Johnson & Johnson's Tremfya Shows 48-Week Fistula Remission

Johnson & Johnson announced October 19, 2026, 1-year results from the phase 3 FUZION study showing guselkumab (Tremfya) maintained or improved combined fistula remission through week 48 in adults with Crohn disease with perianal fistula, across both maintenance dosing regimens.¹ Among patients receiving guselkumab 100 mg subcutaneously every 8 weeks, combined fistula remission increased from 28% at week 24 to 35% at week 48. Results among patients receiving 200 mg every 4 weeks remained consistent through week 48.¹

More than 90% of randomized patients, including both biologic-naive and biologic-experienced patients, completed treatment through week 48, and safety findings were consistent with guselkumab's established profile in Crohn disease.¹ The late-breaking findings are being presented at the 2026 United European Gastroenterology Week.¹

“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 study investigator, in a company press release.¹ “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.”

How does the trial's design support these durability findings?

FUZION is a randomized, placebo-controlled, double-blind, phase 3 study that randomized patients 2:2:1 to guselkumab 200 mg intravenously at weeks 0, 4, and 8, followed by 100 mg subcutaneously every 8 weeks, or the same intravenous induction followed by 200 mg subcutaneously every 4 weeks, or placebo.¹ Enrolled patients had one or more active draining perianal fistulas confirmed by blinded central magnetic resonance imaging (MRI), a Crohn Disease Activity Index below 350, and an inadequate response to corticosteroids, immunomodulators, or up to 2 advanced therapy classes.¹ ClinicalTrials.gov lists an estimated enrollment of 280 patients for the trial.² Combined fistula remission, the study's composite endpoint, required complete closure of all external fistula openings without drainage, new fistulas, or MRI-confirmed fluid collections.¹

How do these results compare with the trial's week 24 data?

The week 48 findings build on previously reported week 24 results, in which 28.3% of patients receiving guselkumab 100 mg every 8 weeks and 27.0% receiving 200 mg every 4 weeks achieved combined fistula remission, compared with 10.3% receiving placebo, making guselkumab the only interleukin-23 inhibitor to demonstrate efficacy in a dedicated, randomized, placebo-controlled trial in this patient population.³ Perianal fistula affects nearly 25% of patients with Crohn disease and is associated with pain, drainage, infection, and substantial impairment in quality of life.⁴

“These one-year findings expand the evidence for TREMFYA in perianal fistulizing Crohn's disease where long-term treatment options remain limited,” said David M. Lee, MD, PhD, global immunology therapeutic area head at Johnson & Johnson, in the release.¹

What are the limitations?

These are late-breaking conference findings rather than peer-reviewed, published results, and Johnson & Johnson's announcement does not report numerical safety event rates for the week 48 analysis.¹ Dr Peyrin-Biroulet is a paid consultant to Johnson & Johnson, a disclosure the company noted was not compensated for this specific media work.¹ Guselkumab's dual-acting mechanism, which the company describes as also binding CD64 on IL-23-producing cells, is based on in vitro studies only, and the clinical significance of this binding is not known.¹ The company's enrollment figure for FUZION has not been independently confirmed beyond the estimated count listed in the trial's registry record.²

References

1. Johnson & Johnson. 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. Press release. Published October 19, 2026. Accessed October 19, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-new-data-showing-tremfya-guselkumab-is-the-only-il-23-to-deliver-durable-fistula-remission-through-48-weeks-in-crohns-disease-with-perianal-fistula
2. A study of guselkumab in participants with fistulizing, perianal Crohn's disease (FUZION CD). ClinicalTrials.gov; NCT05347095. Updated September 25, 2026. Accessed October 19, 2026. https://clinicaltrials.gov/study/NCT05347095
3. Peyrin-Biroulet L, Jairath V, Hart A, et al. Guselkumab for perianal fistulizing Crohn's disease: week 24 results from the phase 3, randomized, double-blind, placebo-controlled, multicenter FUZION study. Abstract 1058b. Presented at Digestive Disease Week; Chicago, Ill.; May 2-5, 2026. https://www.giejournal.org/article/S0016-5107(26)06685-X/abstract
4. Anandabaskaran S, Hanna L, Iqbal N, et al. Where are we and where to next?-the future of perianal Crohn's disease management. J Clin Med. 2023;12(19):6379. doi:10.3390/jcm12196379