considerable number of patients.

The results of the phase 3 True North trial (NCT02435992) have led to the approval of ozanimod as treatment for UC in various countries [1]. The current interim analysis of the True North open-label extension (OLE) trial (NCT02531126) evaluated the efficacy and safety of ozanimod in patients with moderate to severely active UC on about 3 years of continuous ozanimod treatment for efficacy and safety over time. Prof. Silvio Danese (Vita-Salute San Raffaele University, Italy) presented data from 131 OLE patients in clinical response after 52 weeks of ozanimod maintenance [2]. At the cut-off point on 10 January 2022, 87% had completed week 46 and 71.8% had completed week 94 of the OLE.

The efficacy results for weeks 46 and 94 in the “as-observed” population showed rates of 95.9% and 91.4% for clinical response, 72.2% and 69.1% for clinical remission, 77.9% and 73.3% for endoscopic improvement, and 70.1% and 67.9% for steroid-free remission. As expected, the rates in the non-responder-imputation analysis were lower, with a clinical response in 71.0% and 56.5% and steroid-free remission in 51.9% and 42% of the participants at weeks 46 and 94, respectively. “Looking at the course for mean partial Mayo score, you see that there is a very nice drop from induction, and then through the maintenance and the OLE, the course pretty much remains flat, so it means that ozanimod keeps working,” Prof. Danese underlined.

The safety analysis included 433.9 patient-years of exposure to ozanimod. Treatment-emergent adverse events (TEAE) led to discontinuation in 6.1% (n=8) of participants. Within the group with the most frequent TEAEs (≥8%), lymphopaenia, arthralgia, COVID-19, and hypertension were the most common, with an exposure-adjusted incidence rate per 100 patient-years of 5.4, 4.3, 4.0, and 3.9, respectively. “When you look at the infection rates, you can see that the events are very rare; there have been 7 cases of herpes zoster, and when you look at cancer, there have been almost no cases reported,” Prof. Danese elaborated. He indicated that no new safety signals were observed during this long-term exposure investigation.

“These findings provide evidence for long-term durability and tolerability of ozanimod treatment in patients with moderately to severely active UC,” Prof. Danese concluded.

1. Sandborn WJ, et al. N Engl J Med 2021;385(14):1280­–91.
2. Danese S. Efficacy and safety of 3 years of continuous ozanimod treatment: an interim analysis of the True North open-label extension study. DOP37, ECCO 2023, 1–4 March, Copenhagen, Denmark.

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Posted on 4 May, 20234 May, 2023