Johnson & Johnson Reports Positive Phase 3 ASTRO Study Data For TREMFYA In Ulcerative Colitis

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(RTTNews) - Drug major Johnson & Johnson (JNJ) announced Monday positive new data from the Phase 3 ASTRO study evaluating TREMFYA (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis or UC.

The company noted that TREMFYA is positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks.

Johnson & Johnson said the data at Week 24 show patients treated with TREMFYA 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks or 200 mg every four weeks demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.

TREMFYA is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. These findings are among 24 abstracts highlighting the company's research being presented at Digestive Disease Week or DDW 2025.

Furthermore, at Week 24, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients.

According to the firm, safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA.

The ASTRO Week 24 data build on the Week 12 SC induction data that showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration-approved intravenous (IV) induction regimen evaluated in this population, in the Phase 3 QUASAR study.

Millie Long, Professor of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and study investigator, said, "Data from the ASTRO study demonstrate that subcutaneous induction treatment with TREMFYA provides clinically meaningful remission in patients with ulcerative colitis, similar to the effects seen with intravenous induction. The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach."

TREMFYA received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen.

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