Spring House, Pennsylvania, United States, October 12, 2026
Johnson & Johnson has announced new three-year clinical data demonstrating sustained clinical and endoscopic remission with TREMFYA® (guselkumab) in adults with moderately to severely active Crohn’s disease. The findings come from the long-term extension of the Phase 3 GALAXI 2 and GALAXI 3 clinical trials and were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. The results, assessed at Week 144, highlight the potential of guselkumab to provide durable disease control and reduce reliance on corticosteroids in patients living with this chronic inflammatory bowel disease. The company also reported that the treatment’s safety findings remained consistent with its established safety profile in Crohn’s disease.
Three-Year Data Show Sustained Clinical Remission
The long-term extension results demonstrated high rates of clinical remission across both TREMFYA maintenance regimens. At Week 144, 94% of patients receiving 100 mg subcutaneously every eight weeks achieved clinical remission, compared with 91% of patients receiving 200 mg every four weeks. Clinical remission was defined using the Crohn’s Disease Activity Index (CDAI), with a score below 150 indicating remission. These findings provide important evidence regarding the durability of treatment response over an extended period. Maintaining symptom control is a significant treatment goal for people with Crohn’s disease, which can cause persistent gastrointestinal symptoms and substantially affect daily activities and quality of life. The reported outcomes suggest that patients who remained on treatment and had available Week 144 assessments could maintain clinical benefits over three years. However, the results represent an observed analysis of eligible long-term extension participants and should not be interpreted as remission rates for every patient who initially entered the trials.
Endoscopic Remission and Reduced Steroid Dependence
In addition to symptom improvement, the GALAXI 2 and GALAXI 3 findings highlighted sustained improvements in intestinal inflammation. Endoscopic remission reached 52% with the 100 mg every-eight-week regimen and 61% with the 200 mg every-four-week regimen at Week 144. Endoscopic assessment evaluates inflammation and visible disease activity in the intestinal lining, providing an important measure of treatment response beyond symptoms alone. The studies also reported that 88% of patients in each maintenance group achieved 90-day corticosteroid-free clinical remission. Reducing dependence on corticosteroids can be an important objective in long-term Crohn’s disease management, as prolonged use may be associated with significant adverse effects. Furthermore, 74% of TREMFYA-treated patients remained on treatment through three years, offering additional information about treatment continuation during the extension period. Together, these findings support continued investigation of guselkumab as a long-term therapeutic option for appropriately selected patients with moderately to severely active Crohn’s disease.
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Dual-Acting Mechanism Supports Treatment Development
TREMFYA is a fully human monoclonal antibody developed by Johnson & Johnson. Its mechanism involves blocking interleukin-23 (IL-23) and binding to CD64, a receptor expressed on certain immune cells involved in producing IL-23. IL-23 is a cytokine associated with inflammatory pathways implicated in immune-mediated diseases. The company describes TREMFYA as a dual-acting treatment designed to target inflammation through these mechanisms; however, evidence supporting aspects of its dual-acting mechanism includes in vitro findings, and the clinical significance of CD64 binding remains uncertain. The GALAXI program was designed to evaluate efficacy and safety in patients with moderately to severely active Crohn’s disease who had inadequate responses to or intolerance of conventional therapies and/or biologic treatments. The Phase 3 studies used a treat-through design and included long-term extensions intended to assess clinical outcomes, endoscopic response and safety over a total period of five years. The Week 144 results therefore provide an important interim view of longer-term treatment performance.
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract for which no cure is currently available. Symptoms may include abdominal pain, diarrhea, rectal bleeding and weight loss, while complications can further affect patients’ health and quality of life. Johnson & Johnson stated that the three-year findings reinforce its focus on generating long-term evidence to support treatment decisions in inflammatory bowel disease. Although the results are encouraging, ongoing follow-up will be important to characterize durability, safety and outcomes over the full planned extension period. Treatment decisions should continue to consider individual patient circumstances, clinical assessments and the medicine’s prescribing information.
Source: Johnson & Johnson press release
