TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

Key Findings from the GRAVITI Study - The Phase 3 GRAVITI study of TREMFYA® (guselkumab) achieved all primary and secondary endpoints, demonstrating statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12 in adult patients with moderately to severely active Crohn's disease [1] - The study also showed significant results for secondary endpoints at Weeks 24 and 48 compared to placebo, reinforcing the potential of TREMFYA® as a treatment option for Crohn's disease [1] - TREMFYA® is positioned to be the only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, providing versatility for patients and healthcare providers [1] About the GRAVITI and GALAXI Programs - The GRAVITI program 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 Crohn's disease who had inadequate response to conventional or biologic therapies [3] - The GALAXI program includes Phase 2 and Phase 3 studies (GALAXI 1, 2, and 3) designed to evaluate the efficacy and safety of guselkumab in Crohn's disease patients, with long-term extension studies assessing outcomes over five years [4] About Crohn's Disease - Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract affecting approximately 3 million Americans and 4 million Europeans, with symptoms including abdominal pain, diarrhea, and weight loss [5][6] - The disease has no known cure and is associated with immune system abnormalities potentially triggered by genetic, dietary, or environmental factors [5][6] About TREMFYA® (guselkumab) - TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to its p19 subunit and CD64, a receptor on IL-23-producing cells [7] - It is approved in multiple countries for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis, with ongoing studies for ulcerative colitis and Crohn's disease [7] About STELARA® (ustekinumab) - STELARA® is an IL-12 and IL-23 antagonist approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in the United States [13] - It is marketed exclusively by the Janssen Pharmaceutical Companies of Johnson & Johnson [13] About Johnson & Johnson - Johnson & Johnson focuses on healthcare innovation, aiming to prevent, treat, and cure complex diseases through its expertise in Innovative Medicine and MedTech [25] - The company is committed to delivering personalized healthcare solutions and driving breakthroughs in the industry [25]