Phase III UNIFI study of Stelara positive for ulcerative colitis.- Janssen Biotech.

Janssen Biotech announced 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. 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 percent of study participants are considered biologic refractory, and 17 percent have a history of inadequate response or intolerance to an anti-TNF and/or Entyvio (vedolizumab).

At week 8, 15.6 percent of patients receiving Stelara 130 mg and 15.5 percent of patients receiving Stelara approx. 6 mg/kg achieved clinical remission compared with 5.3 percent of patients receiving placebo. Remission was defined as a Mayo score 2 or less points, with no individual subscore more than 1. In addition, 26.3 percent of patients receiving Stelara 130 mg and 27 percent of patients receiving Stelara approx. 6 mg/kg experienced endoscopic healing compared with 13.8 percent of patient receiving placebo. Endoscopic healing was defined as a Mayo endoscopy subscore of 0 (normal mucosa or inactive disease) or 1 (mild disease activity). Also at 8 weeks, 51.3 percent and 61.8 percent of patients receiving Stelara 130 mg and Stelara approx. 6 mg/kg achieved clinical response compared with 31.3 percent of patients receiving placebo. Clinical response was defined as a decrease from baseline in the Mayo score by at least 30% and at least 3 points, with either a decrease from baseline in the rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0 or 1.

Additionally, 20.3 percent and 18.4 percent of patients receiving Stelara 130 mg and Stelara approx. 6mg defined as combined endoscopic healing (Mayo endoscopy subscore of 0 or 1) and histologic healing (defined as 0-5% neutrophils in epithelium, no crypt destruction, and no erosions or ulcerations or granulations). In addition, both doses of Stelara resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD, as well as markers of inflammation, including C-reactive protein (CRP), fecal lactoferrin and calprotectin. Through week 8, adverse events (AEs), serious AEs and infections (including serious infections) were reported in similar proportions across Stelara and placebo treatment groups. The findings will be presented at the American College of Gastroenterology (ACG) Scientific Meeting 2018.

Comment: J&J anticipates filing a Biologics License Application for UC by the end of 2018 with the FDA and also applying in Canada, Europe and Japan in early 2019..