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Sunday Poster Session

Category: IBD

P0717 - Effects of Early Mucosal Healing at Week 10 Using Stringent Criteria in Patients With Ulcerative Colitis Treated With Ozanimod on Clinical Outcomes at Week 52

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
Has Audio
Jordan Axelrad, MD, MPH1, Ailsa Hart, BMBCh, PhD2, Charles Sninsky, MD3, Raymond K.. Cross, MD, MS, FACG4, Harris A. Ahmad, MD5, Anjali Jain, PhD5, Hsiuanlin Wu, MS5, Mark T. Osterman, MD, PhD5, Randy Longman, MD, PhD6, Walter Reinisch, MD7
1NYU Grossman School of Medicine, New York, NY; 2St. Mark’s Hospital & Imperial College, London, England, United Kingdom; 3Digestive Disease Associates, Gainesville, FL; 4University of Maryland School of Medicine, Baltimore, MD; 5Bristol Myers Squibb, Princeton, NJ; 6Weill Cornell Medical College, New York, NY; 7Medical University of Vienna, Vienna, Wien, Austria

Introduction: Ozanimod (OZA) is approved in multiple countries for the treatment (tx) of moderately to severely active ulcerative colitis (UC). Mucosal healing (MH), a key tx goal for patients (pts) with UC, is associated with improved long-term pt outcomes.

Methods: This analysis was performed to determine the rate of early MH after OZA tx at Week (W) 10 using stringent MH criteria (mucosal endoscopy subscore [MES] = 0 plus histologic remission [HR; Geboes score < 2.0]) and to assess the relationship between achievement of stringent MH at W10 and clinical outcomes at W52. Outcomes were compared to pts achieving MH using a standard definition (MES ≤1 plus HR). Pts from True North (NCT02435992) who achieved clinical response on oral OZA 0.92 mg at W10 and continued OZA during the 42-wk maintenance period were included in this post hoc analysis. MH, clinical remission, and corticosteroid (CS)–free remission at W52 at W10 were compared in pts with stringent MH vs pts without stringent MH, and vs pts with standard MH.

Results: Of 230 pts who achieved clinical response on OZA at W10 and continued OZA during the maintenance period, 44 (19.1%) achieved standard MH and 13 (5.7%) achieved stringent MH at W10. Demographic and clinical characteristics were generally balanced between OZA-treated pts with stringent MH (n=13) and without stringent MH (n=217) at W10, except there were fewer male pts with stringent MH, all pts with stringent MH had moderate disease, and more pts with stringent MH had left-sided UC disease. CS use at screening and prior tumor necrosis factor inhibitor (TNFi) use were lower in those with stringent MH vs without stringent MH. Similar patterns in disease severity, extent of disease, and CS and TNFi use were seen in pts with stringent MH vs standard MH. At W52, more OZA-treated pts with stringent MH at W10 vs without stringent MH at W10 had clinical remission (53.8% vs 35.9%), CS-free remission (53.8% vs 30.4%), MH (61.5% vs 27.6%), endoscopic improvement (61.5% vs 44.7), and HR (61.5% vs 31.8%). Except for endoscopic improvement, slightly more pts with stringent MH vs standard MH at W10 achieved clinical outcomes at W52 (Table).

Discussion: A small proportion of OZA-treated pts achieved stringent MH by W10. Compared with pts who achieved standard MH at W10, those with stringent MH at W10 demonstrated numerically better clinical outcomes at W52 on OZA tx. Achievement of stringent MH at W10 was associated with good clinical, endoscopic, and mucosal outcomes at W52.

W52 outcome, n (%)

With stringent MH (MES=0 and Geboes score < 2.0) at W10

(n=13)

With standard MH (MES ≤1 and Geboes score < 2.0) at W10

(n=44)

Without stringent MH (MES >0 and/or Geboes score ≥2.0) at W10

(n=217)

Clinical remissiona

7 (53.8)

21 (47.7)

78 (35.9)

CS-free clinical remissionb

7 (53.8)

20 (45.5)

66 (30.4)

MHc

8 (61.5)

23 (52.3)

60 (27.6)

Endoscopic improvementd

8 (61.5)

28 (63.6)

97 (44.7)

Histologic remissione

8 (61.5)

25 (56.8)

69 (31.8)

 

Table. Clinical outcomes at W52.

aRBS=0, SFS ≤1 (plus a ≥1-point reduction from baseline), and MES ≤1. bRemission with no CS use for ≥12 wk. cMES ≤1 and Geboes score < 2.0. dMES ≤1. eGeboes score < 2.0.

RBS, rectal bleeding subscore; SFS, stool frequency subscore.



