The Janssen Pharmaceutical Companies of Johnson & Johnson have announced new data on STELARA ® (ustekinumab) for adults with moderate to severe ulcerative colitis (UC)
The data on STELARA shows treatment with a single intravenous (IV) dose of STELARA® (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response or intolerance to conventional or biologic therapies.
The findings will be presented as part of the Late Breaking Abstract Plenary at the American College of Gastroenterology (ACG) Annual Scientific Meeting 2018.
Results from the induction phase of the Phase 3 UNIFI study show that treatment with a single IV dose of ustekinumab, at both doses studied, induced clinical remission in a significantly greater proportion of UC patients at Week 8 (15.6% of patients receiving 130 mg ustekinumab and 15.5% of patients receiving ~6 mg/kg ustekinumab) compared with placebo.
Major secondary endpoints – including the proportion of patients in clinical response, endoscopic healing, as well as health-related quality of life scores – were significantly improved at week 8 among patients receiving ustekinumab compared with those receiving placebo. At least 50% of study participants were considered biologically refractory, and 17% had a history of inadequate response or intolerance to any anti-TNF antibody and vedolizumab.
Earlier this month Allergan launched two IBD clinical research programmes including EXPEDITION for ulcerative colitis. This year Sandoz received European Commission approval of Hyrimoz for use in all indications of the reference medicine, including rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Adverse events (AEs) were reported in similar proportions across ustekinumab and placebo treatment groups.
Lead investigator Dr Bruce E. Sands, MD, Dr Burrill B. Crohn research institute, Professor of Medicine and Chief of the Dr Henry D. Janowitz Division of Gastroenterology at Mount Sinai School of Medicine said, “Ulcerative colitis is a complex immune disease, and more than half of the patients with ulcerative colitis have not experienced remission with currently available conventional or biologic treatment options. The significant rates of remission observed in this refractory population through the 8-week induction, coupled with a safety profile that is well-documented through years of research and use in other immune diseases, demonstrate the potential for ustekinumab as an effective treatment for ulcerative colitis.”
Dr Philippe Szapary, MD, MSCE, Vice President, Clinical Development, Janssen Research & Development, LLC said, “Ustekinumab is the first and only biologic that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis. These induction data on STELARA from the Phase 3 UNIFI study underscore the potential for this unique pathway in the treatment of ulcerative colitis, which may lead to a new effective and safe treatment option for ulcerative colitis patients in the future.”