P0716 - Impact of Prior Biologic Exposure on the Long-Term Durability of Clinical and Mucosal Efficacy in Patients With Ulcerative Colitis Treated With Ozanimod

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Jordan E. Axelrad, MD, MPH

NYU Grossman School of Medicine
New York, NY

Jordan Axelrad, MD, MPH¹, Maia Kayal, MD², Ailsa Hart, BMBCh, PhD³, Charles Sninsky, MD⁴, Raymond K.. Cross, MD, MS, FACG⁵, Dimpy Mehra, PharmD⁶, Hsiuanlin Wu, MS⁶, Mark T. Osterman, MD, PhD⁶, Harris A. Ahmad, MD⁶, Anjali Jain, PhD⁶, Walter Reinisch, MD⁷
¹NYU Grossman School of Medicine, New York, NY; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³St. Mark’s Hospital & Imperial College, London, England, United Kingdom; ⁴Digestive Disease Associates, Gainesville, FL; ⁵University of Maryland School of Medicine, Baltimore, MD; ⁶Bristol Myers Squibb, Princeton, NJ; ⁷Medical University of Vienna, Vienna, Wien, Austria

Introduction: Ozanimod (OZA) is approved for the treatment of moderately to severely active ulcerative colitis (UC). Induction and maintenance of mucosal healing (MH) is associated with improved long-term UC outcomes. Previous analyses have demonstrated that patients (pts) who achieved stringent MH at Week (W) 10 on OZA treatment demonstrated better outcomes at W52 than those with standard MH. This analysis of the phase 3 True North (TN) open-label extension (OLE) explored the impact of prior biologic exposure on the maintenance of long-term OZA efficacy in pts who achieved standard vs stringent MH at TN W52 before OLE entry.

Methods: The analysis evaluated TN pts who achieved MH using a standard definition (ie, mucosal endoscopy subscore [MES] ≤1 + histologic remission [HRem; Geboes score < 2.0]) at TN W52 while on continuous OZA treatment and entered the OLE. Of these pts, those who achieved stringent MH (MES=0 + HRem) at TN W52 were also assessed. Standard and stringent MH groups were categorized into subgroups based on prior biologic status (biologic-naive [bio-naive] or biologic-exposed [bio-exp]). Clinical (clinical response, clinical remission, corticosteroid-free remission, and endoscopic improvement) and mucosal (HRem, standard MH, and stringent MH) efficacy endpoints were evaluated at OLE W46 and W94.

Results: Of 230 pts who completed TN W52 while on continuous OZA, 26% (59/230) achieved standard MH at OLE entry (bio-naive: n=43; bio-exp: n=16). Of these 59 pts, 59% (n=35, of whom 31 were bio-naive) also achieved stringent MH. TN baseline demographics were generally similar across treatment groups except bio-exp pts had longer disease duration and more extensive UC than bio-naive pts. Overall, the percentages of pts with standard or stringent MH at TN W52 who achieved the evaluated clinical and mucosal endpoints were generally similar regardless of prior biologic use (Figure). Clinical endpoints were generally sustained through OLE W94 in both standard and stringent MH groups (Figure). The maintenance of mucosal endpoints over 94 wk in the OLE was similar regardless of prior biologic exposure (Figure).

Discussion: In TN, more bio-naive than bio-exp pts achieved standard or stringent MH after 52 wk of OZA treatment. Durability of clinical and mucosal efficacy of OZA was similar over 2 years during the OLE in pts with MH regardless of prior biologic exposure, indicating that attainment of mucosal efficacy is a predictor of clinical durability even in pts with prior biologic failure.

Figure: Figure. Clinical and mucosal efficacy of OZA at OLE W46 and W94 by prior biologic use in TN W52 OZA clinical responders with (A) standard MH or (B) stringent MH at OLE entry.

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.

Maia Kayal: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Fresenius – Consultant. GoodRx – Consultant. Pfizer – Consultant.

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.

Dimpy Mehra: 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.

Harris A. Ahmad: Bristol Myers Squibb – employee and/or shareholder.

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

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, Maia Kayal, MD², Ailsa Hart, BMBCh, PhD³, Charles Sninsky, MD⁴, Raymond K.. Cross, MD, MS, FACG⁵, Dimpy Mehra, PharmD⁶, Hsiuanlin Wu, MS⁶, Mark T. Osterman, MD, PhD⁶, Harris A. Ahmad, MD⁶, Anjali Jain, PhD⁶, Walter Reinisch, MD⁷. P0716 - Impact of Prior Biologic Exposure on the Long-Term Durability of Clinical and Mucosal Efficacy in Patients With Ulcerative Colitis Treated With Ozanimod, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.