Gastroenterology Month in Review: September 2024

As the summer months come to a close and fall looms on the horizon, September was a fitting start to what is sure to be a busy next couple of weeks in the field of gastroenterology. Characterized by an FDA approval as well as a Complete Response Letter (CRL), new research informing treatment response and different risks in various gastroenterological conditions, and the 2024 annual Gastroenterology and Hepatology Advanced Practice Providers (GHAPP) conference, this September 2024 month in review spotlights HCPLive’s top coverage of the latest in GI.

Gastroenterological Pipeline News

FDA Approves Guselkumab (Tremfya) for Ulcerative Colitis

The sole gastric FDA approval of September was that of guselkumab (Tremfya) for the treatment of adults with moderately to severely active ulcerative colitis (UC), making it the first and only approved fully human, dual-acting monoclonal antibody that blocks interleukin (IL)-23 while also binding to CD64, a receptor on cells that produce IL-23. The decision was based on data from the ongoing phase 2b/3 QUASAR study.

“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 Rubin, MD, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine and lead investigator for the QUASAR program, said 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.”

FDA Issues CRL to Vanda Pharmaceuticals’ Tradipitant for Gastroparesis Symptoms

The other major piece of FDA news from the month of September was the FDA’s decision to issue a CRL to Vanda Pharmaceuticals’ tradipitant for the treatment of symptoms in gastroparesis.

Despite Vanda’s request that the FDA convene an expert advisory committee to review the application and advise the Commissioner on the approval of this application, no meeting was held and instead, the CRL suggested that Vanda conduct additional studies with a design and duration Vanda asserted was inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of gastroparesis.

Treatment Response

Patients with IBS Report Treatment Dissatisfaction, Lack of Symptom Control

New research highlights abdominal pain and discomfort as bothersome symptoms in patients with irritable bowel syndrome (IBS) with constipation (IBS-C) and IBS with diarrhea (IBS-D), leading to greater rates of presenteeism, overall work productivity loss, and daily activity impairment. Additionally, study results showed most patients with IBS reported general treatment dissatisfaction due to a lack of control of bowel-related and abdominal symptoms, although prescription medication use was linked to greater symptom control satisfaction than taking over-the-counter (OTC) medications alone.

Study Unlocks Key Bacteria That Explains Why Only Some with IBD Respond to Thiamine

Findings from this study suggest the presence of faecalibacterium prausnitzii and Roseburia hominis may determine whether a patient with inflammatory bowel disease (IBD) and chronic fatigue will respond well to thiamine treatment, providing novel evidence as to why some patients respond better to vitamin B1 than others.

Fecal Microbiota Transplant Delivery Method May Impact Benefit for Treatment of IBS

In this study exploring the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of IBS, investigators found that FMT delivery through endoscopy, nasojejunal tube, or rectal enema had a greater impact on symptom improvement and quality of life.

“This study revealed that while the overall pooled estimates did not show a significant benefit of FMT for IBS, 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,” Pei-Chun Lai, MD, of National Cheng Kung University Hospital in Taiwan, and colleagues wrote.

Risk in GI

Upper GI Mucosal Damage Linked to Increased Risk of Parkinson Disease

Although previous research has explored correlational links to a history of H pylori infection, this study provides novel evidence of a significant association between upper gastrointestinal mucosal damage and the risk of developing Parkinson disease. Leveraging data for nearly 20,000 patients who underwent upper endoscopy with biopsy from a Mass General Brigham-based electronic database, investigators found those with positive endoscopic findings for mucosal damage had a greater risk of being diagnosed with Parkinson disease compared with those without mucosal damage.

MASLD, MetALD Linked to Increased Risk of Liver, Gastrointestinal Cancers

New research suggests a significant association between steatotic liver disease (SLD) and cancer, with study findings highlighting an increased risk of certain cancers in metabolic dysfunction-associated steatotic liver disease (MASLD) and MASLD with increased alcohol intake (MetALD). Compared with those without SLD, patients with MASLD, MetALD, and other combination etiology had a greater risk of developing liver cancer and extrahepatic cancer, including gastrointestinal cancer.

Gastroenterology and Hepatology Advanced Practice Providers (GHAPP) Conference

Positioning Medications in Crohn Disease, with Teddy Solomon, MSN, NP

Given recent evolutions in the management of Crohn disease driven by advancements in pharmacologic therapies and a deeper understanding of disease pathophysiology, knowing how to position different therapies in the growing treatment armamentarium is of paramount importance for healthcare providers. In this Q&A based on his presentation at the 2024 annual GHAPP conference in National Harbor, Maryland, Teddy Solomon, MSN, NP, a nurse practitioner at Cedars-Sinai Medical Center, reviews how to navigate the different treatment options available for patients.

Managing Disorders of Gut-Brain Interaction, with Nicole Martinez de Andino, NP

Disorders of gut-brain interaction (DGBI), formerly known as functional gastrointestinal disorders, affect more than 40% of the global population. Despite their prevalence, the management of DGBI in clinical practice is often suboptimal, largely attributable to the lack of abnormal endoscopic or radiologic findings or objective biomarkers that can be identified during routine clinical evaluation to aid diagnosis.

In this interview with HCPLive, Nicole Martinez de Andino, NP, a nurse practitioner at Augusta University Medical Center, reviews commonalities in the management of different DGBI based on her presentation at the 2024 annual GHAPP conference in National Harbor, Maryland.