2 new therapies can treat ulcerative colitis
- Two new therapies have been identified as promising treatments for ulcerative colitis, a chronic inflammatory disease of the large intestine.
- A global study published in The New England Journal of Medicine found that a drug called tulisokibart was effective in treating moderate to severe ulcerative colitis, with 26% of participants achieving clinical remission compared to 1% on placebo.
- Another study published in The Lancet evaluated the efficacy and safety of guselkumab, a monoclonal antibody that targets IL-23, and found that it significantly improved clinical remission (23%) and maintained remission at 44 weeks (50%) compared to placebo.
- The FDA has approved the use of Tremfya, the brand name for guselkumab, to treat moderately to severely active ulcerative colitis, marking a significant advancement in treatment options for patients with the disease.
- Researchers are also exploring the potential of microbiome-based tests that can diagnose inflammatory bowel disease (IBD) using fecal samples from patients, which could lead to earlier intervention and improved patient outcomes.
Researchers have identified promising new treatments for ulcerative colitis.
According to the National Institutes of Health, between 600,000 and 900,000 Americans have ulcerative colitis, a chronic inflammatory disease of the large intestine.
While treatments for the disease exist, not all patients respond to them. The results of two global studies—one published in The New England Journal of Medicine and another in The Lancet—offer hope to these individuals in the form of two new treatments.
“For quite a while, our field has had a ‘therapeutic ceiling’ where only a percentage of patients respond to available treatments, achieve remission, and sustain control,” says David T. Rubin, a professor of medicine at the University of Chicago and an author on both papers.
“These studies describe the successful results of two new therapies that were effective in treating moderate to severe ulcerative colitis.”
The New England Journal of Medicine paper explored the use of a drug called tulisokibart as both a treatment for the disease and a companion diagnostic to determine response to the treatment. The drug works by targeting TL1A, the product of a gene expressed in many different inflammatory cells.
The double-blind study involved two groups of patients. The first consisted of 135 adults with moderate to severe ulcerative colitis who had not responded to currently available treatments. Participants were randomly assigned tulisokibart or a placebo and followed over a 12-week period. The study found that a significantly higher percentage of participants who received the treatment (26%) had clinical remission compared to placebo (1%).
Not everyone with ulcerative colitis has the gene for TL1A, and the researchers hypothesized that the ones who do would respond better to tulisokibart. To test this hypothesis, the second group consisted of 43 people, all of whom had this gene. This group underwent the same protocols as the first. Across both groups, the researchers found that individuals who expressed the gene had a higher remission rate (32%) than placebo (11%). While the difference in this exploratory group was not statistically significant, it was enough proof to support the next phase of this therapy’s development.
“The potential to use this treatment as a companion diagnostic is an exciting advance in our field that we hope will open doors to additional pharmacogenomic approaches to predicting response to therapies,” says Rubin, who is also Chief of the Section of Gastroenterology, Hepatology, and Nutrition and Director of the Inflammatory Bowel Disease Center at UChicago Medicine.
Rubin served as lead and corresponding author for a paper in The Lancet, which studied another drug called guselkumab, a monoclonal antibody that targets IL-23, the cytokine that drives many immune diseases, including ulcerative colitis. The drug, under the brand name Tremfya, has been used for many years to treat plaque psoriasis and psoriatic arthritis.
The study evaluated the efficacy and safety of guselkumab as a treatment for moderately to severely active ulcerative colitis. The double-blind study followed 701 patients over the course of 44 weeks and randomized them to either guselkumab or a placebo.
The researchers found that those taking the drug had significantly greater clinical remission (23%) than those receiving placebo (8%) at 12 weeks and were more likely to maintain remission at 44 weeks (50% versus 19%). They also found that the overall safety of the drug was favorable and consistent with that found in the approved indications, and more broadly, with the class of IL-23 inhibitors previously studied.
Following the study, the FDA approved the use of Tremfya to treat moderately to severely active ulcerative colitis. In September 2024, the University of Chicago Medicine became the first hospital in the world to administer the drug to a patient with the disease.
In a separate study published in Nature Medicine, Rubin and Eugene B. Chang, a professor of medicine at UChicago, also partnered with researchers from the Chinese University of Hong Kong to identify gut bacterial species that are always present in people with inflammatory bowel disease.
Those findings could be translated someday into a non-invasive, microbiome-based test that could diagnose IBD quickly using fecal samples from patients. This would allow doctors to intervene sooner, before the disease progresses and requires intestinal surgery.
Such advances, along with the promising results of the two clinical trials, offer hope for patients with IBD.
“It’s great to have another effective option for our patients,” Rubin says.
Rubin has been a paid consultant of Johnson & Johnson, the maker of Tremfya.
Source: University of Chicago
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