After up to 3 years of ozanimod for UC, the benefit of treatment was maintained in many patients, with no unexpected events during this period.
The interim analysis of the phase 3 True North open-label extension (OLE) trial evaluated patients with moderate to severe active ulcerative colitis (UC) on about 3 years of continuous ozanimod treatment for efficacy and safety over time. Silvio Danese, MD, PhD, of Vita-Salute San Raffaele University, presented data on 131 OLE patients in clinical response after 52 weeks of ozanimod maintenance. At the cut-off point, 87% had completed week 46 and 71.8% had completed week 94 of the OLE.
The efficacy results for week 46 and 94 in the “as observed” population show 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, respectively. 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% at weeks 46 and 94, respectively. “Looking at the course for mean partial Mayo score, you see that from induction there is a very nice drop and then through the maintenance and the OLE, the course pretty much remains flat, so it means that ozanimod keeps working,” Dr. Danese noted.
The safety analysis included 433.9 patient years of ozanimod exposure. Treatment-emergent adverse events (TEAE) led to discontinuation in 6.1% of patients (N=8). Within the group of the most frequent TEAEs (≥8%), lymphopenia, arthralgia, COVID-19, and hypertension were the most common, with an exposure-adjusted incidence rate per 100 patient years of 5.4 for lymphopenia, 4.3 for arthralgia, 4.0 for COVID-19, and 3.9 for hypertension. “When you look at the infection rates, you can see that the events are very rare. There have been seven cases of herpes zoster. When you look at cancer, there have been almost no cases reported,” Dr. 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 moderate to severely active UC,” Dr. Danese said.
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