Eosinophilic esophagitis (EoE) is a rare inflammatory disease of the esophagus or food pipe, with symptoms that include difficulty swallowing food, acid reflux and heartburn, vomiting, and allergies. It affects children and adults and there is evidence that cases of EoE are increasing. Patients are often treated with drugs, called proton pump inhibitors, that reduce acid production in the stomach, or with steroids. However, these drugs may have serious side effects that can lead to other health conditions, such as cardiovascular disease and kidney disease. Other treatments include surgical procedures that may require admission to hospital.
The purpose of this study is to understand more about EoE and the impact it has on patients, including the symptoms and comorbid conditions they experience, the severity of disease, how these patients are currently managed including the treatments they receive and the side effects of treatment, as well as the long-term impacts of both the disease itself and treatment of the disease. In addition, it is important to understand the healthcare services used by patients with EoE and the economic costs of care. The results of the study will be used to inform how patients with EoE can be better managed and treated.
Objectives: EoE is a chronic inflammatory disease of the esophagus, characterized by esophageal dysfunction and eosinophil-predominant inflammation. There are limited data on clinical characteristics, treatments patterns, healthcare resource use and cost burden of EoE from a UK healthcare system perspective. The primary objectives are to: 1) describe demographic characteristics, clinical symptoms and comorbidities; 2) describe treatment patterns; 3) examine rates of adverse outcomes associated with standard EoE treatments; 4) assess healthcare resource utilization (HCRU) and costs associated with standard EoE treatments; 5) compare HCRU and costs for EoE patients with those for a non-EoE general population cohort.
Methods: This observational, retrospective cohort study will include all paediatric and adult patients in the CPRD with a diagnosis of EoE during the study period January 2014 to October 2020 (incident and prevalent cases). Primary exposures are incident EoE diagnosis (objectives 1, 2, 5), prevalent EoE diagnosis (objective 1, 5) and treatment with proton pump inhibitors, topical and/or corticosteroids (objectives 3, 4). The following outcomes will be assessed: demographic and clinical characteristics, comorbidities and disease severity (objective 1), drug treatments, dietary therapy and procedures (objective 2); drug-related adverse outcomes (objective 3); all cause and EoE-specific HCRU and costs (objectives 4, 5).
Data from linked CPRD, HES and ONS mortality data will be analysed. Descriptive analyses will be used to assess different exposure groups. Time to event and multivariable analyses will be conducted to assess associations between different drug therapies and incident adverse outcomes. HCRU will be applied to NHS cost data and analysed using generalized estimating equations (GEE) to estimate all-cause and EoE-associated total costs.
Intended benefits: The study results contribute to filling the evidence gap on characteristics, treatment patterns, adverse outcomes, HCRU and costs of patients diagnosed with EoE in England and could support improvements in the management of these patients.
The primary outcomes are as follows:
Primary objective 1: demographic characteristics; clinical symptoms; comorbidities; disease severity
Primary objective 2: drug therapies; investigative and monitoring procedures; treatment procedures; dietary therapies.
Primary objective 3: proton pump inhibitor-related adverse outcomes; corticosteroid-related adverse outcomes.
Primary objectives 4 and 5: annualised all-cause healthcare resource utilization and costs; annualised EoE-specific healthcare resource utilization and costs.
The exploratory outcomes are as follows:
Exploratory objective 1: EoE symptom onset.
Exploratory objective 2: adequate disease control; poor disease control.
Exploratory objective 3: annualised all-cause healthcare resource utilization and costs; annualised EoE-specific healthcare resource utilization and costs.
Ekaterina Maslova - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Julia Langham - Corresponding Applicant - Maverex Ltd
Mihail Samnaliev - Collaborator - Maverex Ltd
Nina Embleton - Collaborator - Maverex Ltd
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data