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Sunday Poster Session

Category: IBD

P0734 - Long-Term Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis and Relapsing Multiple Sclerosis

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
Has Audio

    Presenting Author(s)

  • David Rubin, MD, FACG

    University of Chicago Medicine, Inflammatory Bowel Disease Center
    Chicago, IL

David T. Rubin, MD, FACG1, Bruce A.C. Cree, MD, PhD, MAS2, Douglas C. Wolf, MD, FACG3, Olga Alekseeva, MD4, Lorna Charles, PhD5, AnnKatrin Petersen, MD5, James K. Sheffield, MD, MBA, MSMD5, Chun-Yen Cheng, MS5, Jon V. Riolo, MD5, Diego Silva, MD5, Fred D. Lublin, MD6, Jeffrey A. Cohen, MD7, Silvio Danese, MD, PhD8
1University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; 2Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA; 3Center for Crohn’s Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta, GA; 4Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Nizhegorod, Russia; 5Bristol Myers Squibb, Princeton, NJ; 6Mount Sinai Medical Center, New York, NY; 7Mellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH; 8IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy

Introduction: Ozanimod (OZA), an oral sphingosine 1-phosphate (S1P) receptor modulator, is approved for the treatment (tx) of moderately to severely active ulcerative colitis (UC) and for the tx of relapsing multiple sclerosis (RMS). OZA is a first-in-class S1P receptor modulator approved for UC, and one of several S1P receptor modulators used for the tx of RMS. OZA has been extensively studied in RMS with large patient (pt) populations and long exposure times, which can provide more insight into the safety profile of OZA in UC.

Methods: This analysis evaluated the tolerability and safety of long-term OZA 0.92 mg/d tx from clinical trial data in adults with moderately to severely active UC and from clinical trial data in adults with RMS. The UC population included pts pooled from phase 2 (NCT01647516), phase 3 (NCT02435992), and respective open-label extension (OLE; NCT02531126) trials through January 10, 2022. The RMS population included pts treated with OZA 0.92 mg in DAYBREAK (NCT02576717; October 16, 2015–February 1, 2022), an ongoing OLE trial of pts from phase 1‒3 OZA studies. Safety outcomes included tx-emergent adverse events (TEAEs) and TEAEs of special interest based on association with S1P modulation. Exposure-adjusted incidence rates (EAIRs) per 100 pt-years (PY) were calculated to adjust for time on study.

Results: Mean (SD) OZA exposure in 1158 pts with UC was 28.4 (23.3) mo (2714.9 total PY exposure); OZA exposure in 2494 pts with RMS was 56.4 (15.9) mo (11,732.2 PY; UC and MS combined: 14,447.1 PY). TEAEs occurred in 74.6% of UC and 88.2% of RMS pts. Serious TEAEs were reported in 17.3% of UC and 14.1% of RMS pts, and TEAEs leading to OZA discontinuation in 9.3% and 3.6%, respectively. The most common TEAEs were lymphopenia (12.3%; EAIR 5.6/100 PY), anemia (8.4%; EAIR 3.7/100 PY), lymphocyte count decreased (7.9%; EAIR 3.5/100 PY), and nasopharyngitis (7.9%; EAIR 3.5/100 PY) in pts with UC, and nasopharyngitis (20.6%; EAIR 5.1/100 PY), headache (16.9%; EAIR 4.0/100 PY), and upper respiratory infection (11.9%; EAIR 2.7/100 PY) in pts with RMS. In UC and MS, respectively, EAIR/100 PY were 20.2 and 22.9 for any infection, 1.6 and 0.8 for serious infection, 1.2 and 1.4 for opportunistic infection, and 0.6 and 0.3 for malignancy. Alanine aminotransferase levels ≥5 times the upper limit of normal occurred in 2.3% and 0.8% of UC and RMS pts, respectively.

Discussion: Long-term OZA 0.92 mg/d was generally well tolerated and safe for most pts with moderately to severely active UC or RMS.


