Johnson & Johnson has announced new 3-year data from the Phase 3 GALAXI 2 and 3 studies evaluating TREMFYA® (guselkumab) in adults with moderately to severely active Crohn’s disease. The Week 144 long-term extension results were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. The findings show that TREMFYA® demonstrated sustained clinical and endoscopic remission through 3 years in moderately to severely active Crohn’s disease.
What Changed
In the Phase 3 GALAXI 2 and 3 clinical programs, adult patients with moderately to severely active Crohn’s disease received intravenous induction followed by subcutaneous maintenance regimens. Patients were administered either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w). Long-term extension data assessed at Week 144 demonstrated high rates of clinical and endoscopic remission across both maintenance regimens. Specifically, 94% of patients receiving TREMFYA 100 mg q8w and 91% receiving TREMFYA 200 mg q4w achieved clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150. Furthermore, 88% of patients in both the 100 mg q8w and 200 mg q4w arms achieved 90-day corticosteroid-free clinical remission.
Endoscopic Remission and Treatment Retention
Beyond symptom control, the study evaluated endoscopic outcomes. Endoscopic remission—defined as a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of four or less, alongside a two-point or greater reduction and no subscore greater than one on any subcomponent—was achieved by 52% of patients receiving TREMFYA 100 mg q8w and 61% of patients receiving TREMFYA 200 mg q4w. Additionally, 74% of TREMFYA-treated patients remained on treatment through the full three-year duration of the study.
Context and Disease Background
Crohn’s disease is a chronic, lifelong inflammatory condition that imposes a significant burden on patients. According to background details from the research, the condition affects an estimated three million Americans and approximately four million people across Europe. Managing a lifelong condition requires therapies that can maintain deep clinical and structural healing over extended periods. Company representatives emphasized the relevance of these findings for long-term disease management. In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients.
Technical and Business Explanation
TREMFYA is described as a dual-acting monoclonal antibody. Based on in vitro studies, it blocks Interleukin-23 (IL-23) while simultaneously binding to CD64 on cells that produce IL-23. Johnson & Johnson has built deep expertise in immune-mediated diseases, including inflammatory bowel disease. Company executives noted that the research is designed to answer clinical questions that emerge over the course of managing a chronic condition. The generation of long-term evidence aims to help physicians make informed treatment decisions for individuals living with Crohn’s disease.
Sector Impact and Business Implications
The release of 3-year Phase 3 data strengthens the clinical dossier for TREMFYA within the gastroenterology market. By demonstrating durable efficacy—including high rates of corticosteroid-free clinical remission and sustained endoscopic improvement—the therapy addresses key clinical goals in inflammatory bowel disease management. Sustained treatment retention rates of 74% through three years also provide visibility into real-world adherence and persistence profiles for the subcutaneous maintenance regimens.
Limitations and Uncertainties
While the clinical and endoscopic results outline long-term efficacy, certain limitations and uncertainties remain noted in the research data. The clinical significance of TREMFYA binding to CD64 in an inflammatory monocyte model is not known, because findings are limited to in vitro studies. Additionally, safety considerations note that it is not known if TREMFYA can harm an unborn baby or if it passes into breast milk. Overall safety findings through Week 144 were otherwise consistent with the well-established safety profile of TREMFYA in Crohn’s disease.
What to Watch Next
As Johnson & Johnson continues to present long-term findings from the GALAXI clinical program at major scientific meetings such as the American College of Gastroenterology, stakeholders will monitor how these 3-year outcomes influence clinical guidelines, physician adoption patterns, and broader market access strategies for inflammatory bowel disease therapeutics.