A single intravenous (IV) dose of Stelara (ustekinumab; Janssen) induced clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously had inadequate response or were intolerant to conventional or biologic therapies, according to new data from the Phase 3 UNIFI trial.
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, which randomized moderate-to-severe UC patients to a single IV dose of placebo, Stelara 130mg or Stelara ~6mg/kg (weight-tiered dosing). Patients were evaluated at week 8 for clinical remission, endoscopic healing, clinical response, change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score, and mucosal healing.
Results showed that at week 8, 15.6% of Stelara 130mg patients and 15.5% of Stelara ~6mg/kg patients achieved clinical remission vs 5.3% of placebo patients (P <.001). Also, 26.3% (130mg) and 27% (~6mg/kg) of Stelara patients experienced endoscopic healing vs 13.8% of placebo patients (P <.001).
Compared with 31.3% of placebo patients, 51.3% of Stelara 130mg and 61.8% of Stelara ~6mg/kg patients achieved clinical response (P <.001); clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1. In addition, a significantly greater proportion of patients in the Stelara group (20.3% and 18.4%, respectively) achieved mucosal healing vs placebo (8.9%; P <.001). Both Stelara doses led to statistically significant improvements in the IBDQ, as well as inflammation markers such as C-reactive protein, fecal lactoferrin, and calprotectin.
“Ulcerative colitis is a complex immune disease, and more than half of UC patients have not experienced remission with currently available conventional or biologic treatment options,” said lead investigator Bruce E. Sands, MD. “The significant rates of remission observed 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 UC.”
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