FDA Approves Guselkumab for Treatment of Ulcerative Colitis
Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.
The FDA approved guselkumab (Tremfya; Johnson & Johnson) for the treatment of moderate-to-severe ulcerative colitis. Guselkumab is the first and only approved fully human and dual-acting monoclonal antibody, which works by blocking interleukin (IL)-23 and binding to CD64 receptors.1
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“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,” David T. Rubin, MD, director of Inflammatory Bowel Disease Center at the University of Chicago Medicine, said in a news 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.”1
The approval is based on data from the ongoing phase 2b/3 QUASAR study (NCT04033445), showing that 50% of individual receiving the 200 mg maintenance therapy every 4 weeks and 45% of those receiving the 100 mg therapy had clinical remission at week 44 compared with only 19% of patients on the placebo. Furthermore, 34% and 35% of individuals achieved endoscopic remission at 1 year, respectively, compared with 15% of patients on the placebo.1
As part of the study, investigators included 3 parts: a phase 2b dose-ranging induction study, a phase 3 induction study, and a phase 3 randomized withdrawal maintenance study. The 2b induction study was conducted between September 2019 and February 2022, including individuals from 141 centers across 25 countries and territories, according to the study authors. The primary objective was evaluating the efficacy and safety of the drug for patients. Dose response was also evaluated.2
Investigators included individuals who did not respond well to conventional therapy, previous biologics, and/or Janus kinase inhibitors. The data showed that there were significant improvements in symptoms, patient-reported outcomes, and measures of disease activity as well as positive changes in fatigue and endoscopic and histologic remission.3
In March, Johnson & Johnson announced the submission of the supplemental biologics license application for the drug as treatment of ulcerative colitis. It initially received FDA approval in July 2017 for moderate-to-severe plaque psoriasis and July 2020 for psoriatic arthritis.3
As for safety, the results were consistent with the approved safety profile, including adverse effects such as upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, fungal skin infections, herpes simplex infections, and bronchitis.3
“There is a significant need for new [ulcerative colitis] 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,” Christopher Gasink, MD, vice president of Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine, said in the news 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.”1
