Tremfya (Guselkumab) Dual Induction Therapy in UC

Johnson & Johnson announced data from the Phase III ASTRO study of Tremfya (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO). Study findings through Week 12 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 in this population.

“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 Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (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.”

At Week 12, significantly greater proportions of patients treated with Tremfya 400 mg SC induction compared with patients receiving placebo achieved all of the following multiplicity-controlled endpoints: i) Clinical remission (27.6% vs 6.5%; P<0.001); ii) Clinical response (65.6% vs 34.5%; P<0.001); iii) Endoscopic improvement (37.3% vs 12.9%; P<0.001)

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. The proportions of patients with ≥1 adverse event (AE), serious AE, or AE leading to treatment discontinuation were similar across the Tremfya and placebo treatment groups.

“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. These results further underscore the potential of Tremfya to transform the UC treatment paradigm,” said Esi Lamousé-Smith, M.D., Ph.D., 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.”

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 (see above) which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.