Clinical Trials

The trial demonstrated that 50% of those subcutaneously (SC) treated with 200mg Tremfya every four weeks and 45.2% of those treated with SC Tremfya 100mg every eight weeks achieved the primary endpoint of clinical remission at 44 weeks of treatment, compared to 18.9% in the placebo group.

Of these patients in clinical remission, 67% and 71%, respectively, were also in endoscopic remission at the 44 week mark, which indicates that they had a normal appearance of intestinal mucosa.

Both treatment groups also met all nine secondary endpoints.

David Lee MD PhD, global therapeutic area head of Immunology at J&J, commented: “The phase 3 QUASAR Maintenance Study continues to demonstrate the promise of Tremfya to unlock potential treatment options for patients living with UC who continue to experience debilitating symptoms despite the availability of treatments today. These findings underscore our commitment to elevate the standard of care in UC and strengthen our resolve to advance inflammatory bowel disease science.”

David T Rubin MD, chief of the Section of Gastroenterology, Hepatology and Nutrition, University of Chicago, US, and lead study investigator, added: “These data suggest the potential of guselkumab to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalisation and histologic remission, which represent the kind of progress needed in new treatments for this inflammatory bowel disease. The clinical results measured at Week 44 in the QUASAR Maintenance Study suggest that treatment with guselkumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that impact their daily lives.”