Johnson & Johnson has released new 96-week data from the long-term extension phases of its Phase 3 GRAVITI, GALAXI 2, and GALAXI 3 trials. The findings highlight the sustained effectiveness of TREMFYA in adults living with moderate to severe Crohn’s disease over a two-year period. These results are among 23 company abstracts presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG).
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TREMFYA is the first and only approved monoclonal antibody that both blocks interleukin 23 (IL-23) and binds to CD64, a receptor present on immune cells that produce IL-23. This cytokine, secreted by activated macrophages and dendritic cells, is a known driver of several immune-mediated inflammatory diseases, including ulcerative colitis. The mechanism was established through laboratory research.
After 96 weeks of treatment, patients who received TREMFYA through either 400 mg subcutaneous induction or 200 mg intravenous induction, followed by subcutaneous maintenance dosing of 100 mg every eight weeks or 200 mg every four weeks, demonstrated high rates of clinical remission, endoscopic response, endoscopic remission, and deep remission.
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Participants included in this analysis were those who continued treatment during the extension phase and had data available at Week 96. Safety outcomes through the same period were consistent with TREMFYA’s previously known safety profile, showing no new risks.
Dr. David Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago, explained that Crohn’s disease significantly affects daily life and long-term health. He noted that the latest findings show guselkumab can achieve endoscopic remission with either subcutaneous or intravenous induction, offering patients more flexibility and confidence in managing their condition.
The GRAVITI trial compared subcutaneous TREMFYA induction and maintenance to placebo, while the GALAXI 2 and 3 trials evaluated intravenous induction followed by subcutaneous maintenance against placebo and STELARA. Previous pooled data from the GALAXI program showed TREMFYA outperformed STELARA across all endoscopic endpoints at Week 48, making it the only IL-23 inhibitor to achieve this in a double-blind registrational study.
Esi Lamousé-Smith, MD, PhD, Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson Innovative Medicine, said the data confirm the company’s dedication to improving options for people with inflammatory bowel disease. She emphasized that TREMFYA, now approved for both subcutaneous and intravenous induction in Crohn’s disease as well as ulcerative colitis, offers patients meaningful choices and lasting benefits.
TREMFYA has received FDA approval for treating adults with moderate to severe active Crohn’s disease and ulcerative colitis, available in both intravenous and subcutaneous induction forms, giving patients and clinicians greater flexibility in their treatment plans.
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