FDA Approves Tremfya for Moderately to Severely Active Ulcerative Colitis

Image Credit: Adobe Stock Images/Elkhan Babayev

The FDA has approved Johnson & Johnson’s (J&J) Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). According to the company, this marks the first and only fully-human, dual-acting monoclonal antibody targeting interleukin (IL)-23 and CD64 to be approved by the FDA.¹

“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, Inflammatory Bowel Disease Center, University of Chicago Medicine, lead investigator, QUASAR program, in a press release. “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.”

The regulatory action was based on positive results from the ongoing randomized, double-blind, placebo-controlled, parallel group, multicenter Phase II/III QUASAR trial, which evaluated the efficiacy and safety of Tremfya in UC patients who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or Janus kinase inhibitors. The primary endpoint of the study was clinical remission at week 44. The trial included a Phase IIb dose-ranging induction portion, a confirmatory Phase III induction portion, and a Phase III maintenance portion. J&J stated that efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers were assessed at specified time points.

Tremfya demonstrated significant clinical and endoscopic improvements in patients with inadequate responses or intolerance to conventional therapies. Fifty-percent of patients administered 200 mg and 45% administered 100 mg of Tremfya achieved clinical remission by week 44, compared to 19% in the placebo group. Further, endoscopic remission was achieved in 34% of patients in the 100 mg group and 35% of patients in the 200 mg group, while only 15% in the placebo group achieved endoscopic remission.

Common adverse events (AEs) included respiratory tract infections, injection site reactions, and arthralgia. AEs were more common in patients administered Tremfya compared with those administered a placebo.

Tremfya is to be administered at 200 mg intravenously at weeks zero, four, and eight by a healthcare professional. Tremfya as a maintenance therapy is recommended be taken at 100 mg subcutaneous (SC) injection at week 16, and every eight weeks afterwards or 200 mg administered by SC injection at week 12, and every four weeks thereafter.¹

According to the National Institutes of Health, anywhere from 600,000 to 900,000 people in the United States are currently living with UC. It is most common in people between the ages of 15 and 30 years of age, but can develop in people of any age group. Additionally, it is more common in families with a history of UC and those with Jewish heritage. UC can increase the chances of a patients eventually being diagnosed with colorectal cancer.²

“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, VP, medical affairs, gastroenterology & autoantibody, J&J Innovative Medicine, in a press release. “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.”

References

1. TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. J&J. September 11, 2024. Accessed September 12, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease

2. Definition & Facts of Ulcerative Colitis. NIH. Accessed September 12, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts#:~:text=How%20common%20is%20ulcerative%20colitis,United%20States%20have%20ulcerative%20colitis.