Abstract

Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension

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

 

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

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