All posts by Mary Jo Strobel

2022 Annual Meeting of the American College of Gastroenterology

APFED was onsite at the American College of Gastroenterology’s (ACG) Annual Scientific Meeting and Postgraduate Course which took place in Charlotte, NC, Oct. 21-26. Attendees from around the world gathered to learn the latest scientific advances in gastrointestinal research and treatment of digestive diseases.

APFED had a table in the exhibit hall to offer clinicians with resources to increase their understanding of the latest in diagnostics and treatments of these conditions, as well as educational material to share with their patients.

Pictured right: APFED executive director (center) with team members from Ellodi Pharmaceuticals. Ellodi is developing APT-1011, and investigational drug designed to deliver  fluticasone propionate to the esophageal mucosa as a potential therapy for EoE. 
Pictured left: APFED had a booth in the exhibit hall to provide clinicians with patient-friendly information about eosinophil-associated diseases and professional resources. 

Below are a few highlights from research abstracts presented at the meeting.

  • Results from KRYPTOS, a Phase 2/3 Study of Lirentelimab (AK002) in Adults and Adolescents With EoE was presented. While lirentelimab was effective in safely reducing histologic disease activity in most patients, but especially adolescents, with eosinophilic esophagitis (EoE), it did not meet the Dysphagia Symptom Questionnaire symptom co-primary endpoint, although in adolescents there was a trend in DSQ response over placebo. Learn more.
  • A poster that APFED co-authored, entitled “High Burden of Disease and Associated Costs for Eosinophilic Gastrointestinal Diseases: Results From an Online Patient-Centered Research Network” was presented. The findings showed that patients with non-EoE EGIDs experience high healthcare burdens, frequent medical care (average of 1 heath care encounter/month) and significant out-pocket costs (averaging $1,000/year). Learn more.
  • Dr. Evan Dellon from University of North Carolina at Chapel Hill presented an oral abstract entitled “Dupilumab Improves Clinical, Symptomatic, Histologic, and Endoscopic Aspects of EoE up to 24 Weeks: Pooled Results From Parts A and B of Phase 3 LIBERTY-EoE-TREET.” It was noted, “The findings were that the pooled efficacy and safety data for parts A and B of the phase 3 trial of Dupilumab are consistent with the results of the individual parts of the study that were previously reported, and which led to the drug being approved for EoE.” Learn more.
  • Dr. Amrit K. Kamboj from Mayo Clinic in Rochester, MN presented a plenary session entitled, “Development and Validation of a Clinical Tool to Identify Patients Who Do Not Need Biopsies When Eosinophilic Esophagitis Is Suspected” describing work to develop and then validate a predictive model that accurately identifies patients with “a low likelihood of EoE where unnecessary biopsies can be avoided, potentially resulting in cost and time savings, and lower risk.” Learn more.
  • A poster entitled “Hospitalization Outcomes and Racial Disparities in Eosinophilic Esophagitis Patients: An Analysis of the National Inpatient Sample Data from 2016 to 2019” was presented. The findings indicated that “patients from African American descent admitted [into the hospital] with EoE appear to have similar mortality as compared to white patients but higher morbidity in the form of longer [length of stay] and longer time to EGD.” Learn more.

 

Other research abstract titles of interest are below. You may access the poster presentations here.

