Johnson & Johnson announces new data showing TREMFYA® (guselkumab) is the only IL-23 to deliver durable fistula remission through 48 weeks in Crohn's disease with perianal fistula
Key Highlights
- ➤TREMFYA 100 mg q8w remission rose from 28% at Week 24 to 35% at Week 48
- ➤TREMFYA 200 mg q4w remission remained consistent through Week 48
- ➤Over 90% of randomized patients completed FUZION treatment through Week 48
- ➤Week 24 remission reached 28% and 27% for TREMFYA versus 10% for placebo
- ➤TREMFYA became the only IL-23 inhibitor with dedicated randomized trial efficacy
Expert Statements
Laurent Peyrin-Biroulet, Study investigator
“Perianal fistula remain one of the most debilitating complications of Crohn's disease, where achieving durable disease control beyond symptom improvement is a challenge”
Laurent Peyrin-Biroulet, 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, providing encouraging evidence for its use in this patient population.”
David M. Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson
“These one-year findings expand the evidence for TREMFYA in perianal fistulizing Crohn's disease where long-term treatment options remain limited”
David M. Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson
“Building on our longstanding expertise in immune-mediated diseases, we are committed to studying TREMFYA across the full spectrum of moderately to severely active Crohn's disease and generating evidence that may transform outcomes for patients, including those facing some of its most challenging complications.”
Johnson & Johnson announces new data showing TREMFYA® (guselkumab) is the only IL-23 to deliver durable fistula remission through 48 weeks in Crohn's disease with perianal fistula PR Newswire
* TREMFYA maintained combined fistula remission through Week 48 across both maintenance dose regimens, including an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg dose group * These findings build on the Phase 3 clinical program, demonstrating efficacy in a dedicated, randomized, placebo-controlled trial in patients with this debilitating and challenging manifestation of Crohn's disease SPRING HOUSE, Pa., Oct. 19, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced one-year results from the Phase 3 FUZION study showing TREMFYA(®) (guselkumab) maintained or improved fistula remission through 48 weeks in adults with Crohn's disease (CD).(1) The findings build on the previously reported Week 24 results and further support the use of TREMFYA in one of the most difficult-to-treat manifestations of CD (2). The late-breaking findings are being presented at the 2026 United European Gastroenterology Week (UEG Week).
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