Treatment with STELARA induced clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy, according to new data presented at the American College of Gastroenterology's annual meeting.
Here are five notes:
1. The phase 3 UNITI-2 study, sponsored by Janssen Research & Development, focused on examining the efficacy and safety of STELARA, is a monoclonal antibody that targets interleukin-12 and IL-23 cytokines.
2. Patients participating in the study received a single intravenous infusion of placebo, STELARA 130 mg or STELARA ~6 mg/kg.
3. At week six, 52 percent of patients receiving STELARA 130 mg and 56 percent of patients receiving STELARA ~6 mg/kg achieved clinical response.
4. At week eight, 47 percent and 58 percent of patients receiving STELARA 130 mg and STELARA ~6 mg/kg respectively achieved clinical response, compared with 32 percent of patients receiving placebo.
5. STELARA also resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire, a health-related quality of life measure for IBD patients.