J&J says Tremfya met Phase 3 endpoint in perianal fistulizing Crohn’s disease

Johnson & Johnson said Tremfya (guselkumab) met the primary endpoint in a Phase 3 study for adults with active perianal fistulizing Crohn’s disease. The FUZION study showed that 28.3% of patients receiving Tremfya 100 mg every eight weeks and 27.0% receiving 200 mg every four weeks achieved combined fistula remission at Week 24, compared with 10.3% for placebo.

The treatment differences versus placebo were statistically significant for both dosing regimens (p=0.007 and p=0.013, respectively). Combined fistula remission was defined as complete external closure of draining fistulas with no drainage, no development of new fistulas, and no evidence of fluid collections on MRI. The results were presented at Digestive Disease Week 2026.

The FUZION study is a randomized, placebo-controlled, double-blind, multicenter Phase 3 trial. Patients enrolled had one or more active draining perianal fistulas confirmed by MRI and inadequate response to oral corticosteroids or other therapies. Patients were randomized to receive either Tremfya at different dosing regimens or placebo.

Perianal fistulizing Crohn’s disease affects nearly 25% of patients with Crohn’s disease. A fistula is an abnormal connection that develops between the intestine and another organ or the skin when inflammation causes ulceration in the intestinal wall.

Adverse events through 24 weeks were consistent with the known safety profile of Tremfya in Crohn’s disease, according to the company. Tremfya is currently approved in the U.S. to treat 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 certain pediatric patients.