J&J's Tremfya shows sustained remission in Crohn's at 3 years

Johnson & Johnson (NYSE: JNJ) announced three-year data from the Phase 3 GALAXI 2 and 3 studies evaluating Tremfya (guselkumab) in adults with moderately to severely active Crohn's disease, presented at the American College of Gastroenterology 2026 Annual Scientific Meeting.

At Week 144, data from the long-term extension showed that 94% of patients receiving Tremfya 100 mg every eight weeks and 91% receiving 200 mg every four weeks achieved clinical remission. Endoscopic remission was reported in 52% and 61% of patients in the respective dosing groups. Both groups showed an 88% rate of 90-day corticosteroid-free clinical remission. Overall, 74% of Tremfya-treated patients remained on treatment through three years.

Safety findings through Week 144 were consistent with the drug's previously established safety profile in Crohn's disease, according to the company's statement.

"In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients," said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago, who is a paid consultant for Johnson & Johnson.

The GALAXI program is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to evaluate Tremfya's efficacy and safety in patients with moderately to severely active Crohn's disease. The long-term extension will continue to assess outcomes through five years.

Tremfya is approved in the U.S. for adults with moderately to severely active Crohn's disease, among other indications. The drug is manufactured by Janssen Biotech, Inc., a Johnson & Johnson subsidiary.

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