Johnson & Johnson reports consistent TREMFYA fistula remission across Crohn's subgroups

In the overall study population, combined fistula remission was 28% with the 100 mg every eight weeks dose and 27% with the 200 mg every four weeks dose, versus 10% with placebo at Week 24.

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Johnson & Johnson said on October 12, 2026, that new Phase 3 data from the FUZION study showed consistent combined fistula remission with TREMFYA (guselkumab) across clinically important subgroups of adults with Crohn's disease with perianal fistula. The prespecified subgroup analyses are being presented at the American College of Gastroenterology 2026 Annual Scientific Meeting and build on previously reported Week 24 results from the overall study population.

In the subgroup analyses, patients with greater luminal disease activity at baseline (CDAI of 220 or more) reached combined fistula remission of 30% with the 100 mg subcutaneous every eight weeks dose and 21% with the 200 mg subcutaneous every four weeks dose, versus 0% with placebo. Patients with prior biologic exposure reached 21% and 29%, respectively, versus 5% with placebo.

Remission rates were also reported for patients with and without proctitis at baseline. Patients with proctitis reached 26% and 27%, respectively, versus 12% with placebo, and patients without proctitis reached 29% and 27%, respectively, versus 10% with placebo. Johnson & Johnson said adverse events were consistent with the known safety profile of TREMFYA in Crohn's disease.

Key facts

Study
FUZION, Phase 3 randomized, placebo-controlled trial
Overall remission at Week 24
28% with TREMFYA 100 mg every eight weeks; 27% with TREMFYA 200 mg every four weeks; 10% with placebo
Prior biologic exposure
21% and 29%, respectively, versus 5% with placebo
Meeting
American College of Gastroenterology 2026 Annual Scientific Meeting
Announced
October 12, 2026

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Source: The company's release on PR Newswire, October 12, 2026.

Written by GetSignal with AI from the company's press release.

Not investment advice.

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