Janssen has announced new two-year data from the long-term extension of the Phase III UNIFI study, demonstrating the efficacy and safety of Stelara (ustekinumab) in moderately to severe ulcerative colitis (UC).
The data, presented at the United European Gastroenterology Week (UEGW) congress, show the findings from two years of evaluated treatment in adults with the disease.
399 participants who were in clinical response eight weeks after receiving a single intravenous (IV) induction dose of the drug and who were then randomised to receive subcutaneous (SC) 90 mg injections every 12 weeks (q12w), SC 90 mg injections every eight weeks (q8w), or placebo, and who were treated in the long-term extension.
The data showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission, and the percentage of patients receiving subcutaneous Stelara who were in symptomatic remission between weeks 44 and 92 ranged from 83 to 90%.
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, Icahn School of Medicine, Mt. Sinai, New York, who will be delivering the oral presentation.
He continued, “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 two-year data builds on the growing body of evidence of the treatment as a promising treatment option for ulcerative colitis, having already been approved for the indication in the European Union (EU) and the United States.
UC – a chronic disease of the large intestine, also known as the colon – affects up to 2.6 million people in Europe. It is the result of an abnormal response by the body’s immune system, and symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhoea, abdominal pain, bloody stools, loss of appetite, weight loss and fatigue.
