Johnson & Johnson announces results from Phase 3 FUZION study of tremfya

Johnson & Johnson announced results from the Phase 3 FUZION study evaluating TREMFYA in adults with active perianal fistulizing Crohn’s disease. At Week 24, TREMFYA demonstrated significantly higher rates of combined fistula remission, a highly stringent endpoint defined as complete external closure of draining fistulas and absence of fluid collection on MRI, compared to placebo. Remission in patients with this complicated manifestation remains difficult to achieve, and this is the first randomized control trial of an approved therapy in inflammatory bowel disease that demonstrates efficacy in adults with active perianal fistulizing Crohn’s disease in 20 years. These late-breaking data are among the 32 company-sponsored abstracts at Digestive Disease Week 2026. TREMFYA met the primary endpoint of combined fistula remission at Week 24, defined as complete closure of all external fistula openings with no drainage, without development of new fistulas and no evidence of underlying fluid collections on MRI. Combined fistula remission was achieved by 28.3% of patients receiving TREMFYA 100 mg every 8 weeks and 27.0% of patients receiving TREMFYA 200 mg every 4 weeks, compared with 10.3% for placebo. The treatment differences versus placebo were statistically significant for both the 100 mg q8w and 200 mg q4w dosing regimens. Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA in CD.