Gastroenterology

The NDA submission was supported by positive data from the phase 3 PHALCON-NERD-301 study and has been assigned a standard 10-month review with a PDUFA target action date of July 19, 2024.

The final quarterly issue of the year touches on head-to-head trial data, a new treatment for erosive esophagitis, an ulcerative colitis agent, and the latest ACG recommendations for Celiac disease.e.

An expert reviews the updated recommendations of the American College of Gastroenterology guidelines on the evaluation and management of celiac disease.

While more studies are needed to ensure the safety of long-term therapy with PCABs, this study establishes a role for the use of vonoprazan in the healing and maintenance of healing in patients with erosive esophagitis.

Ustekinumab is currently the only anti-interleukin therapy approved for the treatment of ulcerative colitis, but given the superior performance of risankizumab in CD patients, it will be interesting to see data regarding its efficacy in UC.

The S1PR modulators are currently positioned to serve as a great treatment option for patients with moderate disease who are hesitant to escalate to a biologic treatment.

The guideline was developed by a multidisciplinary panel and consists of 11 conditional recommendations for the use of biomarkers in the management of Crohn disease.

Investigators ranked ChatGPT responses to healthcare professional-oriented questions about IBD as more useful and reliable than the model’s responses to patient-oriented questions.

Results showed patients treated with vedolizumab experienced less dose escalation and were at a decreased risk of requiring dose escalation compared to patients treated with adalimumab and infliximab.

November’s Gastroenterology Month in Review features an FDA approval, the discontinuation of a phase 3 clinical program, and news about Clostridioides difficile testing and risk factors.

We kick off our annual recap series with some reflections from our expert advisory board, on topics ranging from AI and cell therapies, to semaglutide and RSV vaccines.

Data from the phase 3 study confirmed the lot consistency, immunogenicity, safety, and tolerability of a toxoid-based Clostridioides difficile vaccine.

Pretreatment vitamin D levels were associated with endoscopic improvement in patients with UC and decreased C-reactive protein levels in patients with CD.

Ciprofloxacin, ceftriaxone, and piperacillin/tazobactam showed the greatest associations with adverse drug reaction case reports related to CDI.

Although respondents agreed on the relevance of the gut microbiota in IBD, attitudes toward the clinical application of microbiome-based therapies varied.

A retrospective cohort study of inpatient encounters from 3 hospitals in the Duke University Health System showed greater rates of testing among White patients compared to Black and NWNB patients.

Our gastroenterology month in review highlights multiple FDA approvals, conference coverage from ACG 2023, and other top news in gastroenterology.

VOQUENZA® provides quicker healing than Lansoprazole, according to an FDA-approved Phase 3 study

A retrospective analysis of data from the US National Inpatient Sample revealed the prevalence of fibromyalgia and chronic fatigue syndrome was significantly increased in patients with IBS compared to those without IBS.

Marla Dubinsky, MD, discusses findings from the LUCENT program and their role in the recent FDA approval of mirikizumab for ulcerative colitis.

Results from both phase 2 trials were presented in poster abstracts at ACG 2023.

In this interview, Remo Panaccione, MD, discusses results from the long-term extension of the GALAXI phase 2 study for guselkumab in Crohn disease and their implications in clinical practice.

Findings were presented in an abstract at ACG 2023, highlighting the importance of addressing bowel urgency in patients with ulcerative colitis.

New data from ACG 2023 shows etrasimod-treated patients were able to achieve UC remission, with or without concomitant steroid treatment at baseline.

Eli Lilly and Company announced the FDA approval of mirikizumab (Omvoh) for moderately and severely active ulcerative colitis in adults on October 26, 2023.

Results showed higher-exposure dupilumab met the study’s primary endpoint for peak esophageal intraepithelial count ≤6 eos/high-power field.

New QUASAR analysis shows patients with intolerance or failed response to advanced therapies nonetheless achieved benefit with guselkumab.

Results presented in a paper at ACG 2023 showed upadacitinib was more effective than ustekinumab for achieving clinical response and endoscopic remission.

New PUNCH CD3 analyses show patients who were treated with live fecal microbiota therapy improved their gut health at 8 weeks—which correlated with improved quality-of-life scores.

Feuerstadt reviews ACG 2023 data showing live microbiota therapy provides consistent protection against rCDI in one of the most vulnerable patient populations.