Guselkumab Demonstrates Long-Term Benefit for Crohn Disease

Anita Afzali, MD, MPH, MHCM

Credit: UC Health

Johnson & Johnson Innovative Medicines has announced new data from the long-term extension of the GALAXI phase 2 study for guselkumab (Tremfya) in patients with moderate to severe Crohn disease (CD).

Announced on October 16, 2023, the new data, presented at United European Gastroenterology Week 2023, showed rates of clinical remission and endoscopic response among participants treated with guselkumab in the phase 2 GALAXI 1 trial were maintained through 3 years in a long-term extension study.¹

“The results from the GALAXI long-term extension strengthen our confidence in TREMFYA’s potential for patients with moderate-to-severe Crohn’s disease,” said Anita Afzali, MD, MPH, MHCM, executive vice chair of internal medicine and associate chief medical officer at the University of Cincinnati College of Medicine.¹ “These insights are especially helpful to physicians, as research continues investigating the efficacy and safety profile of TREMFYA for its use as a potential treatment option for their patients in need of lasting relief.”

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. The agent boasts previous approvals from the FDA for the treatment of plaque psoriasis and psoriatic arthritis, with its original approval for plaque psoriasis dating back to 2017.¹

A randomized, double-blind, placebo- and active-controlled, phase 2 study, GALAXI 1 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 tirals. To be included in the GALAXI program, participants were required to have moderately to severely active CD with inadequate response or intolerance to conventional therapies and/or biologics. In total, 1409 participants were enrolled and randomly assigned 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.^2,3

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.^2,3

According to the release, 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

“Establishing the long-term efficacy and safety profile of TREMFYA is an important step as we work to bring relief and remission to the millions of people worldwide living with Crohn’s disease,” said Jan Wehkamp, MD, PhD, vice president and gastroenterology disease area leader at Johnson & Johnson Innovative Medicines.¹ “We remain committed to researching and developing novel therapies, and to deepening our understanding of the interleukin (IL)-23 pathway with the goal of offering patients a range of treatment options that best fit their needs.”

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.
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 13, 2023. https://clinicaltrials.gov/study/NCT03466411
3. Johnson & Johnson. The Majority of Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study Achieved Clinical Remission and Corticosteroid-Free Remission Through 48 Weeks with TREMFYA® (guselkumab). February 18, 2022. Accessed October 13, 2023. https://www.janssen.com/majority-adults-moderately-severely-active-crohns-disease-phase-2-study-achieved-clinical-remission