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The first iteration of Crisis Point addresses the obesity crisis in the United States and beyond, with expert interviews and discussion.  

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William D Chey, MD, FACG professor of gastroenterology and nutrition sciences at Michigan Medicine at the University of Michigan, gave The J Edward Berk Distinguished Lecture at the 

American College of Gastroenterology 2021 conference

. Chey’s lecture was titled “The End of the Beginning: Megatrends in Gastroenterology”.

“I think we're in an incredibly exciting time in 

,” Chey said. “And I don't say that lightly because I understand, as a clinician, all the challenges that we face in the clinic every day.”

Chey described the treatment of irritable bowel syndrome (IBS) as a team sport. It’s no longer only about gastroenterologist care but an integrated team involving dietitians, behavioral therapists and possibly even complementary alternative medicine providers.

Diet therapies are a cornerstone of treatment. When talking to patients with IBS, they almost invariably say that the 2 biggest triggers for their symptoms are when they eat and when they’re stressed or anxious.

“Trying to create solutions to address those realities are critically important,” Chey said. “And in fact, they’re evidence based now.”

The low FODMAP diet, the Mediterranean diet, increased fiber, are a few examples of potential dietary solutions that Chey mentioned. Currently, the low FODMAP diet is the most evidence-based diet strategy for patients with IBS.

“When comparing to a habitual diet, the low FODMAP diet is the most effective diet intervention that’s been evaluated in randomized controlled trials,” Chey explained.

While the dataset surrounding the low FODMAP diet is imperfect, in general the data are trending in a positive direction. In addition to improving overall symptoms, the FODMAP diet has been shown to be effective for abdominal pain and bloating.

When treating patients with IBS, diet behavior and medication are equally important. Psychological treatments should be considered with any level of gastrointestinal (GI) symptoms.

Compared to 7 or 8 years ago when it was common practice to only consider psychological treatment in cases with severe GI symptoms, it’s a paradigm shift. The patient’s insight into the relationship between anxiety and their GI symptoms is really the key, Chey said.

A patient who has the insight and is willing to engage and follow up with a therapist is an excellent candidate for behavioral therapy regardless of whether they have mild, moderate or severe symptoms.

“For patients with IBS, the most efficacious behavioral interventions were minimal contact cognitive behavioral therapy,” Chey explained.

Gut-directed hypnosis and cognitive behavioral therapy (CBT) were found to be more efficacious than education or routine care after being evaluated in randomized control trials. This shows that a multidisciplinary care model is an ideal treatment approach.

Moving away from treatment silos and into an integrated care model is where we want to go, Chey said. Collaborative, multi-specialty care that’s team-based with the patient at the center.

Chey shared the details of a randomized controlled trial conducted in Australia that focused on traditional care versus integrated care models. Until this point, there hasn’t been evidence-based support showing that integrated care is a better method until this publication.

The study showed a group of individuals with a diverse set of functional GI disorders (65% IBS) that 84% reported on verbal response of their symptoms with integrated care compared to 57% with the traditional care model. Even when looking at the cohort of individuals with IBS, the benefit offered by integrated care was statistically significant.

“So, multidisciplinary integrated care models improve clinical outcomes," Chey said. “I've shown you that they may reduce costs, there's some data to suggest that perhaps you could build an argument for that, and they redistribute responsibilities in ways that benefit patients and providers.”

Articles

In his lecture, The End of the Beginning: Megatrends in Gastroenterology, William Chey, MD, emphasizes the importance of a multidisciplinary integrated care approach to treating IBS.

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William Chey, MD, Explores Integrated Care for IBS Treatment at ACG 2021

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The absence of urgency could be a useful metric in gauging colonic inflammation in patients with 

2021 American College of Gastroenterology (ACG) Annual Meeting

, a team led by Marla C. Dubinsky, MD, Professor of Pediatrics, Icahn School of Medicine at Mount Sinai, found patients with the absence of urgency had significantly greater reductions in levels of inflammatory biomarkers C-reactive protein (CRP) and fecal calprotectin (fCLP) in a cohort of patients treated with mirikizumab.

In the study, 249 patients were equally randomized to receive intravenous placebo, 50 or 200 mg mirikizumab with exposure-based dose increase possibility or fixed mirikizumab 600 mg every 4 weeks.

The 106 patients who achieved clinical response were then re-randomized into a double-blind maintenance study with either 200 mg mirikizumab subcutaneously every 4 or 12 weeks through 52 weeks.

