Johnson & Johnson has announced results from its phase 3 FUZION study evaluating TREMFYA (guselkumab) in adults with active perianal fistulizing Crohn’s disease (CD).
At Week 24, TREMFYA demonstrated significantly higher rates of combined fistula remission, a stringent endpoint defined as complete external closure of draining fistulas and absence of fluid collection on MRI, compared to placebo. Remission in patients with this complicated manifestation remains difficult to achieve, and this is the first randomised control trial of an approved therapy in inflammatory bowel disease (IBD) that demonstrates efficacy in adults with active perianal fistulizing Crohn’s disease in 20 years. These late-breaking data are among the 32 company-sponsored abstracts at Digestive Disease Week (DDW) 2026.
TREMFYA met the primary endpoint of combined fistula remission at Week 24, defined as complete closure of all external fistula openings with no drainage, without development of new fistulas and no evidence of underlying fluid collections on MRI.a Combined fistula remission was achieved by 28.3% of patients receiving TREMFYA 100mg every 8 weeks and 27.0% of patients receiving TREMFYA 200mg every 4 weeks, compared with 10.3% for placebo.
Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA in CD.
“The pain, swelling and persistent drainage associated with perianal fistulizing Crohn’s disease can be profoundly disruptive to patients’ daily lives,” said Laurent Peyrin-Biroulet, study investigator.
“Achieving durable fistula closure without repeated surgical interventions remains a significant unmet need. The results from the FUZION study demonstrate the ability of TREMFYA to achieve combined fistula remission, which is an exciting step forward for patients, expanding what’s possible for managing this debilitating and chronic condition.”
“It has been more than two decades since a highly rigorous study has been dedicated to perianal fistulizing Crohn’s disease, a very difficult-to-treat and complex manifestation of this already challenging condition,” said Ludovic de Beaucoudrey, J&J innovative medicine vice president, immunology, Global Medical Affairs, Gastroenterology and Autoantibody.
“Building on decades of experience in immunology, Johnson & Johnson continues to address areas of significant unmet need, and the FUZION study reflects our commitment to delivering meaningful, evidence-based advances for patients and the healthcare providers who care for them.”
A fistula is an abnormal connection or tunnel that develops between the intestine and another organ or the skin, typically arising when inflammation causes ulceration in the intestinal wall or surrounding tissue. Over time, these ulcers may penetrate the full thickness of the bowel, forming a channel that allows infected material to drain. Perianal fistulizing Crohn’s disease affects nearly 25% of patients with CD and represents a severe, often debilitating manifestation of the disease that has profound impacts on a person’s physical and mental health. It is characterised by pain, swelling, persistent drainage, recurrent abscesses, and a frequent need for surgical intervention.
Johnson & Johnson is also initiating the CHARGE study, the first head-to-head study of IL-23 inhibitors in IBD, which will evaluate TREMFYA compared to risankizumab in treatment of Crohn’s disease. Trial sites are now open for patient enrolment.