J Crohns Colitis. 2024 Feb 26;18(2):264-274. doi: 10.1093/ecco-jcc/jjad146.

Silvio Danese ¹, Remo Panaccione ², Maria T Abreu ³, David T Rubin ⁴, Subrata Ghosh ⁵, Axel Dignass ⁶, Anita Afzali ⁷, Douglas C Wolf ⁸, Michael V Chiorean ⁹, Severine Vermeire ¹⁰, Anjali Jain ¹¹, Lorna Charles ¹², Garrett Lawlor ¹³, Mark T Osterman ¹⁴, Hsiuanlin Wu ¹⁵, James B Canavan ¹⁶, AnnKatrin Petersen ¹⁷, Jean-Frederic Colombel ¹⁸, Miguel Regueiro ¹⁹

Author information

¹Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.

²Inflammatory Bowel Disease Unit, Gastrointestinal Research, Inflammatory Bowel Disease Clinic, Calgary, AB, Canada.

³Crohn's & Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA.

⁴Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Inflammatory Bowel Disease Center, Chicago, IL, USA.

⁵University College Cork, Cork, Ireland.

⁶Department of Medicine, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.

⁷University of Cincinnati College of Medicine, Cincinnati, OH, USA.

⁸Internal Medicine and Gastroenterology, Atlanta Gastroenterology Associates LLC, Atlanta, GA, USA.

⁹Inflammatory Bowel Disease Center, Swedish Gastroenterology, Issaquah, WA, USA.

¹⁰Department of Chronic Diseases & Metabolism, University of Leuven, Leuven, Belgium.

¹¹Translational Sciences and Medical Affairs, Bristol Myers Squibb, Princeton, NJ, USA.

¹²Worldwide Patient Safety, Bristol Myers Squibb, Princeton, NJ, USA.

¹³GI Medicine, US Medical Affairs I&F, Bristol Myers Squibb, Princeton, NJ, USA.

¹⁴Disease Area Head, Gastroenterology, Bristol Myers Squibb, Princeton, NJ, USA.

¹⁵Statistician, Bristol Myers Squibb, Princeton, NJ, USA.

¹⁶Bristol Myers Squibb, Princeton, NJ, USA.

¹⁷Clinical Research at Celgene, Bristol Myers Squibb, Princeton, NJ, USA.

¹⁸Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

¹⁹Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA.

Abstract

Backgrounds and aims: This interim analysis from the True North open-label extension [OLE] study examines efficacy and safety of approximately 3 years of continuous ozanimod treatment in patients with moderately to severely active ulcerative colitis.

Methods: Clinical responders after 52 weeks of ozanimod during the phase 3 True North study, who continued treatment in the OLE, were evaluated. Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses. Adverse events were monitored from True North baseline through OLE data cutoff and expressed as exposure-adjusted incidence rates.

Results: This analysis included 131 patients; 54% had achieved corticosteroid-free remission at True North Week 52. In OC analyses, clinical response, clinical remission, and corticosteroid-free remission were achieved by 91.4%, 69.1%, and 67.9% of patients, respectively, at OLE Week 94 [146 weeks of total treatment]. Similarly, endoscopic improvement, histological remission, and mucosal healing were achieved by 73.3%, 67.3%, and 56.3% of patients, respectively, at OLE Week 94. Efficacy rates were lower using NRI analyses, but maintenance of efficacy was demonstrated through OLE Week 94. No new safety signals emerged from this analysis. Serious infections, malignancy, cardiovascular events, and hepatic events occurred infrequently.

Conclusions: Among patients who achieved clinical response after 1 year of ozanimod treatment during True North, a high percentage sustained clinical and mucosal efficacy over 2 additional years in the OLE. No new safety signals were observed with long-term ozanimod use.