Johnson & Johnson (NYSE: JNJ) announced Phase 3 data showing that Tremfya (guselkumab) achieved consistent combined fistula remission outcomes across multiple patient subgroups with Crohn's disease and perianal fistula, according to a company press release.

The prespecified subgroup analyses from the FUZION study were presented at the American College of Gastroenterology 2026 Annual Scientific Meeting. In the overall study population, 28% of patients receiving Tremfya 100 mg every eight weeks and 27% receiving Tremfya 200 mg every four weeks achieved combined fistula remission at Week 24, compared with 10% receiving placebo.

The new subgroup analyses showed the following Week 24 combined fistula remission rates versus placebo:

• Patients with greater luminal disease activity at baseline: 30% and 21% with the two Tremfya dosing regimens, 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 Tremfya's known safety profile in Crohn's disease.

The FUZION study is described as the first dedicated Phase 3 randomized, placebo-controlled trial in adults with Crohn's disease with perianal fistula in more than 20 years. Perianal fistula affects nearly 25% of patients with Crohn's disease, according to the company.

"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, of the Icahn School of Medicine at Mount Sinai Health System, who is a paid consultant for Johnson & Johnson.

Tremfya is currently approved in the U.S. for moderately to severely active Crohn's disease, among other indications. It is manufactured by Janssen Biotech, Inc.