Medication Review: GALAXI & GRAVITI Clinical Trials & LTE Data

In this medication review video module, Kimberly Orleck, PA-C, reviews the long-term efficacy and safety of guselkumab in the treatment of Crohn’s disease, highlighting results from the Phase 3 GALAXI-2, GALAXI-3, and GRAVITI clinical trials and their long-term extension (LTE) data through week 96. The discussion examines outcomes following intravenous (IV) or subcutaneous (SC) induction therapy followed by SC maintenance dosing, demonstrating sustained clinical remission, endoscopic response, endoscopic remission, and deep remission across study populations. The module also reviews steroid-free outcomes and emphasizes the durability of response observed over two years of treatment, with high rates of patients maintaining remission. Safety data across the LTE studies showed a stable safety profile with no new safety signals and low rates of serious adverse events and infections, consistent with the known safety profile of guselkumab. This expert overview provides clinicians and advanced practice providers with important insights into long-term treatment outcomes and real-world implications for managing moderate-to-severe Crohn’s disease with IL-23 pathway inhibition.For more gastroenterology and hepatology educational content, visit the GHAPP Digital Hub and GHAPP ACE app.