Tremfya maintains clinical and endoscopic remission through three years in Crohn’s disease – Johnson & Johnson

Johnson & Johnson announced new three-year data from the Phase 3 GALAXI 2 and 3 studies showing durable efficacy and a consistent safety profile for TREMFYA (guselkumab) in adults with moderately to severely active Crohn’s disease.
The Week 144 long-term extension (LTE) results presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting reveal long-term clinical and endoscopic outcomes across both TREMFYA maintenance regimens in this chronic disease.

Clinical and endoscopic outcomes sustained through three years with TREMFYA
Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two TREMFYA maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w) or 200 mg administered subcutaneously every four weeks (q4w). At Week 144 the LTE data show:

i) 94% of patients receiving TREMFYA 100 mg q8w and 91% receiving TREMFYA 200 mg q4w achieved clinical remission.

ii) 8% of patients receiving TREMFYA 100 mg q8w and 88% receiving TREMFYA 200 mg q4w achieved 90-day corticosteroid-free clinical remission, respectively.

iii) 52% of patients receiving TREMFYA 100 mg q8w and 61% receiving TREMFYA 200 mg q4w achieved endoscopic remission.

iv) 74% of TREMFYA-treated patients remained on treatment through three years.

Safety findings through Week 144 were consistent with the well-established safety profile of TREMFYA in Crohn’s disease.

“In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients,” said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago. “These results contribute to the growing body of evidence that TREMFYA can provide patients with deep and sustained remission over time, creating a strong foundation for long-term disease management.”

Long-term disease control is an important need in Crohn’s disease management
As Crohn’s disease is a lifelong disease with no cure, patients and physicians need treatments that can provide sustained control of symptoms and intestinal inflammation over time. These results represent one of the most comprehensive three-year datasets in Crohn’s disease reported to date, demonstrating durable clinical, corticosteroid-free and endoscopic remission across both TREMFYA maintenance regimens.

“Johnson & Johnson has built deep expertise in immune-mediated diseases including inflammatory bowel disease, and our research is designed to answer questions that arise over the course of this chronic condition,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “The clinical and endoscopic remission observed with TREMFYA through three years reinforces our commitment to generating long-term evidence that can help physicians make informed treatment decisions for people living with Crohn’s disease.”

TREMFYA is the only approved dual-acting monoclonal antibody in inflammatory bowel disease (IBD) that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.

About the GALAXI program (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of TREMFYA in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). Each GALAXI study employed a treat-through design and includes a long-term extension period that will assess clinical, endoscopic, and safety outcomes with TREMFYA treatment through a total of five years. Patients received TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8 followed by TREMFYA 200 mg subcutaneous maintenance every 4 weeks; or TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8, followed by TREMFYA.