SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) reported that its Crohn’s disease treatment Tremfya sustained or improved fistula remission through 48 weeks in a Phase 3 clinical trial, extending evidence of the drug’s effectiveness against a debilitating complication of the inflammatory bowel disease.
The findings, presented at the 2026 United European Gastroenterology Week, showed that 35% of patients receiving Tremfya at 100 milligrams every eight weeks achieved combined fistula remission at Week 48, up from 28% at Week 24.
The results come from the FUZION trial, which evaluated guselkumab, marketed as Tremfya, in adults with Crohn’s disease complicated by perianal fistulas. These abnormal passages develop near the anus and can cause persistent drainage, pain and other complications.
The study measured combined fistula remission using both clinical examinations and radiologic assessments, providing a broader evaluation of treatment response than symptom improvement alone.
Patients receiving the higher maintenance regimen of 200 milligrams every four weeks maintained consistent remission results through Week 48, according to the company.
Similar patterns were observed in clinically assessed fistula remission, while more than 90% of randomized participants completed treatment through the 48-week period.
The one-year findings extend previously reported results from the trial’s placebo-controlled assessment at Week 24.
At that point, combined fistula remission was achieved by 28% of patients receiving Tremfya 100 milligrams every eight weeks and 27% receiving 200 milligrams every four weeks, compared with 10% receiving placebo.
Those results established a statistically evaluated treatment benefit in a dedicated randomized, placebo-controlled study involving patients with perianal fistulizing Crohn’s disease.
The trial included patients who had previously received biologic treatments as well as those who had not, addressing a population in which treatment responses can be difficult to sustain.
“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, a FUZION study investigator.
Peyrin-Biroulet said the 48-week findings demonstrated that patients maintained or improved upon the clinical benefits observed at Week 24.
Johnson & Johnson characterized FUZION as the first dedicated trial of its kind in approximately 20 years and said Tremfya is the only interleukin-23 inhibitor to demonstrate efficacy in a randomized, placebo-controlled study specifically involving Crohn’s disease patients with perianal fistulas.
Tremfya targets interleukin-23, an immune-system protein involved in inflammatory processes associated with Crohn’s disease and other immune-mediated conditions.
The longer-term results are relevant because perianal fistulas can persist despite treatment of intestinal inflammation, making sustained remission a significant clinical objective.
Safety findings through Week 48 were consistent with Tremfya’s previously established safety profile in Crohn’s disease, according to Johnson & Johnson.
The company did not report new safety concerns in the one-year findings.
The latest results establish continued treatment responses through 48 weeks but do not provide a new placebo-controlled comparison at that time point in the information released by the company.
David M. Lee, Johnson & Johnson’s global immunology therapeutic area head, said the findings expand the evidence supporting Tremfya in patients with perianal fistulizing Crohn’s disease, where long-term treatment options remain limited.
The data add to Johnson & Johnson’s clinical evidence for Tremfya in moderately to severely active Crohn’s disease, particularly among patients with complications that can require prolonged treatment and specialist care.
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