Johnson & Johnson has released new 48-week results from its Phase 3 ASTRO study, which evaluated the use of TREMFYA (guselkumab) as a subcutaneous induction and maintenance therapy for adults with moderately to severely active ulcerative colitis. The company reports that TREMFYA is now the first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes using a fully subcutaneous regimen over 48 weeks.
The data, presented at United European Gastroenterology (UEG) Week 2025, showed that patients receiving TREMFYA achieved higher rates of clinical remission, endoscopic improvement, endoscopic remission, and symptomatic remission compared to those given placebo. Specifically, at week 48, clinical remission was observed in up to 42.9% of patients on TREMFYA versus 7.2% for placebo; endoscopic improvement reached up to 47.1% versus 11.5%; endoscopic remission was seen in up to 26.4% versus 5%; and symptomatic remission occurred in up to 53.6% versus 14.4%.
TREMFYA acts as a dual-acting monoclonal antibody by blocking IL-23 and binding to CD64 on cells that produce IL-23—a cytokine associated with immune-mediated diseases such as ulcerative colitis.
The ASTRO study included both biologic/JAK inhibitor-naïve patients and those who were refractory to previous advanced therapies. Safety data were consistent with prior findings for TREMFYA.
“For many patients, having a subcutaneous induction option is an important step forward—offering the flexibility of at-home administration after proper training without compromising efficacy,” said Prof. Silvio Danese of IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele in Milan, Italy, who served as a study investigator. “These results show that a fully subcutaneous regimen of guselkumab can deliver meaningful clinical and endoscopic benefits that are sustained for a full year, supporting long-term disease control in ulcerative colitis.”
“These results reflect our unwavering commitment to advancing the science that delivers both meaningful outcomes and more choices for healthcare providers and their patients,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead at Johnson & Johnson Innovative Medicine. “TREMFYA is the only IL-23 inhibitor to offer a subcutaneous induction option in both Crohn’s disease and ulcerative colitis, the latter of which was recently approved by the U.S. FDA and supported by findings from the ASTRO study.This latest development offers patients and providers the choice of starting treatment for UC with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction.”
TREMFYA has been approved by regulatory agencies including the U.S. Food and Drug Administration (FDA) for use in adults with moderate-to-severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis via both intravenous (IV) or subcutaneous (SC) routes depending on indication.
Ulcerative colitis is described as a chronic condition affecting the large intestine where inflammation leads to symptoms such as frequent bowel movements or diarrhea mixed with blood or mucus.
More information about ongoing research can be found at https://www.jnj.com/innovativemedicine/immunology/gastroenterology.
TREMFYA is manufactured by Janssen Biotech Inc., part of Johnson & Johnson’s pharmaceutical segment which holds exclusive global marketing rights.
Patients considering TREMFYA should be aware it may cause serious side effects including allergic reactions or increased risk of infections due to immune system suppression; liver function monitoring may also be necessary during treatment for inflammatory bowel diseases like Crohn’s or ulcerative colitis.
For additional prescribing details or reporting adverse events visit www.tremfya.com or www.fda.gov/medwatch.