Johnson & Johnson (NYSE: JNJ) reported that its drug TREMFYA demonstrated efficacy in treating perianal fistulizing Crohn's disease in a Phase 3 clinical trial. The FUZION study showed that 28.3% of patients receiving TREMFYA 100 mg every 8 weeks and 27.0% of patients receiving 200 mg every 4 weeks achieved combined fistula remission at Week 24, compared to 10.3% for placebo.

Combined fistula remission was defined as complete external closure of draining fistulas and absence of fluid collection on MRI. Both dosing regimens showed statistically significant treatment differences versus placebo, with p-values of 0.007 and 0.013 respectively.

The study represents what Johnson & Johnson claims is the first randomized controlled trial of an approved inflammatory bowel disease therapy to demonstrate efficacy in adults with active perianal fistulizing Crohn's disease in 20 years. Perianal fistulizing Crohn's disease affects approximately 25% of patients with Crohn's disease.

TREMFYA (guselkumab) is a monoclonal antibody designed to block IL-23 and bind to CD64. The drug is currently approved in the United States for treating moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease in adults and children 6 years and older.

The FUZION study enrolled patients with one or more active draining perianal fistulas confirmed by MRI review. Adverse events through 24 weeks were consistent with TREMFYA's known safety profile in Crohn's disease, according to the company statement.

Johnson & Johnson presented these findings at Digestive Disease Week 2026 among 32 company-sponsored abstracts. The company is also initiating the CHARGE study, which will compare TREMFYA to risankizumab in treating Crohn's disease.