The long-term extensions of Johnson & Johnson‘s Phase 3 GALAXI 2, GALAXI 3, and GRAVITI studies yielded compelling new two-year data today. The findings show that adults with moderately to severely active Crohn’s disease (CD) maintain high rates of durable remission when treated with TREMFYA® (guselkumab), the first and only approved IL-23 inhibitor with a fully subcutaneous (SC) treatment regimen.
The long-term safety and effectiveness of TREMFYA® are further supported by the 96-week data, which were presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG).
At week 96, patients receiving SC maintenance doses of TREMFYA® demonstrated robust, long-lasting outcomes in the pooled GALAXI 2 and 3 trials.
- 86.7% of patients on 100 mg every eight weeks (q8w) and 87.1% of patients on 200 mg every four weeks (q4w) were in clinical remission, which is indicated by a CDAI score of less than 150.
- Additionally, endoscopic remission was attained by 56.6% (200 mg q4w) and 56.3% (100 mg q8w).
- 51.2% (100 mg q8w) and 49.0% (200 mg q4w) of patients experienced deep remission (both clinical and endoscopic remission).
High efficacy rates were also observed at 96 weeks in the GRAVITI study, which assessed a fully subcutaneous induction and maintenance regimen.
- Clinical remission was reached by 92.0% of patients on 100 mg q8w and 93.4% of patients on 200 mg q4w.
- Endoscopic remission was attained by 46.0% (200 mg q4w) and 41.5% (100 mg q8w).
As the only IL-23 inhibitor approved for both subcutaneous SC and IV induction in Crohn’s disease and now also in ulcerative colitis, TREMFYA provides patients and their providers with meaningful choices in how they begin treatment with proven long-term benefits,
These results underscore our legacy of delivering innovations that address the diverse needs of people living with IBD, while continuing to provide treatment options that deliver deep and sustained remission over time.
Esi Lamousé-Smith
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A First-in-Class Treatment
The first and only authorised dual-acting monoclonal antibody that binds to CD64, a receptor on IL-23-producing cells, and blocks the cytokine IL-23 is called TREMFYA®. One of the main causes of immune-mediated illnesses like Crohn’s disease is targeted by this mechanism.
The new information comes after the U.S. Food and Drug Administration (FDA) recently approved TREMFYA for use in treating adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis. The FDA approved both subcutaneous and intravenous (IV) induction options. Because of this, TREMFYA® is the only IL-23 inhibitor that gives patients and healthcare professionals options regarding how to start treatment.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
