The Future of Ulcerative Colitis Treatment: Tremfya's Potential Unveiled

Exciting news in medical advancements as Johnson & Johnson's (J&J) groundbreaking drug, Tremfya (guselkumab), showed promising results in a recent Phase III trial for ulcerative colitis.

The findings of the Phase III QUASAR maintenance study were presented at the American Gastroenterological Association's Digestive Disease Week meeting in May by David T. Rubin M.D., Professor of Medicine and Chief of the Section of Gastroenterology, Hepatology and Nutrition at The University of Chicago Medicine, revealed that Tremfya successfully achieved primary and secondary endpoints in patients with ulcerative colitis.

Ulcerative colitis is a chronic illness that affects millions worldwide, causing inflammation and ulcers in the digestive tract, leading to debilitating symptoms. Finding an effective treatment has been a long journey for patients and healthcare providers.

Tremfya is an interleukin (IL)-23 and CD64-inhibiting monoclonal antibody.

The FDA approved it in 2017 as a moderate to severe plaque psoriasis treatment. It has since been approved to treat psoriatic arthritis.

Participants in the trial were randomized to receive either a placebo or one of two doses of Tremfya: 200mg every four weeks or 100mg every eight weeks. Individuals included in the study had to have a documented diagnosis of moderate to severely active ulcerative colitis and demonstrate an inadequate response or intolerance to prior therapies.

The study's maintenance therapy data showed that 45% of patients achieved clinical remission, the primary endpoint, after 44 weeks of treatment. Close to 70% achieved endoscopic remission, indicating no signs of inflammation, ulcers, or bleeding in the bowel.

The high rates of clinical responses observed in participants treated every four or eight weeks support the clinical remission results. Response rates over 70% were achieved in both treatment groups compared to a 43% response rate in the placebo group. Endoscopic improvement, defined as histo-endoscopic mucosal healing and histologic grading, occurred in roughly 50% of the treated groups compared to 19% in the placebo group.

J&J’s Tremfya is expected to be a potential successor to their current therapy, Stelara, an IL-12/IL-23 inhibitor, for treating conditions such as severe plaque psoriasis, active psoriatic arthritis and ulcerative colitis. Stelara faces biosimilar competition as new entrants are expected to launch in 2025.

Tremfya's success in the Phase III trial adds to its growing potential in the market and highlights its effectiveness in addressing inflammatory bowel diseases. J&J is also evaluating Tremfya as a potential treatment for Crohn's disease in a Phase II trial.

“The phase 3 maintenance results of guselkumab in moderate-to-severe ulcerative colitis demonstrate the long-term efficacy and excellent safety profile of this treatment in this population. Of particular interest are the excellent mucosal healing results and the potential that the proposed dual mechanism of action of this therapy- inhibiting IL23 and the CD64 target as the site of IL23 production may offer unique benefits for our patients,” Rubin says.

The FDA approval for using Tremfya to treat ulcerative colitis is pending and is expected to be granted later this year or early next year.