Phoenix, AZ | October 27, 2025 – Johnson & Johnson’s TREMFYA® (guselkumab) becomes the first and only IL-23 inhibitor to demonstrate durable, two-year remission in Crohn’s disease using a fully subcutaneous treatment regimen, according to new long-term Phase 3 data presented at the 2025 American College of Gastroenterology (ACG) Annual Scientific Meeting. The results, derived from the GRAVITI and GALAXI study extensions, confirm TREMFYA’s sustained clinical and endoscopic efficacy at 96 weeks in adults with moderately to severely active Crohn’s disease (CD), further reinforcing its unique dual-acting IL-23 and CD64 mechanism.
Science Significance
Crohn’s disease, an inflammatory bowel disorder affecting millions worldwide, has long challenged sustained disease management due to fluctuating response and remission rates. TREMFYA® targets both IL-23 and CD64, two drivers of chronic intestinal inflammation, offering a dual mechanism not seen in other IL-23 inhibitors. At Week 96, clinical remission rates exceeded 85% for both maintenance regimens—100 mg every eight weeks (q8w) and 200 mg every four weeks (q4w). Endoscopic remission was achieved in over half of patients across both studies, and deep remission rates reached up to 51.2% in the GRAVITI trial and 49.0% in the pooled GALAXI cohort. “These findings provide compelling evidence of TREMFYA’s durable control of intestinal inflammation and mucosal healing over two years,” said Dr. David Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago. “Patients can now manage their condition with greater independence through a completely subcutaneous regimen.”
Regulatory Significance
TREMFYA® is now FDA-approved for both intravenous (IV) and subcutaneous (SC) induction in Crohn’s disease, alongside ulcerative colitis. Its approval was supported by robust data from the GALAXI 2, GALAXI 3, and GRAVITI Phase 3 programs, each employing a treat-through design assessing efficacy and safety through long-term extension periods up to five years. Johnson & Johnson’s recent findings mark the first presentation of two-year data confirming durable efficacy with SC-only administration, a critical step in regulatory differentiation within the IL-23 inhibitor class. The consistency of safety outcomes through 96 weeks further strengthens TREMFYA’s regulatory profile, showing no new safety signals compared with its established safety record in psoriasis and psoriatic arthritis indications.
Business Significance
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With the growing biologics market in inflammatory bowel disease (IBD) projected to surpass $30 billion globally by 2030, TREMFYA® positions Johnson & Johnson at the forefront of IL-23–targeted therapies. The new long-term data enhance its competitiveness against market rivals such as AbbVie’s Skyrizi® and Eli Lilly’s Omvoh™, particularly by offering both SC and IV induction flexibility. “As the only IL-23 inhibitor approved for both induction routes, TREMFYA® expands treatment personalization and convenience for patients,” noted Dr. Esi Lamousé-Smith, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “These results underscore our ongoing leadership in delivering therapies that drive deep, sustained remission.” Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, manufactured by Janssen Biotech, Inc. The company also confirmed its commitment to continued data generation through ongoing five-year long-term extension studies assessing real-world durability and safety.
Patients’ Significance
For patients living with Crohn’s disease, the implications of these findings are transformative. A fully subcutaneous regimen allows at-home administration, reducing dependence on infusion centers and enhancing long-term treatment adherence. Crohn’s disease affects an estimated three million Americans and four million Europeans, with symptoms including abdominal pain, diarrhea, and weight loss that severely impair quality of life. Current therapies often require infusion or lose efficacy over time, leaving gaps in sustained disease control. By achieving over 85% remission rates at two years, TREMFYA® provides a pathway to long-term stability for patients previously cycling through biologics without lasting benefit. The drug’s safety consistency through 96 weeks further reassures both patients and clinicians regarding prolonged therapy use
Policy Significance
The availability of durable, patient-friendly biologic therapies such as TREMFYA® could reshape reimbursement and care strategies in IBD management. With healthcare systems increasingly prioritizing outpatient and self-administered treatment models, fully subcutaneous biologics align with payer incentives to reduce hospital-based administration costs. Additionally, FDA’s continued support for novel IL-23 inhibitors demonstrates a broader regulatory shift toward precision immunology, emphasizing mechanistic differentiation and patient autonomy. The TREMFYA® pregnancy registry and long-term safety monitoring programs reflect ongoing efforts to integrate real-world evidence into therapeutic policy decisions.
Transaction Highlights
The 96-week data come from the long-term extensions of the Phase 3 GRAVITI, GALAXI 2, and GALAXI 3 trials, which evaluated both intravenous and subcutaneous induction followed by subcutaneous maintenance in adults with moderate to severe Crohn’s disease. Patients maintained high clinical remission rates—over 90% in GRAVITI and around 86% in the pooled GALAXI studies—at Week 96. Endoscopic response and remission were sustained in up to 73% and 57% of patients, respectively, while deep remission was achieved by nearly half. The safety profile remained consistent with prior studies, with no new safety signals observed. These findings, presented at the 2025 ACG Annual Scientific Meeting (Abstract #70), confirm TREMFYA®’s long-term efficacy and tolerability in a fully subcutaneous regimen.
Source: Johnson & Johnson Press Release
