The US Food and Drug Administration has officially approved Johnson & Johnson’s TREMFYA® therapeutic for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed. According to certain reports, this development makes TREMFYA® the first and only approved fully-human, dual-acting monoclonal antibody which can block IL-23 while also binding to CD64, a receptor on cells capable of producing IL-23. To offer some context, IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells, also known to be a driver of immune-mediated diseases including UC. Anyway, Johnson & Johnson markedly achieved the stated approval thanks to data provided by a pivotal, ongoing Phase 2b/3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adult patients. More on the study’s participating population would reveal that it included patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics, and/or JAK inhibitors. All in all, QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 2b/3 program, a program which included one Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study.
As for the results, they showed how nearly 50% of patients receiving TREMFYA® 200 mg subcutaneous (SC) maintenance every four weeks (q4w), and 45% of patients receiving TREMFYA® 100 mg SC every eight weeks (q8w), achieved primary endpoint of clinical remission at week 44, compared to 19% placebo-treated patients. Beyond that, the study also saw 34% of patients (200mg) and 35% (100mg) achieving endoscopic remission at one year with TREMFYA® SC maintenance therapy, as compared to 15% placebo-treated patients.
“Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining,” said David T. Rubin, MD, Director of Inflammatory Bowel Disease Center at the University of Chicago Medicine, and lead investigator for the QUASAR program. “Today’s approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.”
Talk about how TREMFYA® is to be used for the treatment of UC, the therapeutic must be administered as a 200 mg induction dose intravenously at weeks zero, four, and eight by a healthcare professional. Furthermore, the recommended maintenance dosage is understood to be 100 mg administered by SC injection at week 16, and every 8 weeks from that point, or 200 mg administered by SC injection at week 12, and every 4 weeks from then on.
Now, while the approval makes for a significant milestone, it is actually the third indication approved for TREMFYA. You see, the therapeutic landed its first regulatory nod in the US during July 2017, and it did so for the treatment of adult patients with moderate-to-severe plaque psoriasis. It would receive a subsequent approval for use in adults with active psoriatic arthritis during July 2020. In June 2024, Johnson & Johnson would also submit a supplemental Biologics License Application (sBLA) to the FDA for using TREMFYA® in adult patients with moderately to severely active Crohn’s disease.
“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,” said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine. “In the QUASAR clinical program, 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 inflammatory bowel disease.”
