Johnson & Johnson reported positive Phase 3 FUZION results showing TREMFYA significantly improved combined fistula remission rates versus placebo in adults with active perianal fistulizing Crohn’s disease, a severe complication with limited treatment options.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson announced positive results from the Phase 3 FUZION study evaluating TREMFYA (guselkumab) in adults with active perianal fistulizing Crohn’s disease, a severe and difficult-to-treat complication of Crohn’s disease.
The late-breaking findings were presented at the 2026 Digestive Disease Week (DDW) meeting and showed significantly higher rates of combined fistula remission with TREMFYA compared with placebo.
The Phase 3 FUZION trial (NCT05347095) enrolled patients with one or more active draining perianal fistulas who had shown inadequate response to corticosteroids, immunomodulators, or up to two advanced therapy classes.
At Week 24, the study met its primary endpoint of combined fistula remission, defined as complete closure of all external fistula openings with no drainage, no new fistulas, and no evidence of fluid collections on MRI. Combined fistula remission was achieved in 28.3% of patients receiving TREMFYA 100 mg every eight weeks and 27.0% of patients receiving TREMFYA 200 mg every four weeks, compared with 10.3% in the placebo group. Both dosing regimens demonstrated statistically significant improvements versus placebo, with p-values of 0.007 and 0.013, respectively.
According to the company, the study represents the first randomized controlled trial of an approved inflammatory bowel disease therapy in nearly 20 years to demonstrate efficacy in adults with active perianal fistulizing Crohn’s disease. Safety findings through 24 weeks were consistent with the known safety profile of TREMFYA in Crohn’s disease.
Study investigator Laurent Peyrin-Biroulet, MD, PhD, said the persistent drainage, pain, and swelling associated with perianal fistulizing Crohn’s disease can significantly affect patients’ daily lives. He noted that achieving durable fistula closure without repeated surgical interventions remains a major unmet need and said the FUZION findings expand treatment possibilities for patients with this chronic condition.
Ludovic de Beaucoudrey, PhD, Vice President of Immunology Global Medical Affairs Gastroenterology and Autoantibody at Johnson & Johnson Innovative Medicine, said the study reflects the company’s ongoing efforts to address difficult manifestations of Crohn’s disease through evidence-based treatment approaches.
Perianal fistulizing Crohn’s disease affects nearly 25% of patients with Crohn’s disease and is associated with pain, recurrent abscesses, persistent drainage, and frequent surgical interventions. A fistula forms when inflammation creates an abnormal tunnel between the intestine and nearby organs or skin.
Johnson & Johnson said it has also initiated the CHARGE study (NCT07499232), which it describes as a head-to-head study of IL-23 inhibitors in inflammatory bowel disease comparing TREMFYA with risankizumab in Crohn’s disease. Patient enrollment is underway.
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About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.