Johnson & Johnson’s Tremfya becomes first IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn’s disease

Johnson & Johnson has announced results from the Phase 3 FUZION study evaluating Tremfya (guselkumab) in adults with active perianal fistulizing Crohn’s disease, marking the first randomised controlled trial of an approved inflammatory bowel disease therapy to demonstrate efficacy in this indication in over 20 years. The late-breaking data were presented at Digestive Disease Week 2026 in Chicago.

Perianal fistulizing Crohn’s disease is one of the most debilitating and difficult-to-treat manifestations of Crohn’s disease, characterised by abnormal tunnels forming between the bowel and surrounding tissue. Achieving durable fistula closure without repeated surgical intervention remains one of the most significant unmet needs in gastroenterology.

Tremfya met the primary endpoint of combined fistula remission at Week 24, defined as complete external closure of all draining fistulas with no new fistula development and no evidence of underlying fluid collections on MRI. This is a highly stringent composite endpoint reflecting both clinical and radiological evidence of remission. Combined fistula remission was achieved by 28.3% of patients receiving Tremfya 100mg every eight weeks and 27.0% receiving Tremfya 200mg every four weeks, compared with just 10.3% for placebo. Both dosing regimens achieved statistically significant treatment differences versus placebo. The adverse event profile through Week 24 was consistent with the established safety profile of Tremfya in Crohn’s disease.

Laurent Peyrin-Biroulet, a study investigator, described the burden the condition places on patients and the significance of achieving fistula closure: “The pain, swelling and persistent drainage associated with perianal fistulizing Crohn’s disease can be profoundly disruptive to patients’ daily lives. 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.”

Ludovic de Beaucoudrey, Vice President of Immunology and Global Medical Affairs at Johnson & Johnson Innovative Medicine, placed the findings in the context of the company’s broader gastroenterology commitment: “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. 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.”

Tremfya is now the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn’s disease, adding to a growing body of evidence supporting the therapy across manifestations of inflammatory bowel disease.

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Related Topics and Keywords

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