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LONG-TERM CLINICAL AND ENDOSCOPIC OUTCOMES IN TRUE NORTH WEEK 52 CLINICAL REMITTERS OVER 3 YEARS OF TREATMENT WITH OZANIMOD: AN INTERIM ANALYSIS OF THE TRUE NORTH OPEN-LABEL EXTENSION STUDY

Remo Panaccione 1, David T. Rubin 2, Maria T. Abreu 3, Michael Chiorean 4, Lucy Akukwe 5, Anjali Jain 5, AnnKatrin Petersen 5, Mark Osterman 5, Hsiuanlin Wu 5, Silvio Danese 6, Anita Afzali 7

Affiliations

1 Inflammatory Bowel Disease Clinic, Calgary, Alberta, Canada

2 University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, United States

3 University of Miami Miller School of Medicine, Miami, United States

4 Swedish Medical Center, Seattle, United States

5 Bristol Myers Squibb, Princeton, United States

6 Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy

7 Division of Digestive Diseases, University of Cincinnati, Cincinnati, United States

Summary

AI Generated

Interim analysis of the True North open-label extension demonstrates sustained efficacy of ozanimod over 146 weeks in ulcerative colitis patients who achieved clinical response at week 52, with higher efficacy rates in those who achieved remission.

Among 131 patients entering the open-label extension as week-52 clinical responders on continuous ozanimod, 63% were in clinical remission and these clinical remitters achieved higher rates of efficacy outcomes at weeks 46 and 94 than nonremitters.
At open-label extension week 94, clinical remitters achieved clinical remission in 94.4% of cases, clinical response in 75.9%, endoscopic improvement in 78.6%, and corticosteroid-free remission in 74.1%.
Clinical nonremitters at week 52 achieved lower but still substantial efficacy at week 94: clinical remission 85.2%, clinical response 55.6%, endoscopic improvement 63.3%, and corticosteroid-free remission 55.6%.
Durability of response from week 46 to week 94 was maintained in most patients across all efficacy endpoints, ranging from 66% to 80% depending on endpoint and remission status.
Clinical remitters had lower prior TNF inhibitor use (25.3%) compared with nonremitters (43.8%), though baseline demographics and disease characteristics were otherwise generally similar between groups.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Ozanimod (OZA), a selective sphingosine 1-phosphate receptor modulator, is approved for the treatment of moderately to severely active ulcerative colitis (UC) based on results from the phase 3 True North (TN) study, which demonstrated the efficacy and safety of OZA over 52 weeks. A subsequent post hoc analysis demonstrated the durability of OZA efficacy and favorable safety profile of OZA over 3 years during the ongoing TN OLE in patients (pts) with UC who achieved clinical response at TN Week (W) 52.

Aims & Methods

The present interim analysis of the TN OLE expands the evaluation of TN W52 clinical responders to include those who achieved clinical remission at TN W52 (ie, clinical remitters) vs those who did not (ie, clinical nonremitters) before entering the TN OLE. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)–free remission were evaluated in TN W52 clinical remitters vs nonremitters at OLE W46 and OLE W94 using observed case (OC) and nonresponder imputation (NRI) analyses.

Results

In all, 131 pts entered the OLE as TN W52 clinical responders on continuous OZA therapy; of these pts, 63% (83/131) were clinical remitters. All pts had received 146 weeks of continuous OZA treatment up to OLE W94 or discontinued treatment. TN baseline demographic and disease characteristics were generally similar between the 2 groups, but a lower incidence of prior tumor necrosis factor (TNF) inhibitor use was reported in clinical remitters (25.3% [21/83]) vs clinical nonremitters (43.8% [21/48]); prior non–anti-TNF biologic use was similar between groups. Compared with clinical nonremitters, more clinical remitters achieved the evaluated efficacy endpoints at OLE W46 and OLE W94 in the OC analysis (Table). A similar trend was observed in the NRI analysis. Durability of response for all efficacy endpoints was sustained from OLE W46 to OLE W94 in most clinical remitters and nonremitters, respectively: 68.5% (37/54) and 75.0% (12/16); clinical response: 75.0% (48/64) and 75.9% (22/29); endoscopic improvement: 66.1% (41/62) and 68.4% (13/19); and CS-free remission: 67.9% (36/53) and 80.0% (12/15).

OZA efficacy at OLE W46 and OLE W94 in TN W52 clinical responders with or without clinical remission (OC analysis)
	Clinical remitters at TN W52 (n=83)		Clinical nonremitters at TN W52 (n=48)
	OLE W46	OLE W94	OLE W46	OLE W94
Clinical remission,^a % (n/N)	97.0 (64/66)	94.4 (51/54)	93.5 (29/31)	85.2 (23/27)
Clinical response,^b % (n/N)	81.8 (54/66)	75.9 (41/54)	51.6 (16/31)	55.6 (15/27)
Endoscopic improvement,^c % (n/N)	86.1 (62/72)	78.6 (44/56)	59.4 (19/32)	63.3 (19/30)
CS-free remission,^d % (n/N)	80.3 (53/66)	74.1 (40/54)	48.4 (15/31)	55.6 (15/27)
Note: Denominators for the OC analyses were based on the numbers of pts who completed OLE W46 or OLE W94 and had data available for the endpoints in question. ^aClinical remission: RBS=0 point and SFS ≤1 point, a decrease of ≥1 point from the baseline SFS, and endoscopy subscore ≤1 point. ^bClinical response: reduction from baseline in the 9-point Mayo score (sum of the RBS, SFS, and endoscopy subscore) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point. ^cEndoscopic improvement: endoscopy subscore of ≤1. ^dCS-free remission: clinical remission while off CS for ≥12 weeks.RBS, rectal bleeding subscore; SFS, stool frequency subscore.