    • Esophageal Cytology Collection Device for Assessment of Esophageal Eosinophilia in Eosinophilic Esophagitis: Real World Experience
    • Co-Localization of Immunoglobulin G4 (IgG4) and Milk Proteins Is Associated With Eosinophilic Esophagitis Disease Activity\
    • Dupilumab Reduces the Emotional and Dysphagia-Related Impacts of Eosinophilic Esophagitis to Improve Health-Related Quality of Life
    • Health Care Resource Utilization and Costs Among Eosinophilic Esophagitis Patients in the United States
    • Opportunities for Virtual Care in Eosinophilic Esophagitis: Real-World Dietary Therapy Practice
    • Esophageal Cytology Collection Device for Assessment of Esophageal Eosinophilia in Eosinophilic Esophagitis: Real World Experience
    • The Epidemiology of Inflammatory Bowel Disease in Eosinophilic Esophagitis in the United States: Results From a Population-Based National Study
    • Physician-Documented Symptoms and Treatment Among Patients With Eosinophilic Esophagitis in the United States: Evidence From Real World Clinical Practice
      Characteristics of and Healthcare Cost Drivers Among U.S. Patients With Eosinophilic Esophagitis With High versus Non-High All-Cause Costs: An Analysis of Insurance Claims Data
    • Provider Beliefs, Practices, and Perceived Barriers to Dietary Elimination Therapy in Eosinophilic Esophagitis
    • Burden of Eosinophilic Esophagitis 2016-2019: NIS-Based Retrospective Analysis
    • A Retrospective Study on the Geographic Trends of Eosinophilic Esophagitis (EoE) in the United States
    • Examining the Diagnostic Pattern of Eosinophilic Esophagitis Among Medicaid Enrollees in the Deep South U.S.
    • Prevalence of Eosinophilic Esophagitis in Hispanic Children and Young Adults in South Florida
    • Diagnostic Delay and Misdiagnosis of Non-Esophageal Eosinophilic Gastrointestinal Diseases
    • Effect of Proton Pump Inhibitor Treatment in “PPI Non-Responsive” Patients With Eosinophilic Esophagitis
    • The Eosinophilic Esophagitis Patient With Multiple Atopic Conditions: Clinical Characteristics and Treatment Response to Topical Steroids
    • High Burden of Disease and Associated Costs for Eosinophilic Gastrointestinal Diseases: Results From an Online Patient-Centered Research Network
    • Clinical Features and Treatment Response to Topical Steroids in Ethnic and Racial Minority Patients With Eosinophilic Esophagitis
    • Nationwide Seasonal Variation in Food Impaction in Patients with Eosinophilic Esophagitis\
    • A Real World Study of Cumulative Steroid Burden in Patients With Newly Diagnosed Eosinophilic Esophagitis
    • 10-Year Epidemiological Trends of Eosinophilic Gastritis and Eosinophilic Gastroenteritis
    • Gene Expression and Pathway Analyses Reveal Distinctions Between Eosinophilic Esophagitis Pre and Post Treatment With Glucocorticoids
    • Long-Term Follow-Up of Esophageal Strictures in Eosinophilic Esophagitis Using Structured Esophagram Protocol
    • Markedly Increased Prevalence of Eosinophilic Esophagitis in Patients With Atopic Diseases in a U.S. Veteran Population
    • Clinicopathological Features and Gastric Motor Functions in Patients With Eosinophilic Gastroenteritis: A Retrospective Single Center Audit

2022 Annual Meetings: ATS and DDW®

American Thoracic Society and Digestive Disease Week® 2022

APFED attended two large medical conferences in California in May, both of which offered programming for health care providers to learn the latest in diagnostics, treatment, and research advances for eosinophil-associated diseases. In addition to attending sessions, we met with clinicians and researchers to raise awareness of these conditions, and to collaborate on projects to address the unmet needs and improve patient care.

Below are session and research highlights from the meeting.

American Thoracic Society

May 13-18, Online + San Francisco

The annual meeting of the American Thoracic Society is designed for professionals in the field of pulmonary, critical care. Programming for providers included diagnosis and management of eosinophilic asthma, hypereosinophilic syndromes, and eosinophilic granulomatosis with polyangiitis (EGPA).

Sessions offered discussion on optimizing the use targeting eosinophils in severe asthma, of biologic therapies to better manage moderate-to-severe asthma, pathophysiology and clinical presentation of severe asthma, its comorbidities and the burden of oral corticosteroids; and a special session specific to EGPA and HES that raised awareness of these conditions among clinicians and highlighted the role of multidisciplinary collaboration to facilitate diagnosis and management.

Among research highlights from the meeting are:

  • Results from the Phase 3 NAVIGATOR trial show half of patients with severe, uncontrolled asthma improved with Tezepelumab.
  • Results from the LIBERTY ASTHMA TRAVERSE study showed persistent reductions in oral corticosteroid (OCS) use in patients with severe, OCS-dependent asthma treated with dupilumab.
  • Retrospective study by researchers in Japan that showed mepolizumab and benralizumab are highly effective for patients with severe eosinophilic asthma.

