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, according to new data from the Phase 3 UNIFI trial announced by Janssen Pharmaceutical Companies of Johnson & Johnson.
“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,” said lead investigator Dr. Bruce E. Sands.
Study authors at the American College of Gastroenterology (ACG) Scientific Meeting 2018 presented late-breaking data from the induction phase of the Phase 3 UNIFI study. The results showed 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.
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.
At Week 8:
- 6% of patients receiving 130 mg ustekinumab and 15.5% of patients receiving ~6 mg/kg ustekinumab achieved clinical remission, compared with 5.3% of patients receiving placebo.
- 3% of patients receiving 130 mg ustekinumab and 27.0% of patients receiving ~6 mg/kg ustekinumab experienced endoscopic healing, compared with 13.8% of patients receiving placebo.
- 3% of patients receiving 130 mg ustekinumab and 61.8% of patients receiving ~6 mg/kg ustekinumab achieved a clinical response, compared with 31.3% of patients receiving placebo.
- Patients receiving 130 mg and ~6 mg/kg ustekinumab achieved statistically significant improvements from baseline IBDQ (31.5 and 31.0 respectively) compared with placebo (10.0).
- 3% of patients receiving 130 mg ustekinumab and 18.4% of patients receiving ~6 mg/kg ustekinumab achieved mucosal healing compared with 8.9% of patients receiving placebo.
“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 uses in other immune diseases, demonstrates the potential for ustekinumab as an effective treatment for ulcerative colitis,” said Sands.