Guselkumab for the Treatment of Crohn Disease, with Remo Panaccione, MD

Results from the long-term extension of the GALAXI phase 2 study for guselkumab (Tremfya) in patients with moderate to severe Crohn disease (CD) showed rates of clinical remission and endoscopic response among participants treated with guselkumab were maintained through 3 years.

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 2017.¹

The randomized, double-blind, placebo- and active-controlled, phase 2 GALAXI 1 study assessed the safety and efficacy of guselkumab dose regimens to support the selection of induction and maintenance dose regimens for confirmatory evaluation in phase 3 GALAXI 2 and GALAXI 3 trials. For inclusion in the study, participants were required to have moderately to severely active CD with inadequate response or intolerance to conventional therapies and/or biologics.²

In total, 1409 participants underwent randomization to treatment with guselkumab dosed at 200, 600 or 1200 mg IV at weeks 0, 4, and 8, respectively, treatment with ustekinumab dosed at 6 mg/kg IV at week 0 and then dosed at 90 mg SC at week 8, or IV placebo. Upon completion of the 48-week GALAXI 1 trial, select participants were enrolled in the GALAXI 1 long-term extension study and continued with their previously assigned maintenance regimen to assess clinical, endoscopic, and safety outcomes through 5 years.¹

Announced by Johnson & Johnson Innovative Medicines on October 16, 2023, and presented at United European Gastroenterology Week 2023, long-term trial results showed 54.1% of participants assigned to guselkumab 100 mg every 8 weeks and guselkumab 200 mg every 4 weeks achieved clinical remission, while 51.4% achieved patient-reported outcome (PRO)-2 remission and 34.7% achieved endoscopic response. Among patients assigned to ustekinumab, 46.0% achieved clinical remission, 39.7% achieved PRO-2 remission, and 19.4% achieved endoscopic response.¹

The editorial team of HCPLive Gastroenterology sat down Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, for more insight into study results and the use of guselkumab for the treatment of CD.

References:

1. Johnson & Johnson. TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn's Disease in a Phase 2 Study. October 16, 2023. https://www.prnewswire.com/news-releases/tremfya-guselkumab-maintains-key-efficacy-endpoints-through-three-years-for-adults-with-moderately-to-severely-active-crohns-disease-in-a-phase-2-study-301956858.html
2. Clinicaltrials.gov. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI). October 11, 2023. Accessed October 26, 2023. https://clinicaltrials.gov/study/NCT03466411
3. Brooks, A. Guselkumab Demonstrates Long-Term Benefit for Crohn Disease. HCPLive. October 16, 2023. Accessed October 26, 2023. https://www.hcplive.com/view/guselkumab-demonstrates-long-term-benefit-for-crohn-disease