Efficacy & Safety of Subcutaneous Guselkumab: 48-Week Results from the Phase 3 GRAVITI Study

The GRAVITI study provides compelling Phase 3 data on guselkumab, an IL-23 p19 subunit inhibitor, demonstrating its efficacy and safety in patients with moderate to severely active Crohn’s disease. In this Journal Club video module, Alison Moe, PA-C, from Atlanta Gastroenterology, breaks down the key findings, discussing clinical remission rates, endoscopic outcomes, and patient safety data at week 12, week 24, and week 48. The study highlights guselkumab’s dual mechanism of action, blocking IL-23 and binding to CD64, with both IV induction and subcutaneous maintenance proving effective in both biologic-naïve patients and those with prior biologic failure. The data shows significant improvements in clinical and endoscopic remission rates, with no major serious adverse events beyond mild upper respiratory infections. The findings reinforce guselkumab’s role as a treatment option for patients needing a targeted IL-23 therapy with flexible dosing options.

For more details on the GRAVITI study and the latest updates in IBD management, visit the GHAPP website or download the GHAPP ACE app.