Johnson & Johnson has 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 Organisation (ECCO).
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Study findings through Week 12 showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures.
“The Week 12 results from the ASTRO study build on data from the QUASAR study demonstrating that both guselkumab subcutaneous and intravenous 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 subcutaneous 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 guselkumab 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, guselkumab demonstrated statistically significant results across endpoints in both naïve and experienced biologic, Janus kinase inhibitor, and/or sphingosine 1-phosphate inhibitor patients. Safety data from the ASTRO study were consistent with the established safety profile of guselkumab. The proportions of patients with ≥1 adverse event (AE) (39.4% of guselkumab-treated patients vs 52.5% with placebo), serious AE (2.5% of guselkumab-treated patients vs 7.9% with placebo), or AE leading to treatment discontinuation (1.1% of guselkumab-treated patients vs 5.8% with placebo) were similar across the guselkumab 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 guselkumab 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, guselkumab would be the first IL-23 inhibitor with a fully subcutaneous induction and maintenance regimen, increasing options for both patients and healthcare providers.”
“The findings from the ASTRO study highlight guselkumab’s potential to bring meaningful improvements to the lives of individuals with UC,” stated Mark Graham, senior director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. “Subcutaneous induction therapy with guselkumab could help empower people living with UC to actively manage their symptoms while providing choice and simplicity for both patients and their healthcare providers.”
Johnson & Johnson has submitted regulatory applications seeking the approval of guselkumab for the treatment of adults with moderately to severely active Crohn’s disease (CD) & UC in Europe.