New TREMFYA® (guselkumab) study shows consistent perianal fistula remission across key Crohn's disease patient subgroups
Key Highlights
- ➤TREMFYA 100 mg q8w achieved 28% combined fistula remission at Week 24
- ➤TREMFYA 200 mg q4w achieved 27% combined fistula remission versus placebo's 10%
- ➤Subgroup analyses showed consistent remission outcomes among patients with prior biologic exposure
- ➤FUZION is the first dedicated Phase 3 trial in over 20 years
Expert Statements
Bruce Sands, MD, MS; Dr. Burrill B. Crohn Professor of Medicine, Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology, Mount Sinai Health System
“Perianal fistula remain one of the most debilitating manifestations of moderate to severe Crohn's disease and many patients continue to experience persistent drainage, pain and complications,”
Bruce Sands, MD, MS; Dr. Burrill B. Crohn Professor of Medicine, Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology, Mount Sinai Health System
“These subgroup analyses show that the outcomes observed with TREMFYA were consistent across clinically important patient populations, further strengthening the evidence supporting its use in this difficult to treat patient population.”
David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson
“Johnson & Johnson has a longstanding commitment to advancing the science of inflammatory bowel disease, including for patients living with some of its most complex manifestations,”
David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson
“FUZION was designed to generate rigorous evidence specifically in Crohn's disease with perianal fistula, helping us deepen our understanding of how TREMFYA can address an area of unmet need.”
New TREMFYA® (guselkumab) study shows consistent perianal fistula remission across key Crohn's disease patient subgroups PR Newswire
* New prespecified analyses showed consistent findings across clinically important and difficult to treat subgroups, including patients with prior biologic exposure * Findings build on first positive results where TREMFYA achieved combined fistula remission rates of up to 28% across dosing groups * Results come from the first dedicated Phase 3 randomized, placebo-controlled trial in adults managing Crohn's disease with perianal fistula in more than 20 years SPRING HOUSE, Pa., Oct. 12, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new Phase 3 data showing consistent combined fistula remission outcomes with TREMFYA(®) (guselkumab) across clinically important subgroups of adults with Crohn's disease with perianal fistula.(1) The prespecified subgroup analyses from the FUZION study are being presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting and build on previously reported Week 24 results from the overall study population.
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