SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) reported new Phase 3 clinical trial results showing sustained remission in patients receiving its Crohn’s disease treatment Tremfya for three years, alongside additional evidence of efficacy in patients with a difficult-to-treat complication of the disease.
The findings, presented at the American College of Gastroenterology’s 2026 Annual Scientific Meeting, add longer-term clinical evidence for guselkumab, marketed as Tremfya, as Johnson & Johnson expands research into its use across different manifestations of Crohn’s disease.
In the Phase 3 GALAXI 2 and GALAXI 3 studies, 94% of patients receiving Tremfya at 100 milligrams every eight weeks achieved clinical remission at Week 144, compared with 91% receiving 200 milligrams every four weeks.
Endoscopic remission, which measures intestinal inflammation through direct examination, was achieved by 52% and 61% of patients in the respective dosing groups.
Both treatment groups recorded 88% rates of clinical remission without corticosteroid use for at least 90 days.
The company reported that 74% of Tremfya-treated patients remained on treatment through three years. Safety findings were consistent with the drug’s established profile in Crohn’s disease.
The long-term results followed intravenous induction treatment and subsequent subcutaneous maintenance dosing.
The findings provide evidence of sustained disease control among patients in the long-term extension, although the reported three-year outcomes do not establish how the drug would perform against a competing treatment over the same period.
“In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients,” said David Rubin, director of the Inflammatory Bowel Disease Center at the University of Chicago.
Crohn’s disease is a chronic inflammatory condition affecting the digestive tract. Treatment generally focuses on controlling symptoms, reducing intestinal inflammation and maintaining remission because no cure is currently available.
Johnson & Johnson separately presented additional findings from its Phase 3 FUZION trial, which evaluated Tremfya in adults with Crohn’s disease complicated by perianal fistulas.
These abnormal connections near the anus can cause persistent drainage, pain, abscesses and other complications that may require surgery.
In the overall FUZION study population, 28% of patients receiving 100 milligrams of Tremfya every eight weeks and 27% receiving 200 milligrams every four weeks achieved combined fistula remission at Week 24.
That compared with 10% of patients receiving placebo.
The trial represents the first dedicated Phase 3 randomized, placebo-controlled study in adults with Crohn’s disease and perianal fistulas in more than two decades, according to Johnson & Johnson.
New prespecified subgroup analyses showed higher remission rates with Tremfya than placebo across several patient populations, including those previously treated with biologic medications.
Among patients with prior biologic exposure, combined fistula remission occurred in 21% of those receiving the lower maintenance dose and 29% receiving the higher dose, compared with 5% receiving placebo.
For patients with greater intestinal disease activity at baseline, remission rates were 30% and 21% across the respective Tremfya regimens, versus 0% with placebo.
Patients with proctitis, or inflammation of the rectum, recorded remission rates of 26% and 27% with Tremfya, compared with 12% for placebo.
Among patients without proctitis, the corresponding rates were 29% and 27%, versus 10% for placebo.
The subgroup findings were consistent with the overall trial results, although subgroup comparisons do not independently establish treatment superiority without consideration of sample sizes and statistical testing.
“Perianal fistula remain one of the most debilitating manifestations of moderate to severe Crohn’s disease and many patients continue to experience persistent drainage, pain and complications,” said Bruce Sands, a gastroenterology professor at the Icahn School of Medicine at Mount Sinai.
Sands, who is a paid consultant to Johnson & Johnson, described the subgroup findings as additional evidence supporting the drug’s potential use in patients with complex Crohn’s disease.
Johnson & Johnson reported no new safety concerns in the FUZION analyses, with adverse events consistent with Tremfya’s known safety profile.
Tremfya is a monoclonal antibody that inhibits interleukin-23, a signaling protein involved in inflammatory responses. The company also reports that the drug binds to CD64, a receptor found on certain immune cells, based on laboratory studies.
The combined findings strengthen the clinical evidence supporting Tremfya’s role in Crohn’s disease treatment, providing longer-term remission data and additional results in patients with perianal fistulas, a complication affecting nearly one-quarter of people with the condition.
The FUZION results also expand the evidence available for evaluating IL-23 inhibition in patients whose disease includes complications that can be difficult to manage with existing therapies.
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