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Crohn’s Disease Study Shows Positive Results for Johnson & Johnson’s TREMFYA® in Phase 3 Trial

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Johnson & Johnson has announced positive topline results from the pivotal Phase 3 GRAVITI study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active Crohn’s disease. The study achieved both co-primary endpoints, showing statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12. All remaining endpoints at weeks 12, 24, and 48 were also statistically significant compared to placebo.

This adds to the robust results seen in the GALAXI studies, which demonstrated superiority versus STELARA® (ustekinumab) in key endoscopic endpoints. These findings suggest TREMFYA® could be the only IL-23 inhibitor to offer both SC and IV induction options. Safety data from GRAVITI were consistent with TREMFYA®’s established safety profile. “The Phase 3 GRAVITI study showed promising results with SC induction, providing similar clinical benefits to IV induction seen in the GALAXI studies,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine.

“Having both SC and IV induction options offers versatility for patients and providers. TREMFYA® is poised to be the only IL-23 inhibitor to offer a full SC therapy for both induction and maintenance in Crohn’s disease.” Results from the GRAVITI study are being prepared for upcoming medical meetings and will be shared with health authorities in planned submissions. A separate study evaluating TREMFYA® SC induction therapy in ulcerative colitis is ongoing.

Crohn’s Disease Studies Evaluate Guselkumab Therapy in GRAVITI and GALAXI Trials

The GRAVITI program (NCT05197049) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating guselkumab SC induction therapy (400 mg at weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced inadequate response to conventional or biologic therapy. The maintenance doses are the same as those in the GALAXI studies. The study employed a treat-through design, with participants remaining on their assigned regimen regardless of clinical response at the end of induction.

Participants randomized to placebo could receive guselkumab if rescue criteria were met at week 16. The GALAXI program (NCT03466411) is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program evaluating guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response to conventional therapies.

GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two Phase 3 studies (GALAXI 2 and 3). Each study employed a treat-through design with a long-term extension to assess clinical, endoscopic, and safety outcomes through five years. Participants randomized to placebo could receive ustekinumab if clinical response was not met at week 12.

Crohn’s Disease

Crohn’s Disease Affects Millions as Johnson & Johnson’s TREMFYA® Shows Promise

Crohn’s disease is one of the two main forms of inflammatory bowel disease, affecting approximately three million Americans and around four million people across Europe. It is a chronic inflammatory condition of the gastrointestinal tract with no known cause but is associated with abnormalities in the immune system. These could be triggered by genetic predisposition, diet, or environmental factors. Symptoms include abdominal pain, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently, there is no cure for Crohn’s disease.

Developed by Johnson & Johnson, TREMFYA® is the first fully human monoclonal antibody that blocks IL-23 by binding to its p19 subunit and CD64, a receptor on cells that produce IL-23. IL-23 is a crucial driver of inflammatory diseases. TREMFYA® is approved in the U.S., Canada, Japan, and several other countries for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis. It is also approved in the EU for the same indications. Johnson & Johnson holds exclusive worldwide marketing rights to TREMFYA®.

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TREMFYA® is a prescription medicine that may cause serious side effects, including severe allergic reactions and infections. It may lower the immune system’s ability to fight infections, increasing the risk of tuberculosis (TB) and other infections. Patients should be checked for TB before starting treatment and monitored during and after treatment. If signs of an infection appear, patients should contact their healthcare provider immediately.

 

Resource: Johnson & Johnson, June 20, 2024

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