P0675 - 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

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Presenting Author(s)

Anita Afzali, MD, MPH, FACG

Executive Vice Chair of Internal Medicine, Interim Division Director of Digestive Diseases, Associate Chief Medical Officer
University of Cincinnati College of Medicine
Cincinnati, OH

Anita Afzali, MD, MPH, FACG¹, David T. Rubin, MD², Maria T. Abreu, MD³, Michael V.. Chiorean, MD⁴, Lucy Akukwe, PharmD, MS⁵, Anjali Jain, PhD⁵, AnnKatrin Petersen, MD⁵, Mark T. Osterman, MD, PhD⁵, Hsiuanlin Wu, MS⁵, Silvio Danese, MD, PhD⁶, Remo Panaccione, MD⁷
¹University of Cincinnati College of Medicine, Cincinnati, OH; ²Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; ³University of Miami Miller School of Medicine, Miami, FL; ⁴Inflammatory Bowel Disease Center, Swedish Medical Center, Seattle, WA; ⁵Bristol Myers Squibb, Princeton, NJ; ⁶IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy; ⁷University of Calgary, Calgary, AB, Canada

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 with UC who achieved clinical response at TN Week (W) 52.

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 patients entered the OLE as TN W52 clinical responders on continuous OZA therapy; of these patients, 63% (83/131) were clinical remitters. All patients 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).

Discussion: Most patients 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 patients with moderately to severely active UC.

	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)

Table. OZA efficacy at OLE W46 and OLE W94 in TN W52 clinical responders with or without clinical remission (OC analysis).

Note: Denominators for the OC analyses were based on the numbers of patients 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.

Disclosures:

Anita Afzali: AbbVie – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Bristol Myers Squibb/Celgene – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. DiaSorin – Consultant. Eli Lilly – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Gilead – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. IBD Horizons – Owner/Ownership Interest. Janssen – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Takeda – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. TLL Pharmaceuticals – Consultant.

David Rubin: AbbVie – Consultant, personal fees. AltruBio – Consultant, personal fees. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Corp/Syneos – Consultant. Eco R1 – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, personal fees. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant, personal fees. Kaleido Biosciences – Consultant. Lilly – Consultant. Pfizer – Consultant, personal fees. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant, personal fees. Seres Therapeutics – Consultant. Takeda – Consultant, Grant/Research Support, Personal fees. Target RWE – Consultant. Trellus Health – Consultant.

Maria T. Abreu: AbbVie – Advisory Committee/Board Member, Consultant. Alimentiv – Speakers Bureau. Amgen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Arena – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celsius Therapeutics – Advisory Committee/Board Member, Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant. Gilead Sciences – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Microba Life Sciences, – Advisory Committee/Board Member, Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Prometheus Biosciences – Advisory Committee/Board Member, Consultant. Takeda – Speakers Bureau. UCB Biopharma – Advisory Committee/Board Member, Consultant. WebMD Global – Advisory Committee/Board Member, Consultant.

Michael Chiorean: AbbVie – Consultant, Speakers Bureau. Bristol Myers Squibb – Consultant, Speakers Bureau. Eli Lilly – Consultant. Fresenius Kabi – Consultant, Speakers Bureau. Fuji – Grant/Research Support. Gilead – Grant/Research Support. Janssen – Consultant, Grant/Research Support, Speakers Bureau. Novartis – Grant/Research Support. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau.

Lucy Akukwe: Bristol Myers Squibb – employee and/or shareholder.

Anjali Jain: Bristol Myers Squibb – employee and/or shareholder.

AnnKatrin Petersen: Bristol Myers Squibb – employee and/or shareholder.

Mark T. Osterman: Bristol Myers Squibb – employee and/or shareholder.

Hsiuanlin Wu: Bristol Myers Squibb – employee and/or shareholder.

Silvio Danese: AbbVie – Consultant, personal fees (lecture fees). Alimentiv – Consultant. Allergan – Consultant, personal fees. Amgen – Consultant, lecture fees. Applied Molecular Transport – Consultant. AstraZeneca – Consultant, personal fees. Athos Therapeutics – Consultant, personal fees. Biogen – Consultant, personal fees. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene – Consultant, personal fees. Celltrion Healthcare – Consultant, Personal fees. Dr Falk Pharma – Consultant. Eli Lilly – Consultant, personal fees. Enthera – Consultant, personal fees. Ferring Pharmaceuticals – Consultant, lecture fees. Gilead – Consultant, lecture fees. Hospira – Consultant, personal fees. Inotrem – Consultant, personal fees. Janssen Pharmaceuticals – Consultant, lecture fees. Johnson & Johnson – Consultant, personal fees. Morphic – Consultant. MSD – Consultant, personal fees. Mundipharma – Consultant, personal fees. Mylan – Consultant, lecture fees. Pfizer – Consultant, lecture fees. Roche – Consultant, personal fees. Sandoz – Consultant, personal fees. Sublimity Therapeutics – Consultant, personal fees. Takeda – Consultant, lecture fees. Teladoc Health – Consultant. TiGenix – Consultant, personal fees. UCB – Consultant, personal fees. Vial – Consultant. Vifor – Consultant, personal fees.

Remo Panaccione: Abbivax – Consultant. Abbott – Consultant. AbbVie – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena – Consultant. AstraZeneca – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion – Consultant. Cosmos Technology – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. JAMP Bio – Consultant. Janssen – Consultant. Merck – Consultant. Mylan – Consultant. Novartis – Consultant. Oppilan Pharma – Consultant. Organon – Consultant. Pandion Pharma – Consultant. Pendopharm – Consultant. Pfizer Inc – Consultant. Progenity – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant. Sandoz – Consultant. Satisfai Health – Consultant. Shire – Consultant. Sublimity Therapeutics – Consultant. Takeda Pharmaceuticals – Consultant. Theravance Biopharma – Consultant. Trellus – Consultant. UCB – Consultant. Ventyx – Consultant. Viatris – Consultant.