Janssen has announced new two-year data from the long-term extension of the Phase III UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis.
These data were presented as a late-breaking data presentation (LB01) at the 27th UEGW congress.
These data include 399 participants who were in clinical response eight weeks after receiving a single intravenous (IV) induction dose of ustekinumab and who were then randomised to receive ustekinumab subcutaneous (SC) 90mg injections every 12 weeks (q12w), ustekinumab SC 90mg injections every 8 weeks (q8w), or placebo, and who were treated in the long-term extension.
Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission. The percentage of patients receiving ustekinumab SC who were in symptomatic remission between weeks 44 and 92 ranged from 83 to 90%. Among patients who had achieved clinical remission at maintenance baseline, 69% of patients receiving ustekinumab q8w and 80% of patients receiving ustekinumab q12w maintained symptomatic remission at both weeks 44 and 92. Additional analyses demonstrated that approximately 60 percent of patients receiving ustekinumab q8w and q12w achieved corticosteroid-free symptomatic remission at week 92 (64.3% and 63.8%, respectively).
“Ulcerative colitis is a life-long and debilitating inflammatory bowel disease, interrupting the daily lives of millions of people around the world who may still be searching for an effective treatment option,” said lead study investigator Bruce E Sands, MD, Icahn School of Medicine, Mt. Sinai, New York, who will be delivering the oral presentation. “It’s encouraging to see data from long-term extension trials that can offer symptom relief and remission over time to those struggling with UC.”
“The Phase III UNIFI two-year data builds upon the growing body of evidence of ustekinumab as a promising treatment option for UC, further underscoring our commitment to advancing research and development in inflammatory bowel diseases,” said Jan Wehkamp, MD, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “We are proud to present these results for the first time at UEGW because we recognise the significant unmet needs that continue to persist in treating the life-altering symptoms of moderately to severely active UC.”