P98 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the true north open-label extension study

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Introduction The phase 3 True North (TN) study (NCT02435992) demonstrated the efficacy and safety of ozanimod (OZA) over 52 wk in patients (pts) with moderately to severely active ulcerative colitis (UC). This interim analysis of the ongoing TN open-label extension (OLE; NCT02531126) assessed pts with up to ~4 y of OZA treatment. Methods Pts in clinical response at Week (W) 52 of OZA treatment during TN who subsequently entered the OLE were analyzed up to OLE W142, representing up to ~4 y of continuous OZA treatment. Symptomatic response and symptomatic remission were evaluated from OLE W5 through OLE W142. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at OLE W46, W94, and W142. Adverse events were monitored throughout TN and the OLE. Results In all, 131 pts entered the OLE after achieving clinical response on OZA at TN W52. At data cutoff, 64.1% completed OLE W142. Symptomatic response and symptomatic remission were observed in 100.0% and 84.4% of pts, respectively, at OLE W5 in observed case (OC) analyses (93.1% and 78.6%, respectively, in nonresponder imputation [NRI] analyses). By OLE W142, symptomatic response and symptomatic remission rates were 98.7% and 88.3%, respectively, in OC analyses (58.0% and 51.9%, respectively, in NRI analyses). Clinical and endoscopic endpoints are shown in figure 1. Of note, 65.3% of TN W52 clinical responders achieved clinical remission and CS-free remission at OLE W142 (OC analyses; 35.9% in NRI analyses). In the last year of follow-up in the OLE, there were no new bradycardia, third-degree atrioventricular block, hypertension, herpes zoster, or macular edema cases, and no clinically meaningful change in malignancy rates. No serious hepatic events occurred. Conclusions Clinical responders after 1 y on OZA sustained response for an additional 3 y and achieved clinical remission with continuous OZA exposure. OZA is a well-tolerated, durable therapy for pts with UC.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.