All posts by Mary Jo Strobel

Medical Foods Advocates Needed

Advocacy, APFED Blog, What's New

We invite community members to join us in advocating for the Medical Nutrition Equity Act.

Congress needs to hear from you!

APFED is an active member of the Patients & Providers for Medical Nutrition Equity (PPMNE) coalition. PPMNE is coordinating a week of actions June 14-18, including virtual meetings with members of Congress on June 15. We must send the message to Congress that it’s time to pass the Medical Nutrition Equity Act.

Join us! Learn more and register by May 31: https://nutritionequity.org/speakup2021/

 

Research Updates from ACG 2020 Virtual Annual Scientific Meeting & Postgraduate Course

APFED Blog, Research, What's New

The annual scientific meeting of the American College of Gastroenterology took place online, Oct. 23-28, 2020.

The program included lectures, posters, and case studies specific to eosinophilic gastrointestinal diseases. Below is a brief summary of some of the research presented at the meeting, and press announcements. To view the eposters, visit the ACG Poster Hall.

 

Assessing the Diagnostic Journey, Burden of Disease, and Treatment Patterns in Patients With Eosinophilic Esophagitis in a Real World Setting
Poster # P0852

A retrospective observational cohort study assessing EoE diagnostic journey, burden of disease and treatment patterns was presented as a poster. The average age of the patients in the cohort was 24.2 and roughly 65% were male.

The authors concluded that generally, symptoms and medicine usage by patients with EoE increased after diagnosis. The most common signs and symptoms from this cohort included dysphagia, abdominal pain and gastroesophageal reflux disease. The most commonly used off-label medicine before was proton pump inhibitors.

Patients consulted with multiple specialists and had substantial health care resource utilization (more than half of the cohort had ER visits and nearly 1 in 5 had inpatient admission).

Ellodi Pharmaceuticals announces favorable Phase 2b results of APT-1011, an oral disintegrating tablet of fluticasone propionate
S0345

Ellodi Pharmaceuticals announced results of APT-1011 (fluticasone propionate oral disintegrating tablet) in a Phase 2b clinical study known as FLUTE that addresses the maintenance of remission following induction in Eosinophilic Esophagitis (EoE). All APT-1011 dose arms showed clinically meaningful and statistically significant achievement of histological remission with reduction of eosinophil counts in the esophageal mucosa, compared to placebo, at 12 weeks. This was accompanied by symptomatic improvement, as demonstrated by reduction in patient-reported disease symptoms, such as dysphagia. These improvements were maintained over 52 weeks of treatment. APT-1011 was generally well tolerated.
Read more.

Results from Prospective Prevalence Study Indicate that Eosinophilic Gastritis and Eosinophilic Duodenitis* May be Significantly Underdiagnosed
Poster # P2797

Allakos Inc., a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, announced results from a prospective study examining the rates of elevated eosinophil and mast cell levels in patients with chronic unexplained gastrointestinal symptoms or functional gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia. The results were presented at ACG as a poster authored by Dr. Kathryn Peterson of University of Utah, Dr. Robert Genta from Baylor College of Medicine; Drs. Amol Kamboj, Bhupinder Singh, and Henrik S. Rasmussen from Allakos; and Dr. Evan Dellon from University of North Carolina.
Among the findings, the researchers noted:
• 29% of patients entering the AK002 trial without an established diagnosis of EG/EoD were diagnosed with moderate-severe EG/EoD
• Most of the newly diagnosed EG/EoD patients had a previous history of GER/GERD, peptic ulcer disease, or a functional GI disorder
• Newly diagnosed patients had a similar symptom response to AK002 in ENIGMA as patients with an established diagnosis of EG/EoD
• Long-term treatment of AK002 in open label extension led to further improvement in symptoms and was generally well-tolerated

“These data suggest that EG/EoD may be more common than previously reported, and that EG/EoD should be considered in patients with chronic, moderate to severe GI symptoms,” the poster authors concluded. “Upper endoscopy with multiple gastric and duodenal biopsies may be indicated for patients with chronic nonspecific GI symptoms.”

*Eosinophilic duodenitis (EoD) is a newer and more specific term for eosinophilic gastroenteritis when the first part of the small bowel, the duodenum, is primarily involved.

