SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) released new 48-week results from its Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) as a subcutaneous induction and maintenance therapy for adults with moderately to severely active ulcerative colitis (UC). The data showed durable clinical and endoscopic remission, reinforcing TREMFYA® as the first and only IL-23 inhibitor to demonstrate robust, long-term outcomes with a fully subcutaneous regimen.
In the study, 36.7% of patients achieved clinical remission and 25.9% reached endoscopic remission at Week 48 following treatment with subcutaneous TREMFYA®. The results were consistent across both biologic-naïve and biologic-refractory subgroups, underscoring the therapy’s potential to serve a broad range of UC patients.
TREMFYA® is the first dual-acting monoclonal antibody to block IL-23 while also binding to CD64, a receptor found on cells that produce IL-23, a cytokine known to drive immune-mediated inflammatory diseases. The therapy’s dual mechanism and flexible delivery options—both intravenous and subcutaneous—reflect Johnson & Johnson’s continued expansion in the IL-23 therapeutic space.
The latest results build on earlier 12-week findings that showed significant improvement across clinical and endoscopic measures. At 48 weeks, patients who received TREMFYA® 400 mg subcutaneous induction followed by maintenance dosing of either 100 mg every eight weeks or 200 mg every four weeks sustained statistically significant benefits versus placebo (all nominal p<0.001).
Safety outcomes were consistent with TREMFYA®’s established profile, with no new safety signals reported.
“For many patients, having a subcutaneous induction option is an important step forward—offering the flexibility of at-home administration after proper training without compromising efficacy,” said Prof. Silvio Danese of IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele in Milan, Italy. “These results show that a fully subcutaneous regimen of guselkumab can deliver meaningful clinical and endoscopic benefits that are sustained for a full year, supporting long-term disease control in ulcerative colitis.”
Esi Lamousé-Smith, M.D., Ph.D., Vice President and Gastroenterology Disease Area Lead for Johnson & Johnson Innovative Medicine, said the results reflect the company’s ongoing investment in patient-centered innovation. “TREMFYA is the only IL-23 inhibitor to offer a subcutaneous induction option in both Crohn’s disease and ulcerative colitis,” she noted. “This latest development offers patients and providers the choice of starting treatment for UC with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction.”
TREMFYA® has received U.S. Food and Drug Administration and European Commission approvals for both intravenous and subcutaneous induction in Crohn’s disease. In ulcerative colitis, the therapy recently gained U.S. approval for subcutaneous induction and remains approved in Europe for intravenous induction followed by subcutaneous maintenance.
With these results, Johnson & Johnson continues to strengthen its position in gastroenterology, advancing treatment options for immune-mediated conditions with therapies designed for sustained efficacy, safety, and patient convenience.
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