Johnson & Johnson Reports 48-Week Tremfya Results in Phase 3 Crohn's Disease Fistula Study

Johnson & Johnson (NYSE:JNJ) reported 48-week results from its Phase 3 FUZION study evaluating Tremfya (guselkumab) in adults with Crohn’s disease and active perianal fistulas, showing that fistula remission rates were maintained or increased during continued treatment.

The findings, presented at the 2026 United European Gastroenterology Week, included data from patients receiving two different Tremfya dosing regimens.

Among patients treated with Tremfya 100 mg every eight weeks, the proportion achieving combined fistula remission increased from 28% at Week 24 to 35% at Week 48.

The company also reported that results for patients receiving Tremfya 200 mg every four weeks remained consistent through Week 48.

More than 90% of randomised participants completed the full 48-week treatment period.

FUZION Study Evaluates Perianal Fistula Remission

The Phase 3 FUZION study investigated the efficacy and safety of Tremfya in adults with Crohn’s disease complicated by perianal fistulas.

Perianal fistulas are abnormal connections that can develop between the intestinal tract and the skin surrounding the anus. They can cause drainage, pain and other complications in patients with Crohn’s disease.

The trial enrolled patients with at least one active draining perianal fistula confirmed by magnetic resonance imaging (MRI).

Participants included patients who had not previously received biological therapies, referred to as biologic-naïve patients, and those with previous exposure to biological treatments.

The study assessed combined fistula remission, defined as complete closure of all external fistula openings without drainage and no evidence of underlying fluid collections on MRI.

This measure combines clinical examination findings with imaging evidence to evaluate the condition of the fistulas.

Tremfya 100 mg Remission Rate Reaches 35% at Week 48

At Week 24, 28% of patients receiving Tremfya 100 mg every eight weeks achieved combined fistula remission.

By Week 48, the proportion had increased to 35%, representing a seven-percentage-point rise.

For patients receiving Tremfya 200 mg every four weeks, Johnson & Johnson reported that the treatment results remained consistent between Weeks 24 and 48.

The company did not provide a specific Week 48 remission percentage for the 200 mg group in the supplied announcement.

The latest findings extend the previously reported 24-week results, which demonstrated differences between the Tremfya treatment groups and placebo.

At Week 24, combined fistula remission was achieved by 28% of patients receiving the 100 mg regimen and 27% receiving the 200 mg regimen.

This compared with 10% of patients in the placebo group.

The 48-week findings provide additional information about outcomes during continued Tremfya treatment, although the supplied announcement does not include a Week 48 placebo comparison.

Investigator Comments on Longer-Term Treatment Outcomes

Laurent Peyrin-Biroulet, MD, PhD, a FUZION study investigator and paid consultant to Johnson & Johnson, commented on the findings.

“Perianal fistula remain one of the most debilitating complications of Crohn’s disease, where achieving durable disease control beyond symptom improvement is a challenge,” he said.

“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.”

The investigator’s comments reflect the clinical challenges associated with managing perianal fistulas and the potential relevance of sustained treatment responses.

The study’s 48-week data provide additional follow-up on patients who received Tremfya, including changes in combined remission rates over time.

Safety Findings Consistent With Established Profile

Johnson & Johnson reported that safety findings through Week 48 were consistent with Tremfya’s previously established safety profile in Crohn’s disease.

More than 90% of all randomised patients completed treatment through the full 48-week period.

The company did not disclose additional numerical safety findings, including detailed adverse event rates, in the supplied announcement.

Tremfya is a monoclonal antibody that targets interleukin-23, a protein involved in inflammatory processes.

The treatment is approved in the United States for moderately to severely active Crohn’s disease, among other indications.

The legal manufacturer of Tremfya is Janssen Biotech, Inc., a Johnson & Johnson company.

Johnson & Johnson Presents Additional Crohn’s Disease Data

The FUZION results contribute to the clinical evidence concerning guselkumab treatment in patients with Crohn’s disease and perianal fistulas.

The reported increase in combined remission from 28% to 35% between Weeks 24 and 48 in the 100 mg group indicates that a greater proportion of patients met the study’s remission criteria at the later assessment.

Results in the 200 mg group were reported as remaining consistent over the same period.

The study also included both biologic-naïve and biologic-experienced patients, providing data from participants with different treatment histories.

Further information, including detailed Week 48 results across both dosing groups and additional safety analyses, would help clarify the longer-term outcomes observed in the trial.

The findings were presented at the 2026 United European Gastroenterology Week and relate to an approved medicine being investigated for outcomes in a specific Crohn’s disease complication.

Johnson & Johnson stock price