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Johnson & Johnson (NYSE:JNJ) today 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.1
"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
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.
"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."
TREMFYA® is the first and only approved fully-human, 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.1,2,3,4,5
Applications seeking approval of TREMFYA® for both UC and Crohn’s disease (CD) have been submitted in
For a full list of all data being presented at ECCO visit: https://innovativemedicine.jnj.com/our-innovation/focus-areas/immunology/gastroenterology/gastroenterology-newsroom
Editor’s Notes:
a.
b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0, or 1 with no friability present on the endoscopy.
c. Clinical response was defined as a decrease from induction baseline in the modified Mayo score by ≥30 percent and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
d. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
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