View the Press Release

Phase 3 clinical trial post hoc analyses of Budesonide Oral Suspension (BOS) in patients EoE aged 11 to 55 years
Posters P0909 and P0878
Takeda Pharmaceuticals presented post hoc analyses from a 12-week, randomized, double-blind, placebo-controlled Phase 3 clinical trial that investigated the safety and efficacy of Budesonide Oral Suspension (BOS) in patients with eosinophilic esophagitis (EoE) 11 to 55 years of age.

BOS, also known as TAK-721, is Takeda’s oral suspension formulation of budesonide, currently under investigation for the treatment of EoE in adolescents and adults. Phase 3 clinical study results have shown TAK-721 to improve dysphagia symptoms, endoscopic appearance and reduce eosinophil counts in patients with EoE.

View the Press Release

Impact of Medication Compliance on Tissue Response to Proton Pump Inhibitor and Topical Steroid Combination Therapy in Children With EoE
Poster #P2529

A study presented at ACG sheds light on the relationship between pediatric adherence to PPI and topical corticosteroid therapy and the status of EoE and peak eosinophil count. Led by Dr. Girish Hiremath of Vanderbilt University Medical Center, the study authors also aimed to determine if any patient factors that were associated with complete compliance.
Among their findings peak eosinophil counts were found to negatively correlate with increasing medication compliance, and that the median peak eosinophil count was slightly lower in children with 100% compliance. They also reported that there was a significantly lower number of children with active EoE in the 100% compliance group (38%) versus those we had lower compliance (64%).

View Dr. Hiremath’s interview with HCPLive® about the research.

Registration for ACG 2020 is still open. For information on registration fees, visit https://acgmeetings.gi.org.

APFED and IES Announce Establishment of New Medical Codes for Eosinophil Diseases

Advocacy, APFED Blog, In the News, Press Releases, What's New

For Immediate Release


APFED Contact: Mary Jo Strobel, Executive Director, (713) 493-7749, mjstrobel@apfed.org


IES Contact: Kate Filipiak, Executive Director, (414) 276-6445, kfilipiak@eosinophil-society.org

The American Partnership for Eosinophilic Disorders and the International Eosinophil Society Announce Establishment of New Medical Codes for Eosinophil Diseases

(Atlanta, GA; Milwaukee, WI) — The American Partnership for Eosinophilic Disorders (APFED) and the International Eosinophil Society, Inc. (IES) are pleased to announce that new ICD 10-CM codes for subsets of eosinophil-associated diseases have been approved, thanks to the joint efforts of both organizations.

For nearly three years, APFED and IES have worked ambitiously to propose unique and distinct ICD-10-CM codes for subsets of eosinophilic diseases. The ICD-10-CM coding system is the U.S. version of the international classification system that groups related diseases and procedures for the purpose of reporting statistical information. The codes were approved by the ICD-10 Coordination and Maintenance Committee (C&M) and will take effect on October 1, 2020. The ICD-10 C&M is a Federal interdepartmental committee comprised of representatives from the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS).

NEW ICD-10-CM Codes for eosinophil-associated diseases:

  • Eosinophilic Asthma
  • Chronic Eosinophilic Pneumonia
  • Acute Eosinophilic Pneumonia
  • Lymphocytic Variant Hypereosinophilic Syndrome
  • Idiopathic Hypereosinophilic Syndrome
  • Other Hypereosinophilic Syndrome
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

“ICD codes are necessary for billing, insurance and medical records, and national statistics,” explained Kathleen Sable, a member of APFED Board of Directors who spearheaded the initiative on the organization’s behalf. “They are also extremely important to the patient community, because they enable researchers to better track these diseases and gauge prevalence and associated health care costs.”

Pursuing medical codes for eosinophil-associated disease is not a new venture for APFED. In 2008, the organization led successful efforts for the establishment of medical codes for eosinophilic gastrointestinal diseases, which greatly advanced research efforts and national health resource allocation in the U.S. for these diseases.

“It was an honor to work closely with the IES on this important initiative,” said Sable. “We are grateful for their expertise to help shape the justification for the codes, and their staunch commitment to advocacy.”

Dr. Paneez Khoury, an IES Board Member said, “This is a big win for health services research and an advance for patients with eosinophil associated disorders (EADs).” In 2018, a clinical working group of the IES identified the lack of codes for EADs as an unmet need for outcomes research. They subsequently highlighted the priority codes for adoption in the Journal of Leukocyte Biology(1).

“Broadening the spectrum of ICD codes related to these chronic debilitating conditions will further the understanding of their epidemiology, costs, and outcome,” said Dr. Florence Roufosse, President of the IES. “This is a key step towards improving management of EAD and patient care. The perseverance and advocacy of APFED was instrumental to making it happen!”