Disclosures:
David T. Rubin: AbbVie – Consultant. Alike Health – Stock Options. AltruBio – Consultant, Stock Options. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Cornerstones Health, Inc – Advisory Committee/Board Member. Crohn's & Colitis Foundation – Advisory Committee/Board Member. Datos Health – Stock Options. EcoR1 – Consultant. Eli Lilly – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Iterative Health – Stock Options. Janssen – Consultant. Kaleido Biosciences – Consultant. Pfizer – Consultant. Prometheus Biosciences – Consultant. Reistone – Consultant. Seres Therapeutics – Consultant. Syneos – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Trellus Health – Consultant.
Bruce A.C. Cree: Alexion – Consultant. Atara – Consultant. Autobahn Therapeutics – Consultant. Avotres – Consultant. Biogen – Consultant. EMD Serono – Consultant. Genentech – Grant/Research Support. Gossamer Bio – Consultant. Horizon Therapeutics – Consultant. Neuron23 – Consultant. Novartis – Consultant. Sanofi – Consultant. TG Therapeutics – Consultant. Therini Bio – Consultant.
Douglas C. Wolf: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. AstraZeneca – Grant/Research Support. Bristol Myers Squibb – Consultant, Grant/Research Support, Speakers Bureau. Eli Lilly – Consultant. Genentech – Grant/Research Support. Janssen – Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Consultant. Pfizer/Arena – Grant/Research Support. Takeda – Consultant, Grant/Research Support, Speakers Bureau.
Olga Alekseeva: Janssen – Speakers Bureau. Pfizer – Speakers Bureau. Takeda – Speakers Bureau.
Lorna Charles: Bristol Myers Squibb – employee and/or shareholder.
AnnKatrin Petersen: Bristol Myers Squibb – employee and/or shareholder.
James K. Sheffield: Bristol Myers Squibb – employee and/or shareholder.
Chun-Yen Cheng: Bristol Myers Squibb – employee and/or shareholder.
Jon V. Riolo: Bristol Myers Squibb – employee and/or shareholder.
Diego Silva: Bristol Myers Squibb – employee and/or shareholder.
Fred D. Lublin: Acorda – Advisory Committee/Board Member, Consultant. Actelion – Advisory Committee/Board Member, Consultant. Apitope – Advisory Committee/Board Member, Consultant. Atara – Advisory Committee/Board Member, Consultant. Biogen – Advisory Committee/Board Member, Consultant. BrainStorm Cell Therapeutics – Advisory Committee/Board Member, Consultant. EMD Serono – Advisory Committee/Board Member, Consultant. GW Pharmaceuticals – Advisory Committee/Board Member, Consultant. Immunic – Advisory Committee/Board Member, Consultant. Innate Immunotherapeutics – Advisory Committee/Board Member, Consultant. Jazz Pharmaceuticals – Advisory Committee/Board Member, Consultant. Mapi Pharma – Advisory Committee/Board Member, Consultant. MedDay – Advisory Committee/Board Member, Consultant. MedImmune/Viela Bio – Advisory Committee/Board Member, Consultant. Mylan – Advisory Committee/Board Member, Consultant. Novartis – Advisory Committee/Board Member, Consultant. Orion Biotechnology – Advisory Committee/Board Member, Consultant. Polpharma – Advisory Committee/Board Member, Consultant. Population Council – Advisory Committee/Board Member, Consultant. Receptos/Celgene – Advisory Committee/Board Member, Consultant. Roche/Genentech – Advisory Committee/Board Member, Consultant. Sanofi/Genzyme – Advisory Committee/Board Member, Consultant. Teva – Advisory Committee/Board Member, Consultant. TG Therapeutics – Advisory Committee/Board Member, Consultant.
Jeffrey A. Cohen: Biogen – Consultant. Bristol Myers Squibb – Consultant. Convelo – Consultant. Genentech – Consultant. H3 Communication – Speakers Bureau. Janssen – Consultant. Multiple Sclerosis Journal – serving as an editor. NervGen – Consultant. Novartis – Consultant. Pharmaceutical Security Institute – Consultant.
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.


David T. Rubin, MD, FACG1, Bruce A.C. Cree, MD, PhD, MAS2, Douglas C. Wolf, MD, FACG3, Olga Alekseeva, MD4, Lorna Charles, PhD5, AnnKatrin Petersen, MD5, James K. Sheffield, MD, MBA, MSMD5, Chun-Yen Cheng, MS5, Jon V. Riolo, MD5, Diego Silva, MD5, Fred D. Lublin, MD6, Jeffrey A. Cohen, MD7, Silvio Danese, MD, PhD8. P0734 - Long-Term Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis and Relapsing Multiple Sclerosis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.