Gastroenterology

The July 2024 gastroenterology month in review highlights FDA news, GI pipeline updates, and a new clinical practice update from the American Gastroenterological Assocation.

Grady explains the significance of the recent FDA approval of the first blood-based test for primary CRC screening and his hope for its impact on overall screening rates and compliance.

The phase 2 trial did not meet its primary endpoint for mean change in Crohn’s disease activity index in either VTX958 dosing group.

The approval of Guardant Health’s Shield test makes it the first blood test to be approved as a primary screening option for CRC and the first to meet Medicare coverage requirements.

New research suggests combined treatment with fecal microbiota transplant and anti-PD-1 inhibitors may help overcome immune checkpoint inhibitor resistance in gastrointestinal cancers.

Data from INSPIRE and COMMAND were used to support risankizumab’s FDA approval for ulcerative colitis, demonstrating the IL-23 inhibitor’s impact on clinical remission.

The novel potassium-competitive acid blocker now boasts 3 FDA approvals across erosive and non-erosive GERD, expanding the treatment armamentarium for patients and clinicians.

Vonoprazan (Voquezna), the first major innovation in GERD treatment in more than 30 years, is now FDA-approved for both erosive and non-erosive GERD.

Announced on July 18, 2024, the FDA approval for heartburn relief associated with non-erosive GERD is based on the phase 3 PHALCON-NERD-301 trial.

Levinthal explains recent advances in the understanding of CVS and how the AGA clinical practice update reflects new information about its diagnosis and management.

A clinical practice update from the American Gastroenterological Association is providing clinicians with an overview of the diagnosis and management of CVS.

Chehade reviews key findings from the phase 3 EoE kids trial and how they inform dupilumab’s use in children 1-11 years of age with eosinophilic esophagitis.

After a busy first half to 2024, a number of high-impact FDA decisions await the healthcare industry through December.

The June 2024 gastroenterology month in review highlights FDA news and other pipeline developments in GI as well as the publication of the latest installment of Qazi Corner.

Findings from a post hoc analysis of True North and its open-label extension highlight ozanimod’s rapid onset of action and durability in advanced therapy-naive patients with UC.

Loftus explains the significance of IL-23 and Th17 in IBD and key trial data supporting the FDA approval of risankizumab in ulcerative colitis.

Positive topline results showed guselkumab (Tremfya) SC induction therapy met all primary and secondary endpoints, suggesting similar clinical benefit to IV induction seen in GALAXI.

The approval is based on data from a pair of phase 3 studies and makes risankizumab-rzaa the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn’s disease.

The second quarterly issue of 2024 reviews outcomes in liver disease after bariatric surgery, glucagon’s role in esophageal impaction management, and outcomes after cuffitis following pouch creation.

Qazi discusses implications from a recent study exploring the impact of post-IPAA cuffitis on long-term pouch outcomes and the risk of developing strictures and fistulas.

Findings suggest cuffitis after ileal pouch-anal anastomosis is linked to long-term complications including strictures and fistulas, potentially contributing to a greater risk of pouch failure.

Qazi reviews findings from a recent study suggesting glucagon does not have a significant impact on esophageal foreign body impaction resolution.

Findings from a recent randomized controlled trial suggest glucagon does not improve EFBI resolution, time of endoscopy, or extraction length.

Qazi discusses the impact of bariatric surgery on outcomes in patients with decompensated cirrhosis, highlighting its benefit in this patient population.

The retrospective analysis highlights improved outcomes among patients with obesity and a history of bariatric surgery hospitalized with decompensated cirrhosis.