Tremfya (guselkumab) 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

Johnson & Johnson announced new data from the Phase III ASTRO study evaluating Tremfya (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). 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 FDA-approved intravenous (IV) induction regimen evaluated in this population, in the Phase III QUASAR study. Tremfya is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen.

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 (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.

“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,” said Millie Long, M.D., MPH, Professor of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and study investigator. “The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach.”

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. Safety data from the ASTRO study were consistent with the well-established safety profile of Tremfya.

“These results highlight the potential of Tremfya to redefine ulcerative colitis care with a fully subcutaneous induction and maintenance regimen that offers a convenient option with meaningful clinical and endoscopic improvements,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “Our goal is to reshape UC care and empower prescribers with a differentiated and effective treatment that offers the option of patient self-administration from day one.”

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 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.