10 Highlights From ACG's 'Virtually' Perfect Annual Meeting

David A. Johnson, MD


November 09, 2020

This transcript has been edited for clarity.

Hello. I'm Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia.

I just attended the first-ever virtual annual meeting of the American College of Gastroenterology (ACG). It was originally going to take place in Nashville, but because of COVID-19 it was held virtually instead. Despite that change, it was, in my mind, "virtually" perfect. My compliments to the leadership and the infrastructure of ACG for pulling this off without a hitch. It was seamless and amazing.

I wanted to give you some 30,000-foot-view highlights of presentations that I thought may be meaningful to your practice, as they certainly were for mine.

Pancreatic Cysts: Progression and Postsurgical Follow-up

The first two studies involved pancreatic cysts, which are being identified more frequently during imaging.

The first study came from a group at NewYork-Presbyterian/Columbia University Medical Center in New York City, and looked at the real-world data on the malignant progression of low-risk cysts.

From a database of 137,970 patients with pancreatic cysts, investigators identified 14,279 who met low-risk criteria. At 5 years, they found a cumulative progression rate to pancreatic carcinoma of 2.2%. This rate was 1.5% in patients without diabetes, but it increased to 3.1% in those with a prior history of diabetes and to 4.6% in those with new-onset diabetes.

This study shows us that new-onset diabetes is significantly associated, and diabetes somewhat less so, with progression. At the very least, we should be including A1c, glycemic indices, and other markers for diabetes in our pancreatic cyst surveillance algorithms.

The second study on pancreatic cysts came from Cleveland Clinic Foundation researchers, who analyzed a database of patients diagnosed over a decade (2008-2018).

Of 1789 patients who had pancreatic cysts, 104 underwent surgical intervention, which for approximately one third was pancreaticoduodenectomy and for the other two thirds was distal pancreatectomy. The majority of indications (63%) were intraductal papillary mucosal neoplasms; but on surgical pathology, 27% had adenocarcinoma and 14% had high-grade dysplasia.

Between 1 and 5 years post-surgery, recurrent cysts increased from 34.5% to 64.8%, high-risk transformation increased from 5.1% to 13.7%, and malignant transformation increased from 11.7% to 19%. Given that there was a more than 10% increase in malignant transformation by 1 year and 19% by 5 years, incredibly close follow-up is needed in patients who require intervention for pancreatic cysts.

Immune-Mediated Diarrhea and Colitis

The next study comes from MD Anderson investigators and dealt with the extremely important indication of immune-mediated diarrhea and colitis (checkpoint colitis), which is becoming an increasing problem, particularly for inpatient consults. Checkpoint colitis shares some similarities with inflammatory bowel disease, but it's a distinct form with acute onset and rapid progression that leads to potential complications, including bowel perforation and death.

Guidelines from the American Society of Clinical Oncology suggest that first-line therapy should consist of steroids. Escalation to biologic agents should be considered for those patients who need continued treatment, with infliximab recommended first and vedolizumab suggested as a backup therapy.

In this study, investigators enrolled 150 patients, providing the first sample size large enough to compare vedolizumab and infliximab. The vedolizumab group notably had a shorter duration of steroid treatment (35 vs 50 days, respectively), lower steroid tapering attempts, and shorter duration of hospital stay.

Vedolizumab was administered at three or more doses, and infliximab at only one to two doses.

The efficacy in achieving clinical remission was comparable between the groups, but the vedolizumab arm had a lower recurrence rate for immune-mediated diarrhea and colitis compared with infliximab (13% vs 28%, respectively). There was a slight delay in clinical response with vedolizumab (17 vs 10 days, respectively), which is something that has also been suggested by previous studies.

These results indicate that vedolizumab is a drug that we should consider using sooner rather than later for this complicated patient population.

COVID-19 Pandemic

Of course in 2020 you can't avoid the topic of the COVID-19 pandemic. This was the focus of the next two studies, which analyzed the relative risk for mortality and morbidity relating to COVID-19.

The first such study looked at liver enzyme elevation in confirmed cases of COVID-19. They observed liver injury — defined as transaminases or alkaline phosphatase and total bilirubin three times or two or more times greater than the upper limit of normal, respectively — in 20.5% of patients. Liver injury was also more likely to occur in in African Americans.

The pattern of liver injury was typically hepatocellular (61%), followed by mixed pattern (34%) and, more rarely, cholestatic (5%). What this meant in terms of prognostication was that patients with liver injury had a higher risk for mortality (relative risk [RR], 4.26), intensive care unit admission (RR, 5.52), intubation (RR, 11.01), and 30-day readmission rate (RR, 1.81). This is clearly something that we need to start considering when accounting for risk mitigation in our patients with COVID-19.

The second study assessed patients with COVID-19 who presented with diarrhea via a meta-analysis of 38 studies (8407 patients). The study's authors report that patients presenting with diarrhea symptoms were more likely to have severe disease (odds ratio, 1.63).