About the American Partnership for Eosinophilic Disorders (APFED)
The American Partnership for Eosinophilic Disorders (APFED) is a non-profit organization whose mission is to passionately embrace, support, and improve the lives of patients and families affected by eosinophil-associated diseases through education and awareness, research, support, and advocacy. https://apfed.org/

About the International Eosinophil Society, Inc. (IES)
The International Eosinophil Society (IES) is an organization of scientists and clinicians interested in the eosinophil. The Society was established to bring together scientists and medical experts from around the world who are engaged in research in the field of Eosinophil Biology and Eosinophil Disorders with a view to facilitating exchange of ideas and pursuing collaborative research projects dedicated to this inflammatory cell type and its role in diseases.
http://www.eosinophil-society.org/

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  1. Revisiting the NIH Taskforce on the Research needs of Eosinophil-Associated Diseases (RE-TREAD). Khoury P, et al. J Leukoc Biol 2018 Jul;104(1):69-83.

Share Your EGPA Perspectives

APFED Blog, What's New

APFED is working in partnership with a Medscape, the largest provider of continuing medical education to develop an accredited activity to educate physicians about eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss Syndrome. This educational program will also provide the learners with perspective of those who live with EGPA (or their caregivers).

We are currently seeking five people with EGPA (or their caregiver) to participate in a telephone interview with Medscape to capture their perspective to include in this program.

The person being interviewed will receive an honorarium for taking part in the interview.

Interviews will be conducted as soon as possible — please responded by February 28th.

To learn more and to complete a short questionnaire to indicate your interest, please visit this page: https://apfed.org/egpa-patient-perspective/

 

Highlights from ACG 2019

Announcements, APFED Blog, In the News, Research, What's New

This week, APFED was onsite at the American College of Gastroenterology’s 84th Annual Scientific Meeting and Postgraduate Course (ACG 2019) where 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 professional 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.


There were several exciting research posters presented throughout the meeting, including three in which APFED co-authored:

    • “Unmet Need for Additional Resources to Support Successful Transition of Care from Pediatric to Adult Providers for the Management of Eosinophilic Gastrointestinal Diseases,” presented by Gary Falk, MD, University of Pennsylvania
    • “Shared Decision Making in Eosinophilic Esophagitis Is Associated With Treatment Satisfaction but Is Inadequately Practiced,” presented by Joy W. Chang, MD, University of Michigan Medical Center
    • “Elucidation of Patient Motivators and Barriers to Pursuing Treatments for Eosinophilic Esophagitis,” presented by Joy W. Chang, MD, University of Michigan Medical Center

Other highlights from the meeting that are of interest to our community:

  • Evan Dellon, MD, from University of North Carolina at Chapel Hill, gave a lecture titled, “New Concepts in the Treatment of Eosinophilic” in which he reviewed updates in the epidemiology, nomenclature, diagnostic processes, and management of eosinophilic esophagitis (EoE).
  • Ikuo Hirano, MD, from Northwestern University in Chicago, presented data from the phase 3 trial of oral budesonide suspension (OBS) for the treatment of EoE. The study demonstrated its efficacy end points of symptom improvement and histologic efficacy.
    Read the press release from Takeda, the company investigating OBS for EoE.
    See below for a related interview with Dr. Hirano from MD Mag.
  • A session titled “Eosinophilic Esophagitis: Key Updates and Optimal Management” featured speakers Calies D. Menard-Katcher, MD (Children’s Hospital Colorado), who described the epidemiology and clinical presentation of pediatric EoE and discussed the transition of patients from pediatric to adult care; Nicholas J. Shaheen, MD (University of North Carolina at Chapel Hill), who discussed current diagnostic guidelines; and Kristle L. Lynch, MD (Perelman School of Medicine, University of Pennsylvania), who talked about the standard of care and emerging therapies.
  • Evan Dellon, MD, from University of North Carolina at Chapel Hill, presented a late-breaking abstract from a phase 2 trial of a potential therapy known as AK002 for eosinophilic gastrointestinal diseases. Allakos, the company developing this therapy is planning to initiate a Phase 3 study in EG and EGE and a Phase 2/3 study in EOE in 2020.
    See below for a related interview with Dr. Dellon from MD Mag.

The next annual meeting of ACG will take place Oct. 23-28 in Nashville, TN.