 

Digestive Disease Week® (DDW)

May 21-24, Online + San Diego

DDW® brings together professionals in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. There were several sessions for health care providers to learn the clinical manifestations of eosinophilic gastrointestinal disease, how to diagnose EGID, and treatment options to manage symptoms.

Several research posters for EGID were presented during the meeting, including those that looked at disease burden and healthcare resource utilization, potential risk factors associated with EGID development such as environmental contaminants and early life factors, treatment impacts and comparisons, and the transcriptional and cellular landscape in EGIDs.

 

APFED Research Collaborations Presented as Posters at DDW®

This survey was completed by those registered in the EGID Partners patient registry (EgidPartners.org), which is an online patient-powered research network. “We identified preliminary associations between certain early life factors and non-EoE EGIDs including pregnancy complications, NICU admission and antibiotics in infancy.” More research is needed into the role that early life exposures play in non-esophageal EGIDs, and its overlap with EoE.

 

  • Perceptions of COVID-19 in the Eosinophilic Esophagitis Population. This survey among of APFED’s membership was conducted prior to emergency use authorization of a COVID vaccine. Results show that “COVID-19 has led to anxiety and interruptions in care in the EoE population,” and that “Providers should address anxiety, counsel about the vaccine, and create care plans that decrease pandemic-related delays”.

 

  • Hashing out current social media use in #eosinophilic_esophagitis. In this first study to ever look at social media usage in the context of EoE, the authors found that an overwhelming majority of patients and caregivers use various social media platforms to learn about the condition, however, those who use social media for this purpose don’t have a higher knowledge of the disease. People who did not use social media to learn about EoE cited distrust of content as the largest barrier to use.”

 

APFED Recognizes Outstanding EGID Abstracts at Disease Week DDW®

APFED partnered with the AGA (American Gastroenterological Association) to offer abstract awards for exceptional abstracts on Eosinophilic GI Diseases that were presented at Digestive Disease Week DDW®. The awards support the recipients work to present oral or poster presentations at the meeting, and stimulate additional interest in eosinophilic gastrointestinal disease research careers.

  • Takeo Hara, MD, PhD, Children’s Hospital of Philadelphia, PA
    Title: Adenosine supports epithelial homeostasis and autophagy in eosinophilic esophagitis.
    Summary: This study examined the effect of CD73-derived adenosine (an important chemical in the cell) in the lining of the esophagus. Dr. Hara found that by adding adenosine to cells may ultimately improve the lining of the esophagus.  His team concluded that adenosine supplementation may offer a new therapeutic approach for EoE.
  • Michael Wang, BS, Duke University School of Medicine, Durham, NC
    Title: The importance of routine gastric and duodenal biopsies on follow-up endoscopy for patients with eosinophilic esophagitisSummary: Through a retrospective study, they found that routine gastric and duodenal biopsies during endoscopy (GDB) in patients with EoE, resulted in almost half of abnormal GDBs with a change of therapy. Additionally, almost 1 in 12 of patients with EoE were reclassified as eosinophilic gastritis or eosinophilic duodenitis.
  • Melissa Nelson, MD, Baylor University Medical Center, Dallas, TX
    Title: il-13/il4rα Signaling increases tension in human circular esophageal smooth muscle through increases in expression and phosphorylation of cpi-17: Potential contribution to reduced esophageal distensibility in EoE
    Summary:  Most studies have examined the role of cell signaling pathways in the mucosal layer of the esophagus and its role in EoE.  This study found the cellular signaling pathways in the smooth muscle layer of the esophagus that could be affected by EoE. Likewise, these pathways could be future therapeutic targets.

 

 

Dupixent® Receives FDA Approval to Treat EoE in People Ages 12 and Older

Dupixent® Receives FDA Approval to Treat EoE in People Ages 12 and Older

Injection is the first indicated treatment for EoE

 

May 21, 2022:  APFED (The American Partnership for Eosinophilic Disorders) is pleased to share the exciting news that the first treatment for eosinophilic esophagitis (EoE) has been approved by the U.S. Food and Drug Administration (FDA) during National Eosinophil Awareness Week.

