Johnson & Johnson: TREMFYA sustains perianal fistula remission through 48 weeks in Phase 3 FUZION

Key one-year outcomes

The Phase 3 FUZION study showed TREMFYA maintained or improved combined fistula remission through 48 weeks in adults with Crohn’s disease with perianal fistula. Combined remission for the TREMFYA 100 mg every-8-weeks maintenance arm rose from 28% at Week 24 to 35% at Week 48; rates for the 200 mg every-4-weeks arm remained consistent through Week 48.

Study design and population

FUZION is a randomized, placebo-controlled, double-blind, multicenter Phase 3 trial. Patients were randomized 2:2:1 to receive TREMFYA with IV induction (200 mg at Weeks 0, 4, 8) followed by either 100 mg SC q8w or 200 mg SC q4w, or placebo. The randomized population included both bio-naïve and bio-experienced patients, and >90% of randomized patients completed treatment through Week 48.

Remission definitions and safety

Combined fistula remission required complete closure of all external openings with no drainage, no new fistulas and no MRI evidence of fluid collections; clinically assessed remission required 100% closure without drainage or new fistulas/abscesses. Safety findings through Week 48 were reported as consistent with the established safety profile of the medicine.

Context

Earlier Week 24 FUZION data showed 28% (100 mg q8w) and 27% (200 mg q4w) combined remission versus 10% for placebo, and the study is presented at UEG Week 2026.