Gastroenterology Month in Review: November 2024

With 2024 quickly drawing to a close and 2025 on the horizon, November saw the start of a final push to end the year on a high note in the field of gastroenterology.

A fitting continuation to what has been a bustling couple of months in this specialty, November was characterized by the announcement of a supplemental Biologics License Application (sBLA) from Johnson and Johnson for a subcutaneous induction regimen of guselkumab (Tremfya) in ulcerative colitis (UC) as well as coverage from the 2024 Annual North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In the GI Pipeline

J&J Submits sBLA for Guselkumab (Tremfya) Subcutaneous Induction Regimen in UC

On November 22, 2024, Johnson & Johnson announced the submission of an sBLA seeking approval of a subcutaneous induction regimen of guselkumab (Tremfya) for the treatment of adults with moderately to severely active UC.

Supported by data from the phase 3 ASTRO study, the filing builds upon the recent US Food and Drug Administration (FDA) approval of guselkumab for this indication in September 2024.

"With the ASTRO study in UC and the GRAVITI study in Crohn's disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers," Esi Lamousé-Smith, MD, PhD, vice president, gastroenterology disease area lead, immunology, at Johnson & Johnson Innovative Medicine, said in a press release. "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients."

HCPLive at NASPGHAN 2024

Akif Shameem, MD: Generalized Anxiety Disorder Linked to Longer Hospitals in Children with IBD

Findings from this study were presented at the 2024 NASPGHAN meeting in Hollywood, Florida, and suggest children with inflammatory bowel disease (IBD) who have generalized anxiety disorder (GAD) endure longer hospital stays than those without GAD.

In addition to statistically significantly longer hospital stays, patients with IBD and GAD also faced greater average total charges, more frequent need for parenteral nutrition, and greater surgery rates.

Trends in Risk & Management Strategies for Water Bead Injuries, with Patrick Reeves, MD

Results from an analysis of data from a nationally representative sample of emergency room data point to a consistent increase in water bead injuries beginning in 2013, but a significant increase in 2020 and beyond, with study investigators highlighting 9% of the more than 6000 cases requiring escalation of care.

Linaclotide Effective for Functional Constipation in Children with Neurodevelopmental Disorders

Use of linaclotide (Linzess) offers significant benefits for relief of functional constipation among children with neurodevelopment disorders, according to findings from an analysis of the pivotal phase 3 trial supporting its approval.

Results indicated use of linaclotide was associated with a beneficial treatment effect for all efficacy endpoints, with the observed improvements in bowel function similar to those observed in the overall study population.

ACG 2024 Conference Coverage

Novel Gas-Sensing Capsule May Provide New Tool for Assessing Motility Disorders

New research suggests the potential utility of a novel gas-sensing capsule for assessing regional transit time across multiple areas of the GI tract to diagnose motility disorders, highlighting agreement between the capsule and an FDA-cleared wireless motility capsule for measuring both gastric emptying time and colonic transit time. Now that the FDA-cleared capsule is no longer being manufactured, these findings suggest the novel gas-sensing capsule may be a viable replacement.

Disparities in IBS Clinical Trial Participation Suggest Healthcare Research Inequities

Findings from this study highlight significant racial, ethnic, gender, and geographic disparities in participation in randomized clinical trials for FDA-approved irritable bowel syndrome (IBS) therapies, potentially compromising the generalizability of trial results.

Specifically, the study found an overrepresentation of female and African American patients, a notable lack of reporting on ethnicity, and worse socioeconomic indicators in counties without access to clinical trial sites.

Stool Diary App Aids Vibrating Capsule Compliance, Efficacy for Chronic Constipation

A stool diary app may help improve treatment compliance and certain constipation symptoms in patients with chronic idiopathic constipation (CIC) prescribed the vibrating capsule (Vibrant), according to findings from a post-marketing presented at the ACG 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania.

Results showed patients who took the vibrating capsule and kept a daily electronic stool diary app had significantly greater first reorder rates and demonstrated significant improvements in key symptoms of constipation, suggesting the app may provide incremental benefit and facilitate treatment monitoring in CIC.