TREMFYA (guselkumab) - (FUZION)

Oct. 12, 2026: Johnson & Johnson (NYSE: JNJ) reported prespecified subgroup analyses from the Phase 3 FUZION trial of TREMFYA (guselkumab) in adults with Crohn’s disease with perianal fistula, presented at the ACG 2026 Annual Scientific Meeting. The subgroup data built on previously reported Week 24 overall results, where combined fistula remission was achieved in 28% of patients on TREMFYA 100 mg SC q8w and 27% on 200 mg SC q4w versus 10% on placebo.

In subgroup analyses at Week 24, remission rates favored TREMFYA over placebo in patients with baseline CDAI at least 220 (30% and 21% vs 0%), prior biologic exposure (21% and 29% vs 5%), proctitis at baseline (26% and 27% vs 12%), and without proctitis (29% and 27% vs 10%). Combined fistula remission was defined as closure of all external fistula openings with no drainage, no new fistulas, and no underlying fluid collections on MRI.

The company said adverse events were consistent with TREMFYA’s known Crohn’s disease safety profile. The release describes FUZION as the first dedicated Phase 3 randomized, placebo-controlled trial in this setting in more than 20 years.