Strong new data for Stelara in severe ulcerative colitis presented at ACG

New data showing 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 were intolerant to conventional or biologic therapies are being presented today at the American College of Gastroenterology (ACG) Scientific Meeting 2018.

Currently approved in the US for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease, Stelara is already a blockbuster drug for US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen units, and generated second-quarter sales of $1.3 billion.

Results from the induction phase of the Phase III UNIFI study show that treatment with a single IV dose of Stelara induced clinical remission in a significantly greater proportion of UC patients at week 8, compared with placebo, at both doses studied. Major secondary endpoints including the proportion of patients in clinical response, endoscopic healing, as well as improvement in health-related quality of life, were also significantly higher at week 8 among patients receiving Stelara compared with patients receiving placebo. About 50% of study participants are considered biologic refractory, and 17% have a history of inadequate response or intolerance to an anti-TNF and/or Entyvio (vedolizumab).