The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142
Zeposia is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved to treat patients with ulcerative colitis
Bristol Myers Squibb (NYSE: BMY) today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC). Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142. No new safety signals emerged in the study. These data (Presentation #DOP44) will be presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022.
“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., Director, Gastroenterology and Endoscopy, IRCCS, San Raffaele Hospital and University Vita-Salute San Raffaele in Milan. “These findings demonstrate important and clinically meaningful responses across multiple key endpoints and build upon our current knowledge of the efficacy and safety profile of Zeposia.”
In the True North extension study, data from an interim analysis of patients (n=823) who had previously participated in the Phase 3 True North Zeposia clinical trial were examined.At Weeks 46, 94 and 142, 45% (203/452), 51% (109/213) and 45% (39/87) of participants, respectively, were in clinical remission, and 80% (352/441), 84% (176/209) and 86% (73/85) achieved clinical response, respectively. The efficacy of Zeposia in those who entered the long-term study as responders on Day 1 was higher compared to the total population, with 70% (107/152) and 69% (42/61) achieving clinical remission at Weeks 46 and 94, respectively, and 95% (145/152) and 98% (60/61) achieving clinical response at Weeks 46 and 94, respectively. At the time of this analysis, of the 823 patients from the Phase 3 True North trial who entered the open-label extension study, 64% subsequently completed Week 46, 34% completed Week 94, and 14% completed Week 142.The most common reason for discontinuation was lack of efficacy (21%). No new safety signals were seen with longer-term Zeposia use in the 1,158 patients within the pooled population, including patients from the Phase 2 Touchstone study and the Phase 3 True North study.
Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here.
“These data reinforce the growing body of evidence demonstrating the long-term efficacy and safety of Zeposia and showcase its role as an important therapeutic option before biologic and Janus kinase inhibitor treatments in patients with moderately to severely active ulcerative colitis,” said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “With our heritage in transformational science for immune-mediated diseases – and our commitment to inflammatory bowel disease research – we are seeking to find solutions that have the goal of redefining treatment outcomes and elevating standards of care for the gastroenterology community.”
About Ulcerative Colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an irregular, chronic immune response that creates inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school. Many patients have an inadequate response or do not respond at all to currently available therapies.It is estimated that approximately 12.6 million people worldwide are living with IBD.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis (UC) is unknown but may involve the reduction of lymphocyte migration into the intestines.
Bristol Myers Squibb is continuing to evaluate Zeposia in the ongoing True North open-label extension trial, designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active UC. The company is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.
The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020 and for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent in November 2021. The U.S. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020and adults with moderately to severely active UC on May 27, 2021.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.