May 23, 2021: “Bristol Myers Squibb announced that additional data from multiple studies evaluating Zeposia (ozanimod) in ulcerative colitis (UC) were presented at Digestive Disease Week® (DDW), taking place virtually May 21-23, 2021.
These data deepen the understanding of Zeposia and reinforce Bristol Myers Squibb’s commitment to understanding and addressing unmet needs in gastroenterology.
Research being shared includes:
- Safety of Ozanimod in Patients with Moderately to Severely Active Ulcerative Colitis Over Time: Pooled Analysis from Phase 2, Phase 3, and Open-Label Extension Trials
- Pooled analysis including data from the Phase 2 TOUCHSTONE study, Phase 3 True North study and open-label extension trial. Long-term treatment with Zeposia showed a safety profile that was consistent with its known safety profile.
- These data (presentation 128) were featured as an oral presentation on May 21.
- Author: D’Haens
- Pooled analysis including data from the Phase 2 TOUCHSTONE study, Phase 3 True North study and open-label extension trial. Long-term treatment with Zeposia showed a safety profile that was consistent with its known safety profile.
- Rapid Induction Effects of Ozanimod on Clinical Symptoms and Inflammatory Biomarkers in Patients with Moderately to Severely Active Ulcerative Colitis: Results from the Induction Phase of True North
- Induction therapy with Zeposia improved symptoms of rectal bleeding and stool frequency in patients with moderately to severely active UC beginning as early as Week 2 and continuing through Week 10. Parallel reductions in inflammatory biomarkers were seen at Weeks 5 and 10 with Zeposia versus placebo.
- These data (presentation 460) were featured as an oral presentation on May 22.
- Author: Osterman
- Induction therapy with Zeposia improved symptoms of rectal bleeding and stool frequency in patients with moderately to severely active UC beginning as early as Week 2 and continuing through Week 10. Parallel reductions in inflammatory biomarkers were seen at Weeks 5 and 10 with Zeposia versus placebo.
- Corticosteroid-Free Remission in Patients with Moderately to Severely Active Ulcerative Colitis Treated with Ozanimod: Results from the Maintenance Phase of True North
- Maintenance treatment with Zeposia was associated with increased likelihood of achieving corticosteroid-free remission versus placebo at Week 52 across a wide range of patient characteristics in UC.
- These data (presentation 412) will be presented as a Grand Rounds: IBD presentation on May 23 from 11:35–11:40 a.m. EDT.
- Author: Schreiber
- Maintenance treatment with Zeposia was associated with increased likelihood of achieving corticosteroid-free remission versus placebo at Week 52 across a wide range of patient characteristics in UC.
“Together, these new data presented at Digestive Disease Week highlight the potential of Zeposia to address the need for additional safe and effective oral treatment options for adults with moderately to severely active ulcerative colitis,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb.
“We’ve made significant progress in our pursuit of more treatments with the potential to address the needs of patients living with gastrointestinal immune-mediated diseases and look forward to continuing our discussions with global regulatory health authorities to bring Zeposia to appropriate patients.”