Conclusion

Most pts who achieved clinical remission after 1 year of OZA had sustained efficacy for an additional 2 years of continuous OZA treatment. These findings provide further evidence for the long-term durability of OZA treatment in pts with moderately to severely active UC.

Disclosure

This study was funded by Bristol Myers Squibb, Princeton, NJ, USA.
RP: received consulting fees from Abbott, AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Therapeutics, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Schering-Plough, Shire, Sublimity Therapeutics, Theravance, UCB, and Takeda; received speaker fees from AbbVie, Arena, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda; received research/educational support from AbbVie, Ferring, Janssen, Pfizer, and Takeda; served on an advisory board for AbbVie, Amgen, Arena, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Takeda, and Theravance.
DTR: received grant support from Takeda; consulted for AbbVie, AltruBio, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chronicles, ClostraBio, Connect BioPharma, EcoR1, Eli Lilly, Genentech/Roche, Gilead Sciences, Iterative Health, Janssen, Kaleido Biosciences, Pfizer, Prometheus Biosciences, Reistone, Seres Therapeutics, Syneos, Takeda, Target RWE, and Trellus Health.
MTA: consulted or participated in advisory board for AbbVie, Amgen, Arena, Bristol Myers Squibb, Celsius Therapeutics, Eli Lilly, Gilead Sciences, Janssen, Microba Life Sciences, Pfizer, Prometheus Biosciences, UCB Biopharma, and WebMD Global; reported teaching, lecturing, or speaking for Alimentiv, Amgen, Janssen, and Takeda.
MVC: reported advisory/consulting roles with AbbVie, Arena, Bristol Myers Squibb, Eli Lilly, Janssen, Medtronic, and Pfizer; reported speaker role with AbbVie, Bristol Myers Squibb, Janssen, Medtronic, and Pfizer; received research funding from Fuji, Gilead, Janssen, Novartis, Pfizer, and Takeda.
LA, AJ, AP, MTO, and HW: employees and/or shareholders of Bristol Myers Squibb.
SD: received honoraria as a speaker, consultant, and/or advisory board member from AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor.
AA: served as a consultant for AbbVie, Bristol Myers Squibb, DiaSorin, Eli Lilly, Gilead, Janssen, Pfizer, Takeda, and TLL Pharmaceuticals; received speaker fees from AbbVie, Bristol Myers Squibb, Janssen, Pfizer, and Takeda.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Targeting immune cell trafficking in IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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ROME V GLOBAL EPIDEMIOLOGY SURVEY

Ami D. Sperber 1, Jóhann Hreinsson 2, Magnus Simrén 3, Douglas Drossman 4, Viola Andresen 5, Serhat Bor 6, Dan Lucian Dumitrascu 7, Xiucai Fang 8, Guijun Fei 8, Luis Bustos Fernandez 9, Carlos de Magalhaes Francisconi 10, Shin Fukudo 11, Sang-Kil Lee 12, Chloé Melchior 13, Agata Mulak 14, Anne Peery 15, David Mario Rodrigues 16, Javier Santos 17, Max Julio Schmulson Wasserman 18, Dipesh H Vasant 19, Jan Tack 20, Olafur S. Palsson 21

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1 Ben-Gurion University of the Negev, Beer-Sheva, Israel

2 Sahlgrenska University Hospital, Gothenburg, Sweden

3 Sahlgrenska University Hospital - Dept of Internal Medicine, Sahlgrenska University Hospital ; Gothe, Gothenburg, Sweden

4 Drossman Gastroenterology - Drossman Gastroenterology, Drossman Gastroenterology; Chapel Hill/US, Chapel Hill, United States

5 Israelitisches Krankenhaus Hamburg/DE, Hamburg, Germany

6 Ege University Dept of Gastroenterology Ege Reflux Study Group, Izmir, Türkiye

7 Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania

8 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

9 CMBF, Buenos Aires, Argentina

10 Hospital de Clínicas Porto Alegre Dept. of Gastroenterology, Porto Alegre, Brazil

11 Tohoku University Graduate School of Medicine, Sendai, Japan

12 Yonsei University College of Medicine, Severance Hospital, Seoul, Korea, Republic of

13 Rouen University Hospital, INSERM U1073, CIC-CRB-1404, Rouen, France

14 Katedra I Klinika Gastroenterologii I Hepatologii Uniwersytet Medyczny Wroclaw, Wroclaw, Poland

15 University of North Carolina at Chapel Hill, Chapel Hill, United States

16 Queen's University, Kingston, ON, Canada

17 Institut de Recerca Vall d`Hebron, Barcelona, Spain

18 Dr. Ruy Pérez Tamayo (UME), Faculty of Medicine, Universidad Nacional Autónoma de Mexico (UNAM). Hospital General de México, Mexico City, Mexico

19 Manchester University Foundation Trust, Manchester, United Kingdom

20 University of Leuven, University Hospital Gasthuisberg, Leuven, Belgium

21 University of North Carolina, Chapel Hill, Chapel Hill, NC, United States