The FDA approved Dupixent® (dupilumab), jointly developed by pharmaceutical companies Sanofi and Regeneron, for treatment of adults and children 12 years and older with EoE. This chronic inflammatory condition is characterized by the presence of white blood cells called eosinophils in the esophagus.  Eosinophils cause inflammation in the esophagus and damage to the tissue, leading to symptoms of difficulty swallowing, food getting stuck in the esophagus, pain, vomiting, and malnutrition.  Treatments to date have included eliminating allergy-causing food from the diet, proton pump inhibitors, and off-label use of swallowed steroids.

APFED congratulates Sanofi and Regeneron for their commitment to developing Dupixent® and for funding the LIBERTY EoE TREET clinical studies, which demonstrated significant decrease of the number of eosinophils in the esophagus as well as improved symptoms in patients with EoE treated with Dupixent® compared to placebo. APFED would also like to thank the FDA for its priority review for this breakthrough treatment that has the potential to improve the lives of people living with EoE, and to all those who selflessly participated in research and clinical trials so that developments such as dupilumab could advance.

“The fact that this news comes during National Eosinophil Awareness Week is incredible,” said APFED’s Executive Director Mary Jo Strobel. “Fifteen years ago, APFED set out to establish an official awareness week, which was formally recognized by the U.S. House of Representatives through House Bill 296. The purpose of the week is to create awareness and educate the general public and the medical community about eosinophil-associated diseases. With greater awareness, a supportive community develops, and the need for research and improved therapies is amplified. The FDA’s decision to grant approval to Dupixent® to treat EoE is very welcome news to our community.”

“APFED was founded in 2001 with the mission to support patients and families affected by EoE and other eosinophil-associated disorders by educating patients, providers, and the public about these conditions, advocating for patients’ needs, and supporting research,” said APFED’s President Dr. Wendy Book. “Since 2006, thanks to community donations, APFED has awarded nearly $2 million in grants to investigators to advance research in eosinophilic disorders through a rigorous application process.” Many of the research projects APFED funded involved research of the immune and inflammatory pathways involved in the development of EoE. Having the pathways to inflammation identified helps guide potential future therapies.

Dr. Prad Tummala, Chairman of APFED’s Board of Directors, adds, “APFED hopes that the current success of Dupixent® is the first of many therapies that will be discovered as a result of ongoing research in the field of eosinophilic disorders. APFED depends on the generosity of donors to continue to support research and hopes that this exciting announcement of the first FDA-approved therapy indicated for EoE treatment will inspire more members of the community to donate to research, as it demonstrates the value of investing in it.”

Ryan Piansky, a young adult who was diagnosed with EoE in early childhood, shares the excitement patients and families feel about the FDA approval. “APFED has always provided hope to patients and families living with eosinophilic diseases. As a patient with EoE who met with members of Congress to help pass the National Eosinophil Awareness Week resolution, I am thrilled to hear of the first FDA approved treatment indicated for EoE. APFED’s commitment to finding treatments for these rare diseases provides a beacon of hope.”

To learn more about APFED’s HOPE on the Horizon Research Program and to make a donation, please visit apfed.org.

Read More

  • FDA Press Release: FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder
  • Sanofi Press Release: FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis

2022 Annual Meeting of AAAAI

AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. AAAAI has more than 7,000 members around the globe.

APFED attended the AAAAI 2022 annual meeting held in Phoenix, AZ, Feb. 25-28 as an invited speaker. We also awarded two awards for the best research abstracts for EGID, attended advocacy meetings, and had a booth in the exhibit hall where we could share patient friendly material with clinicians.

Breakthroughs in Understanding and Treating EGID

An all-day symposium to present EGID information and research was held on February 24. The program was organized by the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) and the International Gastrointestinal Eosinophil Researchers (TIGERS).

Attendees learned information about the diagnosis, epidemiology, and the role of the allergy in EGID, and pipeline treatments. There was also discussion on research that is shedding light onto cellular and molecular processes with these conditions, monitoring the progression of EGID through time, dietary aspects, the patient experience, and new therapies and treatments on the horizon.

