DOP43 Extended induction in the True North OLE study: ozanimod efficacy in biologic-naive and biologic-experienced patients

Abstract Background Prior exposure to biologics can influence response subsequent lines of advanced therapies. Previous analyses showed that patients who did not achieve clinical following 10 weeks ozanimod treatment in the phase 3 True North (TN) study benefited from extended induction with open-label TN extension (OLE) study. As impact prior biologic on outcomes is unknown, aim this analysis was evaluate question. Methods Clinical nonresponders at Week (W) entered OLE (data cutoff: January 10, 2022, which point disposition available until W94 for all patients). Data were analysed and without baseline. Disease activity assessed W0 (baseline) W10 (OLE entry). Symptomatic remission evaluated through W94, multiple clinical, endoscopic, histologic endpoints W46 using observed case (OC) nonresponder imputation (NRI) analyses. Results A total 220 information after achieving (biologic-naive, n=122; biologic-experienced, n=98). baseline generally consistent between biologic-naive experienced patients. About half both groups achieved symptomatic by W5, a higher proportion maintaining OC NRI (Figure 1). Higher proportions also sustained In analysis, compared biologic-experienced patients; however, consistent, regardless 2). expected, smaller efficacy being rates each group. Conclusion Both -experienced end demonstrated ozanimod. Delayed durable up 2 years continuous groups,