Taken together, these two studies indicate that liver injury and diarrhea at presentation significantly increased the relative risk for patients with COVID-19.

Microbial Therapy for C difficile Infection

The next two studies I'd like to highlight for you dealt with Clostridioides difficile infections, a problem for which we desperately need a prevention strategy.

The first of these was a multicenter study looking at a biologically derived microbiome therapeutic purified from acute spores for recurrent C difficile.

I love the inclusion criteria the study used, which called for patients to have had three or more episodes of recurrent C difficile within 12 months, meaning that they had an incredibly high relapse potential. All patients received 10-21 days of vancomycin or fidaxomicin and then were assessed for safety and efficacy at 8 weeks.

Patients receiving this therapeutic experienced a lower rate of recurrent C difficile than those receiving placebo (11.1% vs 41.3%, respectively). This translated into a sustained clinical response of 88.9% vs 58.7%. The safety profile was also good and similar to that observed with placebo.

The next study assessed the potential of another microbial therapy for C difficile, which was designed to restore microbiome diversity.

Investigators behind this double-blind, placebo-controlled trial enrolled 198 patients. The entry criteria were less intense than those of the previously noted study. To be included, patients either had to have recurrent C difficile or be deemed at high risk for recurrence (> 65 years).

The sustained clinical cure was significantly greater with the investigational therapeutic than with placebo (74.5% vs 61.5%, respectively) and had a relative risk reduction of 33%. The percentage of patients who experienced sustained clinical cure at 8 weeks was also significantly higher for the therapeutic group (73.5% vs 55.4%, respectively).

Both of these studies offer interesting findings with therapies that we hope are only needed as short-term options. We need biologic intervention therapies for this indication. If you're treating patients with C difficile in your hospitals, you will receive no payment if they are readmitted within 30 days of discharge. Therefore, hospitals are going to love strategies to mitigate potential readmission.

More Guidance on Treating Eosinophilic Esophagitis

There were two noteworthy studies on eosinophilic esophagitis, a disease we commonly encounter in our adult population and require more direction on how to treat. Both studies were presented by Dr Evan Dellon, a recognized expert on this topic, from the University of North Carolina at Chapel Hill.

In the first study, Dellon and colleagues investigated the use of a novel fluticasone propionate orally disintegrating tablet. This study was following up on a phase 2b analysis looking at this tablet as induction therapy for up to 12 weeks. The current study offers safety and efficacy results on maintaining remission at 52 weeks.

The best induction dose seemed to be 3 mg twice a day, which resulted in an 80% response rate, compared with 67% for a 3-mg dose at bedtime. However, over the course of the 52-week study, it was determined that the product had the best safety and risk benefit when taken as 3 mg at bedtime.

The other study presented by Dellon investigated the use of dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13, the key drivers for type 2 inflammation of eosinophilic esophagitis. This drug has been around for quite some time, used for allergic asthma with allergic eosinophilia as well as for atopic dermatitis. Although this is not a new drug, it is potentially useful in a new indication.

In this phase 3 study, investigators administered dupilumab at 300 mg subcutaneously and compared it with placebo. They studied its efficacy at 24 weeks for achieving a peak esophageal intraepithelial eosinophil (eos) count of < 6 eos/high-power field, which occurred in 59.5% of those receiving dupilumab vs 5.1% of those receiving placebo. There were significant improvements regarding symptoms on the endoscopic reference score and the histologic scoring system.

Dupilumab is something to consider in the short term, as we clearly need better guidance on how to best treat eosinophilic esophagitis.

Bowel Prep

The final study I want to highlight dealt with colon preparations. In this multicenter study of 515 patients, investigators compared an oral tablet formulation for colon preparation with the standard preparation containing PEG3350, electrolytes, and ascorbate (PEG-EA).

The results indicated that the oral tablet formulation was noninferior regarding the rate of cleansing success and was superior in terms of global assessment and for the right colon. There were no serious adverse events noted with the oral tablet formulation as compared with PEG-EA. This tablet formulation doesn't contain sodium phosphate, which has really been a problem for OsmoPrep, which led to renal failure and a subsequent black box warning from the US Food and Drug Administration.

I think patients will like these tablets, which are administered in the form of 12 tablets followed by water, and taken as a split dose. Tablet formulation looks like something worthy of considering in our patients undergoing colonoscopy.

ACG's first virtual annual meeting certainly didn't disappoint this year. There was a lot of great new science, which will help us in both scientific research and patient care. I recommend that you look at these highlighted abstracts, in addition to the other wonderful presentations. Hopefully this information will drive your clinical discussions.

I'm Dr David Johnson. Thanks for listening.

David A. Johnson, MD, a regular contributor to Medscape, is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. His primary focus is the clinical practice of gastroenterology. He has published extensively in the internal medicine/gastroenterology literature, with principal research interests in esophageal and colon disease, and more recently in sleep and microbiome effects on gastrointestinal health and disease.

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