Johnson & Johnson (J&J) has shared positive results from a late-stage study evaluating a subcutaneous (SC) version of Tremfya (guselkumab) in ulcerative colitis (UC).
The phase 3 ASTRO trial has been investigating the use of Tremfya SC induction therapy in adults with moderately to severely active cases of the disease.
Results presented at this year’s Congress of the European Crohn’s and Colitis Organization showed that SC Tremfya 400mg induction led to statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures at week 12.
Clinical remission was achieved by 27.6% of SC Tremfya-treated patients versus 6.5% in the placebo group at week 12, while 65.6% of those in the SC Tremfya cohort had a clinical response compared to 34.5% in the placebo arm.
Endoscopic improvement was also achieved by 37.3% of patients being treated with SC Tremfya compared to 12.9% of those randomised to receive placebo.
UC is one of the two main forms of inflammatory bowel disease (IBD), which affects almost one in every 100 people in the US.
Patients can experience a range of unpredictable symptoms, including loose and more frequent bowel movements, bloody stools, abdominal pain and loss of appetite.
Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and was approved by the US Food and Drug Administration (FDA) in September to treat adults with moderately to severely active UC, administered via an IV induction regimen, followed by a SC maintenance regimen.
It is hoped that a fully SC treatment regimen would offer increased flexility to patients.
Esi Lamousé-Smith, vice president, gastroenterology disease area lead, immunology, J&J Innovative Medicine, said: “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.”
J&J has already submitted an application to the FDA for the Tremfya SC induction regimen in moderately to severely active UC.
Lamousé-Smith said that, if approved, “Tremfya would be the first IL-23 inhibitor with a fully SC induction and maintenance regimen, increasing options for both patients and healthcare providers”.