TREMFYA® (guselkumab) shows promise as the sole IL-23 inhibitor for subcutaneous and intravenous induction

Johnson & Johnson has declared promising results from their Phase 3 GRAVITI trial, which investigated the effectiveness of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderate to severe Crohn's disease. This pivotal study hit all its primary and secondary endpoints, showing significant clinical remission and endoscopic response at the 12-week mark. Additionally, all secondary endpoints at Weeks 12, 24, and 48 were statistically significant when compared to placebo.

Dr. David Lee, the Global Therapeutic Area Head of Immunology at Johnson & Johnson Innovative Medicine, explained that the GRAVITI study's findings for SC induction were comparable to those seen with intravenous (IV) induction in earlier GALAXI studies. The availability of both SC and IV induction options for TREMFYA® means that patients and healthcare providers now have more flexibility. TREMFYA® is expected to be the first IL-23 inhibitor offering a comprehensive SC therapy for both induction and maintenance in Crohn's disease.

The GRAVITI study's results will soon be presented at medical conferences and shared with health authorities as part of planned submissions. Johnson & Johnson is also conducting a separate study to evaluate the SC induction therapy of TREMFYA® in ulcerative colitis.

The GRAVITI trial (NCT05197049) is a randomized, double-blind, placebo-controlled Phase 3 study. It evaluated the efficacy of guselkumab SC induction therapy at doses of 400 mg administered at Weeks 0, 4, and 8 in patients with inadequate response or intolerance to conventional or biologic therapies. The maintenance doses in GRAVITI matched those used in previous GALAXI trials (200 mg SC every 4 weeks and 100 mg SC every 8 weeks).

The GALAXI program is another extensive study series aimed at assessing the safety and efficacy of guselkumab in Crohn's disease. It includes a Phase 2 dose-ranging study (GALAXI 1) and two Phase 3 studies (GALAXI 2 and 3). These trials employed a treat-through design, with participants remaining on their assigned treatment throughout the study. The program also features a long-term extension to evaluate clinical, endoscopic, and safety outcomes over five years.

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract affecting millions of people in the U.S. and Europe. The disease is associated with immune system abnormalities, potentially triggered by genetic factors, diet, or environmental influences. Symptoms typically include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is currently no cure for Crohn's disease.

TREMFYA® (guselkumab) is a fully-human monoclonal antibody developed by Johnson & Johnson that inhibits IL-23 by binding to its p19 subunit. It is currently approved in several countries for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults.

TREMFYA® has shown a consistent safety profile across multiple studies. However, it may cause serious side effects, including allergic reactions and infections, and potentially lowers the immune system's ability to combat infections. Patients should undergo screening for tuberculosis before starting treatment and be monitored for any signs of infection during and after the treatment.

Comparatively, STELARA® (ustekinumab) is another treatment from Johnson & Johnson that targets IL-12 and IL-23. It is used for treating conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. STELARA® also carries risks of serious infections and other side effects, such as lung inflammation and allergic reactions.

In summary, Johnson & Johnson's recent findings underline the potential of TREMFYA® as a versatile and effective treatment for Crohn's disease, offering both SC and IV induction options to better serve patient needs. The continued research and development efforts highlight the company's commitment to advancing treatments for chronic inflammatory diseases.