As an active member of CEGIR, APFED’s Executive Director, Mary Jo Strobel, gave a presentation during this symposium to highlight ways that doctors and patients can work in partnership with one another to advance education, awareness, advocacy and research, as well as resources available to help people who have EGID.

There were presentations and discussions regarding EGIDs and associations with allergic disease.  EoE is highly associated with allergic diseases and elimination diets seem to work for many with EoE. On the other hand, there are differences at the cellular and molecular level between EoE and other EGID, which may make dietary therapy less successful.

Attendees were also informed of recent international consensus surrounding what subsets of eosinophilic gastrointestinal diseases are called for both clinical and research purposes.

Throughout AAAAI sessions, scientists discussed current knowledge and research of the etiology, pathology, and genetic and environmental factors that might affect the development of EoE, as well as data related to therapies in various stages of clinical trial for eosinophil-associated disease.

Dr. Benjamin Wright, an APFED HOPE Pilot Grant recipient who is studying the association of environmental factors and its impact on cells involved in EoE, presented his latest findings in the “Featured Poster Session” at AAAAI. His poster presentation was “Oral Detergent Exposure Induces Eosinophilic Inflammation in the Esophagus.” These early findings show that an ingredient in detergents, called SDS, reduces the functionality of epithelial cells and may be a factor to the development of EoE.

Special Committees

APFED attended special interest EGID Task Force committee meeting to participate in discussions on ways the medical community can support those with eosinophil-associated disease, and also met with patient advocacy organizations serving people with allergic conditions to discuss advocacy and policy work, and aligning initiatives to help our communities, including the Medical Nutrition Equity Act and communicating patient needs and perspectives to the FDA.

2022 AAAAI/APFED Best Abstract on EGIDs Awards

APFED offered two $750 awards to recognize outstanding research abstracts on eosinophilic gastrointestinal disease presented at the AAAAI meeting this year. The awards are intended to help defray travel costs to the meeting so that the researchers may present their findings to their peers. Abstract award winners may go on to successfully compete for grants from APFED or from other funding mechanisms.

  • Marc E. Rothenberg, MD PhD FAAAAI Cincinnati Children’s Hospital Medical Center “Dupilumab Improves Clinical and Histologic Aspects of Disease in Adult and Adolescent Patients with Eosinophilic Esophagitis at Week 24: Results from Part B of the 3-Part LIBERTY EoE TREET Study”
  • Gencer Kurt, MD Aarhus University Hospital “Perinatal Factors Increase Risk of Eosinophilic Esophagitis – A Nationwide Case Control Study”

The awards were made possible thanks to the generous community donations to APFED’s HOPE on the Horizon Research Program.

Additional highlights surrounding presentations and research presented at AAAAI will be published in the Spring 2022 issue of EoSolutions newsletters for APFED subscribers.

International Consensus Recommendations EGID Nomenclature

International consensus surrounding what subsets of eosinophilic gastrointestinal diseases (EGIDs) should now be called for both clinical and research purposes was recently published in the Journal of Gastroenterology and Hepatology.

Eosinophilic gastrointestinal disease (EGID) will continue be the umbrella term for eosinophilic inflammation in the GI tract when there is not another known cause.

The consensus indicated more specific terms should be used to describe has previously been called “eosinophilic gastroenteritis.”

These changes to the terms used to describe subsets of patients and conditions help characterize the specific areas of the GI tract that are affected. These include:

  • Eosinophilic Gastritis (EoG) = stomach
  • Eosinophilic Enteritis (EoN) = small bowel
  • Eosinophilic Colitis (EoC) = colon

“Eosinophilic Gastroenteritis” was previously used as a “catch-all” term for eosinophilia that was found in the stomach and/or small intestine, and should not be primarily used, with the terms above being used instead. The new international consensus also more granularly identifies areas of the GI tract that are affected:

  • Eosinophilic Duodenitis (EoD) = duodenum
  • Eosinophilic Jejunitis (EoJ) = jejunum
  • Eosinophilic Ileitis (EoI)  = ileum

This groundbreaking publication was spearheaded by CEGIR, a federally-funded research consortia in which APFED is a member.