World Congress at ACG2017

Simultaneous Plenary Session 1B: IBD

14 - Safety and Efficacy of Long-term Treatment With Ozanimod: An Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis - TOUCHSTONE Extension 2-Year Follow-up

Monday, October 16
4:30 PM - 4:40 PM
Location: Valencia Ballroom BC (Level 4)



Category: IBD       

William J. Sandborn, MD1, Brian G. Feagan, MD, FACG2, Geert D'Haens, MD, PhD3, Stephen Hanauer, MD4, Douglas C. Wolf, MD5, Séverine Vermeire, MD, PhD6, Subrata Ghosh, MD7, Caiyan Li, PhD8, Darryl Penenberg, PhD8, AnnKatrin Petersen, MD8, Richard Aranda, MD8, Allan Olson, MD, MBA8
1University of California, La Jolla, CA; 2Robarts Research Institute, Western University, London, ON, Canada; 3Academic Medical Center, Amsterdam, Noord-Holland, Netherlands; 4Feinberg School of Medicine, Northwestern University, Evanston, IL; 5Atlanta Gastroenterology Associates, Atlanta, GA; 6University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium; 7University of Calgary, Calgary, AB, Canada; 8Receptos, a wholly owned subsidiary of Celgene, San Diego, CA
Introduction: Ozanimod, an oral, once-daily immunomodulator that selectively targets S1P1R and S1P5R, has demonstrated clinical efficacy in ulcerative colitis (UC) for induction and maintenance therapy in the TOUCHSTONE trial [1]. The objective of the open-label extension (OLE) of the TOUCHSTONE trial is to evaluate the long‑term efficacy and safety of daily 1 mg ozanimod in patients with moderate to severe UC who had initially participated in the TOUCHSTONE trial for up to 32 weeks.

Methods: A total of 197 patients were randomized (1:1:1) and treated with daily ozanimod 0.5 mg (n=65), 1 mg (n=67), or placebo (n=65) in the TOUCHSTONE trial. Of the initial 197, 170 (86%) entered the OLE and received daily ozanimod 1 mg. As of the data cut-off in March 2017, 100 (58.8%) had efficacy evaluations reported through Week 92; of these 100 patients, 94 (55.3%) had received ozanimod 1 mg/day in the OLE for ≥2 years. Efficacy data are reported as observed through Week 92 and safety includes all events through the data cut-off of March 2017.

Results: At OLE entry, the partial Mayo Score (pMS) for patients on placebo, ozanimod 0.5 mg, and 1.0 mg was 4.6, 4.5, and 3.3 respectively, which improved significantly by OLE Week 8 (–2.3, –1.9 and –1.1), with the greatest improvement reported in patients who had received placebo or ozanimod 0.5 mg in the TOUCHSTONE trial. At the OLE Week 92 visit, 91/100 (91.0%) had little or no active disease based on the physician global assessment (PGA 0 or 1), 97/100 (97.0%) had little or no blood in their stools (rectal bleeding subscore [RBS] 0 or 1), 86/100 (86.0%) had no blood in the stools (RBS 0).

Adverse events (AEs) and serious AEs were reported in 85 (50.0%) and 20 (11.1%) of patients respectively. The most common AEs (>2.0%) during OLE were UC flare, anaemia, nausea, upper respiratory tract infection, nasopharyngitis, back pain, arthralgia, headache, transaminase elevation, and hypertension. The only serious AEs in ≥2 patients were anaemia and UC flare. Transaminase level >3x upper limit of normal (ULN) occurred in 5 (2.9%) patients in the OLE. All elevations were asymptomatic, < 5xULN, transient, and resolving while receiving continued treatment.

Discussion: Long-term treatment with ozanimod continues to be safe and well tolerated with good compliance and evidence of durable efficacy.

Reference: [1] Sandborn WJ, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016;374(18):1754-62.

Supported by Industry Grant: Yes

Disclosures: Does Disclose

William Sandborn: Celgene – Consultant, Grant/Research Support.
Brian Feagan: Celgene – Consultant.
Geert D''Haens: AbbVie – Consultant, Speaker's Bureau. Ablynx – Consultant. AM Pharma – Consultant. Amakem – Consultant. Avaxia – Consultant. Biogen – Consultant, Speaker's Bureau. BMS – Consultant. Boerhinger Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Cosmo – Consultant. Covidien/Medtronics – Consultant. DrFALK Pharma – Consultant. Engene – Consultant, Stockholder/Ownership Interest (excluding diversified mutual funds). Ferring – Consultant, Speaker's Bureau. Galapagos – Consultant. Genentech/Roche – Consultant. Gilead – Consultant. GSK – Consultant. Hospira – Consultant. Immunic – Consultant. J&J – Consultant, Speaker's Bureau. Lycera – Consultant. Medimetrics – Consultant. Merck – Consultant, Speaker's Bureau. Millenium/Takeda – Consultant, Speaker's Bureau. Mitsubishi Pharma – Consultant. Mundipharma – Consultant, Speaker's Bureau. Norgine – Speaker's Bureau. NovoNordisk – Consultant. Otsuka – Consultant. Pfizer – Consultant, Speaker's Bureau. Prometheus Laboratories/Nestle – Consultant. Protagonist – Consultant. Robarts Clinical Trials – Consultant, Directorship. Salix – Consultant. Sandoz – Consultant. Setpoint – Consultant. Shire – Consultant, Speaker's Bureau. Teva – Consultant. Tigenix – Consultant. Tillotts – Consultant, Speaker's Bureau. Topivert – Consultant. Versant – Consultant. Vifor – Consultant, Speaker's Bureau.
Stephen Hanauer: Celgene – Consultant.
Douglas Wolf: Celgene – Consultant, Grant/Research Support.
Séverine Vermeire: Celgene – Consultant.
Subrata Ghosh: Celgene – Consultant.
Caiyan Li: Celgene – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Darryl Penenberg: Celgene – Stockholder/Ownership Interest (excluding diversified mutual funds).
AnnKatrin Petersen: Celgene – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Richard Aranda: Celgene – Advisory Committee/Board Member, Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Allan Olson: Celgene – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Citation: . SAFETY AND EFFICACY OF LONG-TERM TREATMENT WITH OZANIMOD: AN ORAL S1P RECEPTOR MODULATOR, IN MODERATE TO SEVERE ULCERATIVE COLITIS - TOUCHSTONE EXTENSION 2-YEAR FOLLOW-UP. Program No. 14. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

William J. Sandborn

Professor of Clinical Medicine
University of California - San Diego, San Diego, CA, United States
La Jolla, CA, US

Dr. William Sandborn completed medical school and an internal medicine residency at Loma Linda University in Loma Linda California. He completed a gastroenterology fellowship at the Mayo Clinic in Rochester Minnesota in 1993. From 1993-2010, he was on the faculty of the Mayo Clinic, rising to Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology, and Associate Dean of Research for Intellectual Property and Industry Relations. In 2011 he became Professor of Clinical Medicine at the University of California San Diego and Director of the IBD Center and Chief of the Division of Gastroenterology for the UC San Diego Health System. Dr. Sandborn has published over 405 peer reviewed articles including articles in the New England Journal of Medicine, the Lancet, JAMA, the Annals of Internal Medicine, and Gastroenterology. His research interests are clinical trials and clinical pharmacology related to inflammatory bowel disease.

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