TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.

Detailed Description
-----------------
Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.

Official Title
-----------------
TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause

Conditions
-----------------
Hypereosinophilic Syndrome (HES)

Intervention / Treatment
-----------------
* Other: no intervention
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis record of HES (ICD-10-CM D72.11) anytime during 01 October 2020 to 30 June 2023 At least 12 months of patient insurance record prior to first HES record. Exclusion Criteria: Any mutation in PDGFRA, PDGFRB or FGFR1 genes (to exclude clonal HES). History of BCR-ABL tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal HES) History of myeloid leukemia, myeloproliferative disorder, myelodysplastic disorder, myelomonocytic leukemia, acute erythroid leukemia, acute megakaryoblastic leukaemia, acute panmyelosis with myelofibrosis, and other specified leukaemias (to exclude reactive HES) History of helminthiasis or use of anthelmintic medication (to exclude reactive HES) History of autoimmune disease (to exclude reactive HES) History of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive HES)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anti-IL-5/IL-5R therapy<br>Patients initiated anti-IL-5/IL-5R therapy | Other: no intervention<br>* not applicable, this is an observational retrospective data analysis study; no interventions in the study<br>|
| other therapies<br>Patients initiated other therapies. | Other: no intervention<br>* not applicable, this is an observational retrospective data analysis study; no interventions in the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities prior to first HES record | To describe clinical characteristics of patients with HES. | 01 October 2020- the most recent data available in 2023 | 
| Other eosinophilic conditions | To describe the clinical characteristics of HES patients. | 01 October 2020- the most recent data available in 2023 | 
| Organ system with HES signs and/or symptoms | To describe the disease burden of HES. | 01 October 2020- the most recent data available in 2023 | 
| Number of organ systems with HES signs and/or symptoms | To describe the disease burden of HES. | 01 October 2020 - the most recent data available in 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics | To describe the demographic characteristics of HES patients and sub-group analysis patients. | 01 October 2020- the most recent data available in 2023 | 
| Patient journey in diagnostic phase | To describe the patient journey in diagnostic phase and in sub-group analysis. | 01 October 2020 - the most recent data available in 2023 | 
| HES and non-HES therapies & treatment pattern | To describe the treatment pattern of HES patients and sub-group analysis patients. | 01 October 2020 - the most recent data available in 2023 | 
| Clinical outcomes | To describe clinical outcome pre and post index date and compare between biologics and patients treated with anti-IL-5/IL-5Rα therapies. | 01 October 2020 - the most recent data available in 2023 |