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Our December 2023 Gastroenterology Month in Review features a pair of American Gastroenterological Association guidelines and articles from the fourth installment of Qazi Corner.
Despite the holiday season on the horizon and 2024 being just around the corner, December 2023 was anything but a slow month in gastroenterology. It kicked off and came to a close with a pair of guideline releases from the American Gastroenterological Association (AGA) for biomarkers in Crohn Disease (CD) and pouchitis management, respectively. HCPLive Gastroenterology also saw its fourth and final installment of Qazi Corner for the year, headlined by innovative new treatments, a rare head-to-head trial, and an overview of yet another guideline, this time from the American College of Gastroenterology (ACG) for Celiac disease.
Despite the year quickly coming to a close, the AGA was hard at work until the very end of 2023, releasing a pair of guidelines for the management of pouchitis and the use of biomarkers for managing CD to begin and conclude the month of December.
The AGA kicked off December 2023 by releasing a new evidence-based guideline with 11 conditional recommendations for the use of biomarkers alongside colonoscopy and imaging studies in patients with CD. Developed by a multidisciplinary panel of content experts and guideline methodologists using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, the guideline is intended to inform the role of commonly used serum and fecal biomarkers as surrogates for endoscopic disease activity in patients with an established diagnosis of CD.
The panel examined the cross-sectional performance of serum C-reactive protein (CRP), fecal calprotectin, and the Endoscopic Healing Index (EHI, Monitr) against the gold standard of endoscopic activity, defined as a Simple Endoscopic Score for Crohn’s Disease ≥3. Investigators collected data on patient population and phenotype, biomarker, reference standard outcome, and test performance from relevant randomized controlled trials or observational studies of diagnostic accuracy, all of which served as evidence used to formulate the guideline recommendations.
Based on the Evidence-to-Decision framework, the panel considered the certainty of evidence, balance of benefit and harms, patient values and preferences, and feasibility, acceptability, equity, and resource use. The guideline panel made 11 conditional recommendations, all of which they reached a consensus on.
The AGA released another guideline toward the end of December, this time focused on the management of pouchitis and inflammatory pouch disorders. Devised by a multidisciplinary panel of content experts and guideline methodologists to support practitioners, it represents the first comprehensive evidence-based guideline on the management of pouchitis.
Together, members of the guideline and evidence synthesis panels developed clinically relevant and focused questions about the primary prevention of pouchitis after IPAA, treatment of pouchitis and prevention of recurrent and/or refractory pouchitis, treatment of Crohn-like disease of the pouch, and treatment of cuffitis. Pertinent data on patients, definition of disease entity, intervention, outcome definition, and timing of assessment were abstracted from relevant randomized controlled trials and observational studies reporting on the efficacy, effectiveness, and adverse effects of therapies of interest.
Panelists used the GRADE approach to rate the certainty of evidence and weigh the magnitude of, and balance among, the benefit and harms of interventions; patients’ values and preferences; and domains of feasibility, acceptability, resource requirements, and impact on health equity. Of note, the panel reached a consensus for all guidelines and made a total of 9 conditional recommendations.
December also saw the fourth installment of Qazi Corner, HCPLive’s quarterly newsletter featuring insight from digestive disease experts at Cleveland Clinic. This issue spotlighted head-to-head trial data for therapies in CD, a new treatment for erosive esophagitis, an ulcerative colitis agent, and the latest ACG recommendations for Celiac disease. The editorial team of HCPLive Gastroenterology sat down with 2 contributors to this issue of Qazi Corner for further insight into their articles.
Among a flurry of US Food and Drug Administration (FDA) decisions this year was that of etrasimod (Velsipity), a sphingosine 1-phosphate (S1P) receptor modulator that was approved for adults with moderately to severely active ulcerative colitis (UC), a decision supported by data from the ELEVATE UC phase 3 registrational program, including the ELEVATE UC 52 and ELEVATE UC 12 trials, assessing the safety and efficacy of etrasimod 2 mg once-daily in patients with UC who had previously failed or were intolerant to at least 1 conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
A summary of both ELEVATE studies as well as a review of their findings and potential directions for future research authored by Shubha Bhat, PharmD, MS, BCACP, was featured in this installment of Qazi Corner, as well as an interview with Bhat about the study’s design, results, and a comparison of etrasimod to the only other currently available S1PR modulator, ozanimod.
Understanding treatment positioning is of paramount importance to aid the optimal use of inflammatory bowel disease (IBD) therapies in clinical practice. The phase 3b SEQUENCE study, spotlighted by Katie Falloon, MD, in the fourth issue of Qazi Corner, was particularly useful for advancing treatment positioning in Crohn disease (CD) because it directly compared the efficacy and safety of ustekinumab and risankizumab.
In an interview with HCPLive, Falloon described the various medications available for IBD with different mechanisms of action, safety profiles, and modes of delivery. Although she noted this was a good thing for both patients and providers, she also pointed out uncertainty regarding the positioning of these therapies and the importance of trials like SEQUENCE for addressing these issues.