, Dubinsky explained how the results show clinicians should pay attention to urgency as a useful metric for patient severity.

Dubinsky also said clinical trials for inflammatory bowel disease should start to focus more on targeting endpoints such as urgency or the lack of urgency.

Videos

An absence of urgency was associated with greater reductions in levels of inflammatory biomarkers C-reactive protein and fecal calprotectin in a cohort of patients treated with mirikizumab.



Marla C. Dubinsky, MD: Measuring Urgency in Ulcerative Colitis

An investigational therapy for recurrent 

Clostridioides difficile infections (CDI)

 ultimately cut the absolute risk of recurrence by 27% in comparison to placebo.

, shows SER-109, developed by Seres Therapeutics, shows the investigational oral microbiome therapeutic reduces the risk of recurrence, even in high risk patients, including those taking acid-reducing medications like proton pump inhibitors (PPIs) and H2 blockers, which account for 40.7% of patients.

The data presented comes from the multicenter, randomized, placebo-controlled phase 3 ECOSPOR III trial where topline data showed SER-109 was superior to placebo in reducing CDI recurrence at 8 weeks to achieve the primary efficacy endpoint. The treatment resulted in a sustained clinical response rate of approximately 88% at 8 weeks following treatment and a 27% absolute reduction of recurrence of CDI, which is a relative risk reduction of 68%.

Previously, the company presented 24 week clinical data that shows SER-109 significantly reduced recurrence compared to placebo over 24 weeks (21% vs. 47%).

The treatment was also well-tolerated, with no treatment-related serious events observed, as well as an adverse event profile comparable to placebo.

“Those living with gastrointestinal issues are faced with limited treatment options to help address some of the debilitating symptoms they face each day. While many turn to acid-reducing medicines, previous studies have shown that this can result in a higher risk of recurrent 

 infection,” said Lisa von Moltke, MD, Chief Medical Officer at Seres, in a statement. “We were pleased to see that with the administration of SER-109, subjects in the study experienced a lower CDI recurrence rate regardless of their risk factors, including the use of acid-reducing medications—a highly prevalent characteristic in this study population.”

Seres expects to complete both phase 3 studies and the pending open-label study database before filing a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in mid-2022.

Approximately 88% of patients treated with SER-109 achieved a sustained clinical response at 8 weeks. 

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SER-109 Reduces Recurrence of C Difficile Infections

Jessica R Allegretti, MD, MPH, FACG, Director of Clinical Research, Director, Fecal Microbiota Transplant Program, Associate Director, Crohn's and Colitis Center, Bringham and Women's Hospital, Assistant Professor of Medicine, Harvard Medical School, presented her PRISM3 study at the 

The study was a double-blind, randomized, placebo-controlled trial that included adults who received standard-of-care for recurrent 

Cp101 is an investigational orally administered microbiome therapeutic designed to restore microbiome diversity and enable early intervention in the management of recurrent CDI, according to the study.

Last year at ACG, Allegretti presented data showing that CP101 was significant at preventing recurrent CDI at week 8 post-therapy. This year, Allegretti explained, they looked at microbial diversity.

"It's extremely important in today's age to develop new safe microbiome therapeutics for C diff," Allegretti said.

The next step for CP101 is going to be a large phase 3 study, PRISM4, which should be enrolling later this year. 

According to Allegretti, antibiotic stewardship is one of the best tools that clinicians have to fight CDI, which has risen to epidemic levels. CP101 isn't the only CDI treatment in development.

Several companies are working on novel live biotherapeutic products. FMT is effective and safe but it's not viable long-term. Allegretti shared how exciting it is to have multiple treatments in development that are already showing promising results.

"I think it's a really great time to be working in this space," Allegretti said. 

A new study presented at ACG 2021 shows microbiome therapeutic CP101 effective in preventing recurrent CDI by increasing intestinal microbiome diversity.

Jessica R Allegretti, MD, MPH: Preventing Recurrent C Difficile with CP101

, investigators found etrasimod 2 mg results in improvements in quality of life for patients with moderate-to-severe 

A team, led by Michael V. Chiorean, MD, Swedish Medical Center, examined the effect of etrasimod on quality of life metrics.

Etrasimod is an oral, selective sphingosine 1-phosphate receptor 1, 4, and 5 modulatory that has shown promise inducing response and remission in the OASIS phase 2 trial of patients with moderate-to-severe ulcerative colitis.

Next, patients were offered to option to continue treatment in the open-label extension, where they received etrasimod 2 mg for up to an additional 34 weeks.

