Johnson & Johnson announced data from the Phase 3 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 U.S. Food and Drug Administration (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.^a "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:

• Clinical remission (27.6% vs 6.5%; P<0.001) ^b
• Clinical response (65.6% vs 34.5%; P<0.001) ^c
• Endoscopic improvement (37.3% vs 12.9%; P<0.001) ^d

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.