· 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. (October 12, 2026) – Johnson & Johnson 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.[i] 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.
In the overall study population, 28% of patients receiving TREMFYA 100 mg q8w and 27% receiving TREMFYA 200 mg q4w achieved the composite endpoint of combined fistula remissiona at Week 24, compared with 10% receiving placebo, making TREMFYA the only IL-23 inhibitor to demonstrate efficacy in a dedicated, randomized, placebo-controlled trial in patients with Crohn’s disease with perianal fistula.1
New subgroup analyses show consistent outcomes across key patient subgroups
Expanding on previously reported results in the overall population, new prespecified subgroup analyses showed greater Week 24 combined fistula remission with TREMFYA versus placebo among:1
-
Patients with greater luminal disease activity at baseline (CDAI ≥220): 30% and 21% with TREMFYA 100 mg SC q8w and 200 mg SC q4w, respectively, versus 0% with placebo
-
Patients with prior biologic exposure: 21% and 29%, respectively, versus 5% with placebo
-
Patients with proctitis at baseline: 26% and 27%, respectively, versus 12% with placebo
-
Patients without proctitis at baseline: 29% and 27%, respectively, versus 10% with placebo
Adverse events were consistent with the known safety profile of TREMFYA in Crohn’s disease.1
“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,” said Bruce Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology at 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.”
Addressing an important need in Crohn’s disease
Perianal fistula affects nearly 25% of patients with Crohn’s disease and is a severe, often debilitating manifestation associated with pain, persistent drainage, recurrent abscesses and a frequent need for surgical intervention.[ii] [iii] FUZION is a dedicated randomized, placebo-controlled Phase 3 study designed to evaluate TREMFYA in adults with Crohn’s disease with perianal fistula.
“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,” said 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.”
TREMFYA is the only approved dual-acting monoclonal antibody in inflammatory bowel disease (IBD) that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.45678
Dr. Bruce Sands is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
Editor’s notes:
a. Combined fistula remission was defined as complete closure of all external fistula openings with no drainage, without development of new fistulas, and absence of underlying fluid collections on MRI.
About the FUZION study (NCT05347095)
FUZION is a randomized, placebo-controlled, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of TREMFYA in adults with Crohn’s disease with perianal fistula.Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, CD Activity Index [CDAI] <350, and inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or up to 2 advanced therapy classes. Patients were randomized 2:2:1 to receive TREMFYA 200 mg intravenous (IV) induction at Weeks 0, 4, 8 weeks followed by TREMFYA 100 mg subcutaneous (SC) induction every 8 weeks (q8w); or TREMFYA 200 mg IV infusion in at Weeks 0, 4, 8 weeks followed by TREMFYA 200 mg SC every 4 weeks (q4w); or placebo.9
About Crohn’s disease
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe. 10 11 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.[xii] Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.Some patients may also develop fistulas, abnormal connections between the intestine and other organs or tissues, which can be associated with pain, drainage, infection, and substantial impairment in quality of life. Currently no cure is available for Crohn’s disease.[xiii]
About TREMFYA (guselkumab)
Developed by Johnson & Johnson, TREMFYA is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism are limited to in vitro studies that demonstrate TREMFYA binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.
TREMFYA is a prescription medicine approved in the U.S. to treat:
-
adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
-
adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.
-
adults with moderately to severely active ulcerative colitis.
-
adults with moderately to severely active Crohn’s disease.
TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn’s disease and adults with moderate-to-severe ulcerative colitis.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
REFERENCES
1 Bruce E. Sands, Alisa Hart, et al Efficacy of Guselkumab in Perianal Fistulizing Crohn’s Disease: Week 24 Results From The Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter FUZION Study. P5691 at ACG Annual Scientific Meeting 2026. October 13 2026
2 Sulak A., et al. Where Are We and Where to Next?—The Future of Perianal Crohn’s Disease Management, Journal of Clinical Medicine, Volume 12, Issue 19, October 2023, 6379, https://doi.org/10.3390/jcm12196379.
3 Spinelli A, Yanai H, Girardi P, Milicevic S, Carvello M, Maroli A, Avedano L. The Impact of Crohn’s Perianal Fistula on Quality of Life: Results of an International Patient Survey. Crohns Colitis 360. 2023 Jul 25;5(3):otad036. doi: 10.1093/crocol/otad036. PMID: 37529012; PMCID: PMC10390083.
4 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn’s and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
5 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
6 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
7 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
8 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
9 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn’s Disease (FUZION CD). Identifier: NCT05347095. https://clinicaltrials.gov/study/NCT05347095?tab=researcher. Accessed March 2026.
10 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed August 2026.
11 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
12 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed August 2026.
13 Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed August 2026.