Pharmaceutical industry company Johnson & Johnson (NYSE:JNJ) on Monday reported positive results from the Phase 3 GRAVITI study of TREMFYA (guselkumab), the first and only IL-23 inhibitor, for treating adults with moderately to severely active Crohn's disease.
Significant clinical remission and endoscopic responses were observed at 48 weeks. Data presented at the American College of Gastroenterology (ACG) 2024 highlighted that over half of patients receiving TREMFYA achieved clinical remission by Week 12, compared to 21.4% in the placebo group.
At Week 48, clinical remission rates were 60.0% and 66.1% for TREMFYA maintenance doses of 100mg every eight weeks and 200mg every four weeks, respectively, versus 17.1% for placebo. Endoscopic responses were similarly improved, with 44.3% and 51.3% achieving endoscopic response in the respective treatment groups.
TREMFYA's safety profile remains well established, with recent FDA approvals for ulcerative colitis and ongoing reviews for Crohn's disease treatment. Regulatory applications for TREMFYA have also been submitted in Europe. The GRAVITI study emphasizes the drug's efficacy for patients who have not responded to conventional therapies.
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