Johnson & Johnson’s (J&J) dual-acting IL-23 inhibitor Tremfya (guselkumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active ulcerative colitis (UC).
Estimated to affect more than one million people in the US, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.
Patients can experience a range of unpredictable symptoms, including loose and more frequent bowel movements, bloody stools, abdominal pain and loss of appetite.
Already authorised to treat certain cases of plaque psoriasis and active psoriatic arthritis, Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor.
For the treatment of UC, the drug is administered as a 200mg induction dose intravenously at weeks zero, four and eight, followed by a subcutaneous (SC) maintenance dose of either 100mg at week 16 and then every eight weeks, or 200mg at week 12 and every four weeks thereafter.
The approval was supported by positive data from the ongoing phase 2b/3 QUASAR study, which has been evaluating the drug in adults with moderately to severely active UC who experienced an inadequate response or demonstrated intolerance to conventional therapy, other biologics and/or JAK inhibitors.
Results showed that 50% of patients receiving a 200mg SC maintenance dose of Tremfya every four weeks and 45% of patients receiving Tremfya 100mg SC every eight weeks achieved the primary endpoint of clinical remission at week 44 compared to 19% placebo-treated patients.
Additionally, 34% and 35% of patients receiving Tremfya 200mg and 100mg, respectively, achieved endoscopic remission at one year with compared to 15% of those in the placebo cohort.
Christopher Gasink, vice president, medical affairs, gastroenterology and autoantibody, J&J Innovative Medicine, said: “There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission.
“In the QUASAR clinical programme, Tremfya demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this IBD.”