Guselkumab Approved for Ulcerative Colitis, Tradipitant Receives CRL: GI News from September 2024
Key Insights
Guselkumab (Tremfya) received FDA approval for treating moderately to severely active ulcerative colitis (search), marking it as a novel dual-acting monoclonal antibody.
Vanda Pharmaceuticals' tradipitant received a Complete Response Letter from the FDA for treating gastroparesis (search) symptoms, prompting the need for additional studies.
Research indicates that the effectiveness of fecal microbiota transplantation (FMT) for IBS (search) may depend on the delivery method used.
The field of gastroenterology saw significant developments in September 2024, with an FDA approval and a Complete Response Letter (CRL) headlining the news. New research also shed light on treatment responses and risks associated with various gastrointestinal conditions.
Guselkumab (Tremfya) Approved for Ulcerative Colitis
Guselkumab (Tremfya) secured FDA approval for the treatment of adults with moderately to severely active ulcerative colitis (search) (UC). This approval marks guselkumab as the first and only fully human, dual-acting monoclonal antibody that blocks interleukin (search) (IL)-23 while also binding to CD64 (search), a receptor on cells that produce IL-23 (search). The decision was based on data from the phase 2b/3 QUASAR study.
"Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis (search), and importantly, normalization in the endoscopic appearance of the intestinal lining," said David Rubin, MD, director of the Inflammatory Bowel Disease (search) Center at University of Chicago Medicine and lead investigator for the QUASAR program. He added that this approval builds on the established safety profile of the IL-23 (search) inhibitor.
CRL Issued for Tradipitant in Gastroparesis
Vanda Pharmaceuticals received a CRL from the FDA for tradipitant, a drug intended to treat symptoms of gastroparesis (search). The FDA suggested that Vanda conduct additional studies, a request that Vanda argues is inconsistent with expert advice and the scientific understanding of gastroparesis.
Treatment Response in IBS and IBD
New research indicates that abdominal pain and discomfort remain significant issues for patients with irritable bowel syndrome (search) (IBS (search)), leading to reduced productivity and impaired daily activities. The study also found that many IBS patients report dissatisfaction with their treatments due to inadequate symptom control.
Another study suggests that the presence of faecalibacterium prausnitzii and Roseburia hominis may predict whether a patient with inflammatory bowel disease (search) (IBD (search)) and chronic fatigue will respond to thiamine treatment. This offers insight into why some patients benefit more from vitamin B1 therapy than others.
Furthermore, a study exploring fecal microbiota transplantation (FMT) for IBS (search) treatment found that the delivery method impacts its effectiveness. FMT delivery via endoscopy, nasojejunal tube, or rectal enema showed greater potential for symptom improvement and enhanced quality of life.
"This study revealed that while the overall pooled estimates did not show a significant benefit of FMT for IBS (search), subgroup analyses revealed that FMT delivered via routes with more direct delivery to the gut, such as endoscopy, nasojejunal tube, or rectal enema, and in well-designed studies, may be an effective treatment option for improving symptoms and quality of life in IBS patients," wrote Pei-Chun Lai, MD, of National Cheng Kung University Hospital in Taiwan, and colleagues.
GI Risks and Parkinson's Disease
Research has uncovered a notable association between upper gastrointestinal mucosal damage and an increased risk of developing Parkinson's disease. Analyzing data from nearly 20,000 patients who underwent upper endoscopy with biopsy, investigators found that those with endoscopic evidence of mucosal damage had a higher risk of Parkinson's diagnosis compared to those without such damage.
Steatotic Liver Disease and Cancer Risk
New findings highlight a significant link between steatotic liver disease (search) (SLD) and cancer, particularly an elevated risk of certain cancers in metabolic dysfunction-associated steatotic liver disease (MASLD (search)) and MASLD with increased alcohol intake (MetALD (search)). Compared to individuals without SLD, patients with MASLD, MetALD, and other combination etiologies faced a greater risk of developing liver cancer and extrahepatic cancers, including gastrointestinal cancers.