Simponi (Janssen Biotech) shows positive results in Phase III trial for Ulcerative Colitis

A study of subcutaneous induction regimens of Simponi (golimumab), from Janssen Biotech/Merck Inc., induced clinical response in a majority of patients with moderately to severely active Ulcerative Colitis who had previously failed or were intolerant to conventional agents. The PURSUIT trial had an adaptive design with Phase II dose ranging followed by a confirmatory Phase III component. All enrolled patients had failed to respond to alternative treatments with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylate. Results show that 50 percent of patients in each of two dosing groups (high/low) achieved clinical response at week 6, the primary endpoint of the study, which was significantly more than those in clinical response after receiving placebo. Treatment with Simponi also resulted in significant induction of clinical remission and mucosal healing and improvement in health-related quality of life measures at week 6 compared with placebo, according to lead investigator, William Sandborn, professor of Gastroenterology at the University of California, San Diego School of Medicine. Results were presented at Digestive Disease Week in San Diego.