Phase 3 Study Results Show Anti-TNF SIMPONI® Induced Clinical Response in Adults With Moderately to Severely Active Ulcerative Colitis
First Presentation of Phase 3 Data Shows Significant Improvements in Clinical Remission, Mucosal Healing and Quality of Life Measures after SIMPONI Induction Treatment
New study findings show that subcutaneous induction regimens of the anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI (golimumab) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis (UC) who had previously failed or were intolerant to conventional agents.
Investigators presented data from the Janssen Research & Development-sponsored Phase 3 study at Digestive Disease Week during a late breaker session and reported that more than 50 percent of patients in each of two SIMPONI dosing groups achieved clinical response at week six, 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 six compared with placebo.