Johnson & Johnson Reports 96-Week Data Showing Long-Term Efficacy of Tremfya in Crohn’s Disease

Johnson & Johnson (J&J) has announced new 96-week data from the long-term extensions (LTE) of its Phase 3 GRAVITI, GALAXI 2, and GALAXI 3 studies. The results demonstrate the sustained efficacy and safety of Tremfya (guselkumab) in adults with moderately to severely active Crohn’s disease (CD) over a two-year period.

These findings are among 23 abstracts presented by the company at the 2025 American College of Gastroenterology (ACG) Annual Scientific Meeting.

Dual-Acting Mechanism of Tremfya

Tremfya is the first and only approved dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine involved in driving immune-mediated diseases such as Crohn’s disease and ulcerative colitis.

This dual action was demonstrated in in vitro studies, highlighting Tremfya’s unique ability to target inflammation at its cellular source.

Key 96-Week Findings

At Week 96, patients treated with Tremfya via subcutaneous (SC) or intravenous (IV) induction followed by SC maintenance showed:

• High rates of clinical remission
• Endoscopic response and remission
• Sustained deep remission

Safety outcomes through 96 weeks were consistent with Tremfya’s established safety profile from earlier studies.

Expert Commentary

“Crohn’s disease is a chronic condition that can greatly impact a patient’s quality of life,” said Dr. David Rubin, Director of the Inflammatory Bowel Disease Center, University of Chicago.

“These results show that guselkumab can provide endoscopic remission through either subcutaneous or intravenous induction, allowing people with moderate to severely active Crohn’s disease to manage their condition with greater independence and confidence.”

Study Details

GRAVITI Study

A randomized, double-blind, placebo-controlled Phase 3 trial, GRAVITI evaluated SC induction therapy with Tremfya (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who had an inadequate response or intolerance to conventional or biologic therapies.

Participants were maintained on either:

• 200 mg SC every 4 weeks, or
• 100 mg SC every 8 weeks

The long-term extension (LTE) phase continues to assess clinical and endoscopic outcomes over two years, and safety outcomes up to five years.

GALAXI Programme

The GALAXI clinical programme (GALAXI 1, 2, and 3) assessed IV induction followed by SC maintenance in patients with moderate-to-severe Crohn’s disease. Tremfya was compared with placebo and Stelara (ustekinumab).

Previously published pooled data showed Tremfya to be superior to Stelara for all endoscopic endpoints at Week 48 — the only IL-23 inhibitor to achieve this in a double-blinded registrational trial.

J&J’s Commitment to IBD Treatment

“As the only IL-23 inhibitor approved for both subcutaneous and intravenous induction in Crohn’s disease—and now also in ulcerative colitis—Tremfya provides patients and their providers with meaningful choices,” said Dr. Esi Lamousé-Smith, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine.

“These results reinforce our commitment to delivering innovations that achieve deep, sustained remission and address the diverse needs of people living with IBD.”

About Tremfya

Tremfya (guselkumab) is a fully human monoclonal antibody developed by Johnson & Johnson. It is approved in the U.S., Europe, Canada, Japan, and several other countries for the treatment of:

• Moderate-to-severe plaque psoriasis (adults and children ≥6 years, ≥40 kg)
• Active psoriatic arthritis (adults and children ≥6 years, ≥40 kg)
• Moderately to severely active ulcerative colitis (adults)
• Moderately to severely active Crohn’s disease (adults)

The legal manufacturer is Janssen Biotech, Inc., and Johnson & Johnson holds exclusive worldwide marketing rights.

About Crohn’s Disease

Crohn’s disease is a chronic inflammatory disorder of the gastrointestinal tract and one of the two major forms of inflammatory bowel disease (IBD). It affects approximately 3 million Americans and 4 million people across Europe.

Symptoms may include:

• Abdominal pain and tenderness
• Frequent diarrhea
• Rectal bleeding
• Weight loss and fever

There is no known cure, but effective treatments can help manage inflammation and improve quality of life.

About Johnson & Johnson

Johnson & Johnson is a global healthcare innovator focused on developing solutions that prevent, treat, and cure complex diseases. The company’s mission is to advance smarter, less invasive, and more personalized healthcare solutions for people worldwide.

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