Spring House, Pennsylvania, U.S., October 12, 2026
Johnson & Johnson has announced new findings from the Phase III GALAXI clinical development program showing consistent rates of perianal fistula remission with TREMFYA® (guselkumab) across key patient subgroups with moderately to severely active Crohn’s disease. The findings add to the growing clinical evidence for guselkumab, an interleukin-23 (IL-23) inhibitor approved for certain inflammatory conditions, including Crohn’s disease in adults. Perianal fistulas are a serious complication of Crohn’s disease in which abnormal passages develop between the intestine and the skin near the anus. These fistulas can cause pain, drainage, recurrent infections and a substantial reduction in quality of life. Treatment can be challenging and may require a combination of medication, surgical procedures and long-term monitoring. The new subgroup analysis examined whether fistula outcomes were consistent across different patient characteristics, including prior treatment exposure and baseline disease features. The findings suggest that guselkumab may provide a treatment option for patients with Crohn’s disease complicated by perianal fistulas, although subgroup analyses do not independently establish efficacy for every individual patient group.
FUZION Trial Shows Consistent Results Across Patient Groups
The new prespecified subgroup analyses from the Phase III FUZION study evaluated combined fistula remission at Week 24 among adults with active perianal fistulizing Crohn’s disease. Combined fistula remission was defined as complete closure of all external fistula openings without drainage, no new fistulas and no underlying fluid collections on MRI. In the overall study population, remission was achieved by 28% of patients receiving TREMFYA 100 mg every eight weeks and 27% receiving 200 mg every four weeks, compared with 10% receiving placebo. Results also favored TREMFYA among patients with greater intestinal disease activity at baseline, with remission rates of 30% and 21% for the two dosing regimens, respectively, versus 0% with placebo. Among patients previously exposed to biologic therapies, the respective rates were 21% and 29%, compared with 5% for placebo. The findings were also consistent among patients with and without proctitis, an inflammation of the rectal lining. Remission rates in those with proctitis were 26% and 27%, compared with 12% for placebo, while rates in those without proctitis were 29% and 27%, compared with 10%. These results support a consistent treatment effect across the subgroups studied, although subgroup findings should be interpreted in the context of the overall trial and the size of each patient group.
Johnson & Johnson Addresses an Unmet Need in Crohn’s Disease
Crohn’s disease is a chronic inflammatory bowel disease that can affect different parts of the gastrointestinal tract. Perianal fistulas are among its most difficult complications, affecting approximately one in four people with Crohn’s disease and potentially causing persistent drainage, pain, recurrent abscesses and repeated surgical procedures. The FUZION trial was designed specifically to study this challenging manifestation in adults who had not responded adequately to, or had difficulty tolerating, prior conventional or advanced treatments. TREMFYA is a monoclonal antibody that blocks interleukin-23 (IL-23), an inflammatory signaling protein involved in immune-mediated diseases. It also binds to CD64, a receptor found on cells that produce IL-23, although the clinical significance of this additional mechanism remains under investigation. The company reported that adverse events in the subgroup analyses were consistent with TREMFYA’s established safety profile in Crohn’s disease. The new findings add evidence for guselkumab in perianal fistulizing Crohn’s disease, but the results do not guarantee remission for individual patients. Ongoing clinical evaluation and appropriate medical assessment remain important in managing this complex condition.
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Source: Johnson & Johnson press release
