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

The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.

Study Overview

• Status: Completed
• Conditions: Hypereosinophilic Syndrome (HES)
• Intervention / Treatment: Other: no intervention

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02140
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Syndrome; Hypereosinophilic Syndrome
• Other Study ID Numbers: D3254R00004