The OASIS study enrolled 109 adult patients with moderate-to-severe ulcerative colitis between 18-80 years. Each patient was randomized to receive either once-daily etrasimod 2 mg (n = 30), etrasimod 1 mg (n = 38), or placebo (n = 41).

The investigators evaluated quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ), which contains 32 items across 4 dimensions—bowel/systemic symptoms; social/emotional function. Each item is assessed on a 7 point scale.

The investigators collected data at baseline, week 12, and at the conclusion of treatment. They also evaluated changes from baseline in IBDQ scores based on the randomized treatment in the OASIS trial. At the final analysis there were 29 patients treated with etrasimod 2 mg, 38 patients in the 1 mg group, and 40 individuals in the placebo arm.

The IBDQ scores increased by 37.2 ± 40.4 points in the etrasimod 2mg group (

=0.07 vs placebo) and 30.9 ± 34.4 points in the etrasimod 1mg group (

=0.63 vs placebo) vs 24.4 ± 26.2 points in the placebo group at the week 12 mark.

Then at the conclusion of treatment the increases in scores in the etrasimod 2 mg group was maintained at 37.8 ± 44.9. On the other hand, IBDQ scores increased further in both the etrasimod 1 mg and placebo groups after the patients transitioned to etrasimod 2 mg (40.3 ± 43.5 and 41.7 ± 50.3, respectively).

At week 12, 73% of participants in the etrasimod 2 mg group achieved clinically meaningful improvements in IBDQ scores, compared to 61% in the etrasimod 1 mg group and 56% in the placebo group. At the conclusion of treatment, 71% of patients achieved clinically meaningful improvement.

“These data suggest a trend toward improved quality of life among adults with UC treated with etrasimod 2 mg,” the authors wrote. “Greater sample size is needed to confirm these results.”

Etrasimod Improves Quality of Life in Adults With Moderate-to-Severe Ulcerative Colitis: Results From the Phase 2 OASIS Trial and Open-Label Extension

Patients in the open-label extension of the OASIS study saw increases in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.

Internal Medicine

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Etrasimod Leads to Improvements in Quality of Life for Ulcerative Colitis Patients

RBX2660 is a a standardized, stabilized, investigational microbiota-based live therapeutic being studied for the treatment of C difficile infections. 

Paul Feuerstadt, MD: The Promise of RBX2660 for C Difficile

Patients with Crohn's disease often also suffer from kidney dysfunction.

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Ji Seok Park, MD: The Connection Between Crohn's Disease and Kidney Disease

Armand Butera is the assistant editor for 

. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining 

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Investigators reported that a higher proportion of participants in the abatacept group relapsed between weeks 12 and 40 compared to participants in the ustekinumab group.





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Abatacept Ineffective in Psoriasis Relapse Prevention 

This patient group had higher odds of death and longer lengths of hospital stays. 

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Liver Transplant Recipients With Heart Failure Require More Attention

Patients in both the ADVANCE and MOTIVATE studies achieved enhanced clinical response and endoscopic response.

Risankizumab Effective Treating Moderate-to-Severe Crohn’s Disease

To date, dupilumab is the only medicine to show clinically meaningful phase 3 results in this patient population, with regulatory fillings planned for 2022.





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Dupilumab Treatment for Eosinophilic Esophagitis Detailed in Phase 3 Data

Connor Iapoce is an assistant editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Data show women with AMI exhibited a more adverse cardiac risk factor profile and were more socially vulnerable than men in the US compared to Canada. 

Low Quality of Care for Acute Myocardial Infarction Observed in Young Adults 

Triamcinolone acetonide injectable suspension has been approved for administration via the suprachoroidal pathway—located in the back of the eye.

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FDA Approves Novel Pathway Injection for Uveitic Macular Edema

The rates of adverse events was similar across all 4 indications in comparison to the placebo group. 

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Safety Profile of Ustekinumab Favorable in IBD, Psoriatic Arthritis, Psoriasis

Hypertension rates were low in both ulcerative colitis and multiple sclerosis patients treated with ozanimod, regardless of concurrent SNRI/SSRI use. 

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Latest News

William Chey, MD, Explores Integrated Care for IBS Treatment at ACG 2021

Marla C. Dubinsky, MD: Measuring Urgency in Ulcerative Colitis

SER-109 Reduces Recurrence of C Difficile Infections

Jessica R Allegretti, MD, MPH: Preventing Recurrent C Difficile with CP101

Etrasimod Leads to Improvements in Quality of Life for Ulcerative Colitis Patients