Disclosures:
Jordan Axelrad: AbbVie – received consulting fees. Adiso – received consulting fees. BioFire Diagnostics – Consultant, Grant/Research Support. Bristol Myers Squibb – received consulting fees. Fresenius Kabi – received consulting fees. Janssen – received consulting fees. Pfizer – received consulting fees.
Ailsa Hart: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau. Atlantic Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Falk – Advisory Committee/Board Member, Consultant, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Genentech – Global Steering Committee. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Advisory Committee/Board Member, Consultant, Speakers Bureau. Napp Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Shire – Advisory Committee/Board Member, Consultant, Speakers Bureau. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau.
Charles Sninsky: AbbVie – Speakers Bureau. Bristol Myers Squibb – Speakers Bureau. Janssen – Speakers Bureau. Pfizer – Speakers Bureau. Takeda – Speakers Bureau. UCB – Speakers Bureau.
Raymond Cross: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Janssen – Consultant. LabCorp – Consultant. Pfizer – Consultant. Samsung Bioepis – Consultant. Takeda – Consultant.
Harris A. Ahmad: Bristol Myers Squibb – employee and/or shareholder.
Anjali Jain: Bristol Myers Squibb – employee and/or shareholder.
Hsiuanlin Wu: Bristol Myers Squibb – employee and/or shareholder.
Mark T. Osterman: Bristol Myers Squibb – employee and/or shareholder.
Randy Longman: enzymetrics – Consultant. Pfizer – Consultant.
Walter Reinisch: 4SC – Advisory Committee/Board Member, Speakers Bureau. Abbott Laboratories – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Aesca – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Algernon – Consultant. AM Pharma – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. AMT – Consultant. AOP Orphan – Consultant. Aptalis – Speakers Bureau. Arena – Consultant. Astellas – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Advisory Committee/Board Member, Consultant. Avaxia – Advisory Committee/Board Member, Consultant. Bioclinica – Consultant. Biogen IDEC – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Calyx – Consultant. Celgene – Advisory Committee/Board Member, Consultant. Cellerix – Advisory Committee/Board Member, Consultant. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Centocor – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. ChemoCentryx – Advisory Committee/Board Member, Consultant. Covance – Consultant. Danone Austria – Advisory Committee/Board Member, Consultant, Speakers Bureau. DSM – Advisory Committee/Board Member, Consultant. Elan – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Consultant. Ernst & Young – Consultant. Falk Pharma GmbH – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Fresenius – Consultant. Galapagos – Advisory Committee/Board Member, Consultant. Gatehouse Bio – Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Consultant. Grünenthal – Advisory Committee/Board Member, Consultant. ICON – Consultant. Immundiagnostik – Grant/Research Support, Speakers Bureau. Index Pharma – Consultant. Inova – Advisory Committee/Board Member, Consultant. Intrinsic Imaging – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support. Johnson & Johnson – Advisory Committee/Board Member, Consultant. Kyowa Hakko Kirin Pharma – Advisory Committee/Board Member, Consultant. Landos – Consultant. Lipid Therapeutics – Advisory Committee/Board Member, Consultant. LivaNova – Consultant. Mallinckrodt – Consultant. Medahead – Consultant. Medice – Speakers Bureau. MedImmune – Advisory Committee/Board Member, Consultant. Millenium – Advisory Committee/Board Member, Consultant. Mitsubishi Tanabe Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Nash Pharmaceuticals – Consultant. Nestle – Advisory Committee/Board Member, Consultant. Nippon Kayaku – Consultant. Novartis – Advisory Committee/Board Member, Consultant. Ocera – Advisory Committee/Board Member, Consultant. OMass – Consultant. Otsuka – Advisory Committee/Board Member, Consultant, Speakers Bureau. Parexel – Consultant. PDL – Advisory Committee/Board Member, Consultant, Speakers Bureau. Peri Consulting – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Philip Morris Institute – Consultant. PLS Education – Speakers Bureau. Procter and Gamble – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. Provention – Consultant. Quell Therapeutics – Consultant. Robarts Clinical Trial – Consultant. Roland Berger GMBH – Consultant. Sandoz – Advisory Committee/Board Member, Consultant, Grant/Research Support. Schering-Plough – Advisory Committee/Board Member, Consultant, Speakers Bureau. Second Genome – Advisory Committee/Board Member, Consultant. Seres – Consultant. Setpoint Medical – Advisory Committee/Board Member, Consultant. Shire – Speakers Bureau. Sigmoid – Consultant. Sublimity – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Teva – Consultant. Therakos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Consultant. TiGenix – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant. Vifor – Consultant, Speakers Bureau. Yakult – Speakers Bureau. Zealand – Advisory Committee/Board Member, Consultant. Zygenia – Advisory Committee/Board Member, Consultant.


Jordan Axelrad, MD, MPH1, Ailsa Hart, BMBCh, PhD2, Charles Sninsky, MD3, Raymond K.. Cross, MD, MS, FACG4, Harris A. Ahmad, MD5, Anjali Jain, PhD5, Hsiuanlin Wu, MS5, Mark T. Osterman, MD, PhD5, Randy Longman, MD, PhD6, Walter Reinisch, MD7. P0717 - Effects of Early Mucosal Healing at Week 10 Using Stringent Criteria in Patients With Ulcerative Colitis Treated With Ozanimod on Clinical Outcomes at Week 52, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.