Tofacitinib-XELJANZ: Potential New Treatment Option For Moderate To Severe Ulcerative Colitis

MedicalResearch.com Interview with:

William J. Sandborn, MD

Professor of Medicine and Adjunct Professor of Surgery

Chief, Division of Gastroenterology

Vice Chair for Clinical Operations, Department of Medicine

Director, UCSD IBD Center

University of California San Diego and

UC San Diego Health System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis.

A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy.

The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term.

MedicalResearch.com: What should readers take away from your report?

Response: Treatment with oral tofacitinib is potentially a new treatment option for patients with moderate to severe ulcerative colitis, pending review by the FDA and other international regulatory bodies.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Future studies could include studies in children, studies to further evaluate the long term safety, etc.

Disclosures: I have received research grants from Pfizer, and have served as a consultant for Pfizer

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis

William J. Sandborn, M.D., Chinyu Su, M.D., Bruce E. Sands, M.D., Geert R. D’Haens, M.D., Séverine Vermeire, M.D., Ph.D., Stefan Schreiber, M.D., Silvio Danese, M.D., Brian G. Feagan, M.D., Walter Reinisch, M.D., Wojciech Niezychowski, M.D., Gary Friedman, M.D., Nervin Lawendy, Pharm.D., Dahong Yu, M.D., Ph.D., Deborah Woodworth, M.B.A., Arnab Mukherjee, Ph.D., Haiying Zhang, Ph.D., Paul Healey, M.D., and Julian Panés, M.D., for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators^*

N Engl J Med 2017; 376:1723-1736

May 4, 2017DOI: 10.1056/NEJMoa1606910