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
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.
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
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.