Remo Panaccione, MD: GALAXI 2, GALAXI 3 Data for Guselkumab in Crohn’s Disease

Late-breaking phase 3 data presented at Digestive Disease Week (DDW) 2024 are highlighting guselkumab’s statistical superiority to placebo and ustekinumab among patients moderately to severely active Crohn’s disease based on identical, 48-week, randomized, double-blind, active-comparator GALAXI 2 and GALXI 3 registrational trials.¹

A fully human monoclonal antibody, guselkumab selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor to block the pathogenesis of inflammatory diseases. It is approved by the US Food and Drug Administration for the treatment of plaque psoriasis and psoriatic arthritis, with its original approval for plaque psoriasis dating back to 2017.²

“There is a host of key findings, so there's a lot to unpack here,” Remo Panaccione, MD, director of the inflammatory bowel disease unit at the University of Calgary, explained in an interview with HCPLive.

Data from both GALAXI 2 (n = 508) and GALAXI 3 (n = 513) demonstrated the superiority of both subcutaneous maintenance doses of guselkumab 200 mg every 4 weeks (Q4W) and 100 mg every 8 weeks (Q8W) over placebo with greater clinical response and remission. Of note, in GALAXI 2 and 3, both dose cohorts had statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints compared with ustekinumab.¹

The fully human IL-23 inhibitor’s safety profile remained consistent with the approved indications of moderate to severe plaque psoriasis and active psoriatic arthritis. At week 48, the number of patients with ≥1 adverse event, ≥1 serious adverse event, and an event leading to discontinuation were similar across the guselkumab, placebo, and ustekinumab treatment cohorts.¹

“I think because of the size and the nature of the trial design, we have two trials that independently established the short- and long-term efficacy of Tremfya over placebo. Now you also have this statistical superiority to ustekinumab across those very, very important endoscopic that we value so much in clinical practice,” Panaccione said.

References:

1. ^{Iapoce, C. GALAXI 2 & 3: Guselkumab Superior to Ustekinumab for Crohn's Disease. HCPLive. May 21, 2024. Accessed May 22, 2024. https://www.hcplive.com/view/galaxi-guselkumab-superior-ustekinumab-crohns-disease}
2. ^{Brooks, A. Guselkumab for the Treatment of Crohn Disease, with Remo Panaccione, MD. HCPLive. October 30, 2023. Accessed May 22, 2024. https://www.hcplive.com/view/guselkumab-for-the-treatment-of-crohn-disease-with-remo-panaccione-md}