Johnson & Johnson (NYSE: JNJ) announced one-year results from its Phase 3 FUZION study showing that Tremfya (guselkumab) maintained or improved fistula remission through 48 weeks in adults with Crohn's disease with perianal fistula. The findings were presented at the 2026 United European Gastroenterology Week.

Among patients receiving Tremfya 100 mg every 8 weeks, combined fistula remission — defined as complete closure of all external fistula openings with no drainage and no evidence of underlying fluid collections on MRI — increased from 28% at Week 24 to 35% at Week 48. Results among patients receiving Tremfya 200 mg every 4 weeks remained consistent through Week 48. More than 90% of all randomized patients completed treatment through the full 48-week period.

The 48-week data build on previously reported Week 24 results, which showed that 28% of patients on the 100 mg regimen and 27% on the 200 mg regimen achieved combined fistula remission, compared with 10% receiving placebo.

"Perianal fistula remain one of the most debilitating complications of Crohn's disease, where achieving durable disease control beyond symptom improvement is a challenge," said Laurent Peyrin-Biroulet, MD, PhD, a paid Johnson & Johnson consultant and study investigator. "The latest findings from the FUZION study, which is the first of its kind in 20 years, shows that patients treated with Tremfya maintained or improved upon the clinical benefits observed at Week 24."

Safety findings through Week 48 were consistent with Tremfya's previously established safety profile in Crohn's disease. The study enrolled both bio-naïve and bio-experienced patients with one or more active draining perianal fistulas confirmed by MRI.

Tremfya is currently approved in the U.S. for moderately to severely active Crohn's disease, among other indications. The legal manufacturer is Janssen Biotech, Inc., a Johnson & Johnson company.