New Phase III trial data presented at the American College of Gastroenterology (ACG) 2024 conference reveals that guselkumab, a biologic developed by Johnson & Johnson, shows promise as a subcutaneous induction and maintenance therapy for Crohn's disease. The GRAVITI trial (NCT05197049) demonstrated significant clinical remission and endoscopic response at 48 weeks in adults with moderate to severe active Crohn's disease.
The study found that over 50% of patients treated with subcutaneous guselkumab at Weeks 0, 4, and 8 achieved clinical remission by Week 12, compared to 21.4% in the placebo group. Furthermore, improvements in clinical remission were observed as early as Week 4 in the guselkumab group. At Week 48, clinical remission rates were over three times greater with both maintenance doses of guselkumab compared to placebo.
Guselkumab, marketed as TREMFYA®, is a monoclonal antibody that neutralizes inflammation by blocking IL-23 and binding to CD64. These findings suggest that subcutaneous induction with guselkumab is a promising approach for managing Crohn's disease symptoms and achieving meaningful endoscopic improvements.
Rapid Onset of Action
According to Dr. Remo Panaccione, FRCPC, Study Investigator and Professor of Medicine at the University of Calgary, the induction treatment with subcutaneous guselkumab is as rapid and robust as intravenous induction, offering a potential new option for Crohn's disease treatment.
Potential for Dual Administration Options
Dr. Esi Lamousé-Smith, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine, noted that TREMFYA has the potential to become the only IL-23 inhibitor to offer both subcutaneous and intravenous induction options for Crohn's disease, providing choice and flexibility for patients. If approved, this could represent a significant advancement in the treatment landscape for Crohn's disease.
