J&J Tremfya Data Shows Fistula Remission in Crohn’s Subgroups

Johnson & Johnson presented new Phase 3 subgroup data from the FUZION study at the American College of Gastroenterology 2026 Annual Scientific Meeting, demonstrating consistent fistula remission outcomes with TREMFYA across complex Crohn's disease patient populations. The findings show the efficacy of the IL-23 inhibitor in patient demographics that have historically proved difficult to treat.

“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.

In the overall study population from [the Johnson & Johnson press release], 28% of patients receiving TREMFYA 100 mg administered every eight weeks (q8w) and 27% receiving TREMFYA 200 mg administered every four weeks (q4w) achieved combined fistula remission at Week 24. This compares with 10% of patients receiving a placebo, establishing TREMFYA as the first and only IL-23 inhibitor to demonstrate efficacy in a dedicated, randomized, placebo-controlled trial for this specific patient group.

Defining Fistula Remission and Trial Design

Clinical investigators evaluated outcomes using a strict definition of combined fistula remission. The endpoint required complete closure of all external fistula openings with no drainage, no development of new fistulas, and an absence of underlying fluid collections confirmed on magnetic resonance imaging (MRI).

The FUZION study marks the first dedicated Phase 3 randomized, placebo-controlled trial in adults managing Crohn's disease with perianal fistula in more than two decades. Perianal fistulas affect nearly 25% of all patients diagnosed with Crohn's disease, creating significant clinical management challenges.

Subgroup Efficacy and Patient Demographics

New subgroup analyses presented at the meeting detailed Week 24 outcomes across specific clinical profiles:

• Greater luminal disease activity: 30% for the 100 mg cohort and 21% for the 200 mg cohort achieved remission, compared to 0% for placebo.
• Prior biologic exposure: 21% for the 100 mg dose and 29% for the 200 mg dose reached remission, versus 5% for placebo.
• Proctitis at baseline: 26% (100 mg) and 27% (200 mg) achieved remission, compared to 12% for placebo.
• Without proctitis: 29% (100 mg) and 27% (200 mg) reached remission, compared to 10% for placebo.

“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.