SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced positive results from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The study achieved its primary and all secondary endpoints at Week 12, demonstrating statistically significant and clinically meaningful improvements compared to placebo. These findings align with the efficacy of the FDA-approved intravenous (IV) induction regimen currently in use.
Administering TREMFYA® 400 mg as SC induction therapy resulted in the following outcomes by Week 12 compared to placebo:
- Clinical remission rates of 27.6% versus 6.5% (P<0.001)
- Clinical response rates of 65.6% versus 34.5% (P<0.001)
- Endoscopic improvement rates of 37.3% versus 12.9% (P<0.001)
Key subpopulation analyses revealed significant improvements across biologic and JAK inhibitor-naïve as well as refractory patients, further underscoring TREMFYA’s broad efficacy.
“The Week 12 results from the ASTRO study build on data from the QUASAR study demonstrating that both guselkumab SC and IV induction achieved clinically differentiated results in patients with moderately to severely active UC,” said Dr. Laurent Peyrin-Biroulet, Head of the IBD Unit at Nancy University Hospital in France and study investigator. “The flexibility of a fully SC treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles.”
Safety data from the study reinforced the established safety profile of TREMFYA®, showing a comparable rate of adverse events (AEs), serious AEs, and discontinuations between the SC treatment group and those on placebo.
TREMFYA®, the first dual-acting monoclonal antibody to target IL-23 while binding to CD64, has been recognized for its innovative mechanism addressing immune-mediated conditions like UC. The drug is currently FDA-approved for UC treatment through an IV induction regimen followed by SC maintenance. Pending approval of its SC induction therapy, TREMFYA® stands to become the first IL-23 inhibitor providing a fully SC treatment option.
“We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life,” said Dr. Esi Lamousé-Smith, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Pending approval, TREMFYA would be the first IL-23 inhibitor with a fully SC induction and maintenance regimen, increasing options for both patients and healthcare providers.”
With applications submitted for approval in Europe and an sBLA under review in the U.S., TREMFYA® is poised to advance the UC treatment landscape. The promising results from the ASTRO study underscore its potential to transform care for UC patients by offering an effective, flexible, and convenient therapeutic option.
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