SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) revealed encouraging topline results from its Phase 3 GRAVITI study on TREMFYA® (guselkumab) subcutaneous (SC) induction therapy for adults with moderate to severe Crohn’s disease. The study achieved significant outcomes for clinical remission and endoscopic response at Week 12.
The trial met both of its co-primary endpoints, showing statistically significant and clinically meaningful improvements compared to a placebo. These positive results extended to all remaining controlled endpoints at Weeks 12, 24, and 48.
The GRAVITI study builds on the successful outcomes seen in the GALAXI 2 and GALAXI 3 trials. These were the first double-blind, head-to-head registrational clinical trials to demonstrate TREMFYA’s superiority over STELARA® (ustekinumab) in key endoscopic measures for Crohn’s disease. Combined, these studies highlight TREMFYA’s potential as the only IL-23 inhibitor offering both subcutaneous and intravenous induction options.
“The Phase 3 GRAVITI study showed promising results with SC induction and provides similar clinical benefit to what was seen with IV induction in the GALAXI studies,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology at Johnson & Johnson Innovative Medicine. He added that having both SC and IV induction options enhances treatment flexibility for patients and healthcare providers.
Safety data from the GRAVITI study were consistent with TREMFYA’s known safety profile in other approved uses.
Johnson & Johnson plans to present the GRAVITI results at upcoming medical conferences and will share the findings with health authorities in future submissions. Additionally, the company is conducting a separate study to evaluate the efficacy and safety of TREMFYA SC induction therapy for ulcerative colitis.
TREMFYA’s success in these trials positions it as a strong contender in the treatment of Crohn’s disease, offering new hope and more options for patients and physicians alike.
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