Tremfya (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis – Johnson & Johnson

Johnson & Johnson announced new 48-week data from the Phase III ASTRO study evaluating Tremfya (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). These data show clinically meaningful rates of clinical and endoscopic remission, making Tremfya the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. The findings are among 20 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2025.

Tremfya is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.

The ASTRO Week 48 data build on the previously reported Week 12 SC induction data, which showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures. Data through Week 48 show patients treated with Tremfya 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo (all nominal p<0.001).Furthermore, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, Tremfya demonstrated clinically meaningful results across all endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients. Safety data from the ASTRO study were consistent with the well-established safety profile of Tremfya.

“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, IRCCS Ospedale San Raffaele and University VitaSalute San Raffaele in Milan, Italy and study investigator. “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.”

“These results reflect our unwavering commitment to advancing the science that delivers both meaningful outcomes and more choices for healthcare providers and their patients,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Tremfya is the only IL-23 inhibitor to offer a subcutaneous induction option in both Crohn’s disease and ulcerative colitis, the latter of which was recently approved by the U.S. FDA and supported by findings from the ASTRO study.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.”

ABOUT THE ASTRO STUDY ( NCT05528510)
ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase III study designed to evaluate the efficacy and safety of Tremfya SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive Tremfya 400 mg SC induction at Weeks 0, 4 and 8 followed by Tremfya 200 mg SC every 4 weeks (q4w); or Tremfya 400 mg SC induction at Weeks 0, 4 and 8, followed by Tremfya 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase III QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.