Journal Club: Guselkumab Efficacy & Safety in Moderate to Severe CD-GALAXI 2 & 3 Results

In this video, Jamie Brogan, NP, from Northwestern Medicine in Chicago, discusses the efficacy and safety of Guselkumab therapy for patients with moderate to severely active Crohn’s disease, highlighting results from the Galaxy 2 and Galaxy 3 trials. Guselkumab is a dual-acting IL-23p19 subunit inhibitor, designed to neutralize IL-23 and bind to the CD64 receptor, which plays a role in the production of IL-23.

The Galaxy 2 and 3 Phase 3 trials used a randomized, double-blind, double-dummy treat-through design to evaluate IV induction and subcutaneous maintenance therapy in Crohn’s patients. The co-primary endpoints included clinical response at Week 12 and clinical remission at Week 48, along with clinical response at Week 12 and endoscopic response at Week 48. Achieving endoscopic response is particularly significant, as it has been shown to reduce disease progression, flares, hospitalizations, and the need for surgery.

The study results showed strong efficacy for Guselkumab therapy. In Galaxy 2, 49% to nearly 55% of Guselkumab patients achieved clinical response at Week 12 and remission at Week 48, compared to 11.8% on placebo. In Galaxy 3, 46.9% and 48% of Guselkumab patients met the same criteria, compared to 12.2% on placebo. Additionally, Guselkumab met all secondary endpoints and demonstrated superiority to ustekinumab at Week 48 for endoscopic response, endoscopic remission, and deep remission.

The safety profile of Guselkumab therapy remained consistent and favorable. The most common adverse events reported were COVID-19, upper respiratory infections, Crohn’s disease worsening, arthralgia, and headache, with no deaths observed.

These results underscore Guselkumab’s potential as an effective maintenance therapy for Crohn’s disease. Watch this video for an in-depth analysis, and visit the GHAPP website or download the GHAPP ACE app for more details.