Johnson & Johnson (J&J) has shared positive long-term results from a phase 3 trial of its dual-acting IL-23 inhibitor Tremfya (guselkumab) in patients with ulcerative colitis (UC).
The QUASAR long-term extension study has been evaluating the drug in adults with moderately to severely active UC who have had an inadequate response, or been intolerant, to conventional therapy, prior biologics and/or Janus kinase (JAK) inhibitors.
Results presented at this year’s Digestive Disease Week (DDW) showed that 72% of patients were in clinical remission at week 92, with 99% of these patients remaining corticosteroid free for eight or more weeks.
Endoscopic remission was achieved by 43% of patients at week 92 and, among those achieving endoscopic improvement at week 44, 84% maintained endoscopic improvement to week 92.
These benefits were seen in patients regardless of prior biologic and/or JAK inhibitor treatment history, J&J said, adding that safety data from the trial was “consistent with the well-established safety profile of Tremfya in inflammatory bowel disease (IBD)”.
More than 2.5 million people in Europe are affected by UC, one of the two main forms of IBD. 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 received approval from the European Commission last month to treat adults with moderately to severely active UC. The drug is also approved in the US for the same indication.
Esi Lamousé-Smith, vice president, gastroenterology disease area lead, immunology, J&J Innovative Medicine, added: “With these findings, Tremfya shows the powerful impact it can have in achieving longer term remission in patients.”
Alongside data from QUASAR, J&J presented at DDW positive new results from the phase 3 ASTRO study of Tremfya subcutaneous (SC) induction therapy in adults with moderately to severely active UC.
For the treatment of UC, the drug is currently administered via an intravenous (IV) induction regimen, followed by a SC maintenance regimen. It is hoped that SC and IV induction options would give patients and healthcare professionals greater flexibility.