Last updated: 06/05/2025 04:40:21

Mepolizumab Impact on End-Organ Manifestations in Participants with Eosinophilic granulomatosis with polyangiitis (EGPA) or Hypereosinophilic Syndrome (HES)

GSK study ID

221044

Clinicaltrials.gov ID

Not applicable

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Recruitment complete

Recruitment complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: Mepolizumab Impact on End-Organ Manifestations in Patients with EGPA or HES

Trial description: This study explores how mepolizumab impacts organ health in participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES), diseases that can cause organ damage. Using already collected healthcare data, researchers will compare mepolizumabs effects with other treatments like corticosteroids and immunosuppressants. The study seeks to understand if mepolizumab reduces organ problems over time. Participants are selected based on their health records, focusing on those who consistently use mepolizumab or other standard care medications. The study will not involve direct participant interactions, ensuring privacy and confidentiality throughout the analysis. For individuals with EGPA who are using mepolizumab, the index date is set as the first dispensing of mepolizumab following December 12, 2017, which is when the FDA approved mepolizumab for EGPA treatment. For those using Standard of Care (SOC) medications, the index date is marked by the initial dispensing or administration of any SOC medication post-December 12, 2017, provided there are at least two medical or pharmacy claims for the same SOC medication within six months from the index date. For participants with HES who are taking mepolizumab, the index date is the first dispensing of mepolizumab after October 1, 2020, coinciding with the introduction of the HES ICD-10 code. For SOC medication users in this group, the index date is the first dispensing or administration of any SOC medication after October 1, 2020. These participants must also have at least two medical or pharmacy claims for the same SOC medication within six months from their index date.

Primary purpose:

Not applicable

Trial design:

Not applicable

Masking:

Not applicable

Allocation:

Not applicable

Primary outcomes:

Percentage of Participants with End Organ Dysfunction (EOD) Among United States (US) Participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Treated with Mepolizumab versus SOC medications

Timeframe: Up to 12 months post Index date (End of observation)

Rate of EOD Among US Participants with EGPA Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Secondary outcomes:

Percentage of Participants with EOD Among US Participants with HES Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Rate of EOD Among US Participants with HES Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Baseline Characteristics Among US Participants with EGPA Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Baseline Characteristics Among US Participants with HES Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Percentage of Participants Categorized by EOD Status Change Among US Participants with EGPA Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Percentage of Participants Categorized by EOD Status Change Among US Participants with HES Treated with Mepolizumab versus SOC

Timeframe: Up to 12 months post Index date (End of observation)

Interventions:

Not applicable

Enrollment:

Not applicable

Primary completion date:

2025-22-08

Observational study model:

Cohort

Time perspective:

Retrospective

Clinical publications:

Not applicable

Medical condition

Eosinophilic Granulomatosis with Polyangiitis

Product

mepolizumab

Collaborators

Not applicable

Study date(s)

May 2025 to August 2025

Type

Observational

Phase

Not applicable

Participation criteria

Sex

Female & Male

Age

12+ years

Accepts healthy volunteers

Yes

Inclusion Criteria for Eosinophilic granulomatosis with polyangiitis (EGPA)
Greater than or equal to (>=)1 diagnosis code for EGPA International Classification of Diseases 10th Revision Clinical Modification (ICD-10-CM M30.1) during the participant identification period of 01 July 2017 to 31 September 2023 9 (or latest available data)

Inclusion and exclusion criteria

Inclusion criteria:

Inclusion Criteria for Eosinophilic granulomatosis with polyangiitis (EGPA)

Greater than or equal to (>=)1 diagnosis code for EGPA International Classification of Diseases 10th Revision Clinical Modification (ICD-10-CM M30.1) during the participant identification period of 01 July 2017 to 31 September 2023 9 (or latest available data) Inclusion Criteria for Mepolizumab Users (EGPA)
Initiated mepolizumab (any dose) from 01 July 2017 to 31 September 2023 after EGPA diagnosis o The index date will be the first record/date observed for Mepolizumab
>=2 medical or pharmacy claims for any dose (e.g. 100 milligrams [mg] or 300 mg) mepolizumab within 6 months (during the Landmark period) following the index date will be required
>=6 months of continuous health plan enrolment prior to the index date (i.e., baseline period)
>=12 months of continuous health plan enrolment after the index date
>=18 years of age at the index date Inclusion Criteria for Chronic Standard of care (SOC) Users (EGPA)
Evidence of other chronic SOC medication use (e.g., corticosteroids, immunosuppressants, respiratory medications, and other biologics) will be identified
Chronic SOC use will be defined as >=6-months of greater than (>)7.5 mg prednisone equivalent and/or >=2 records of immunosuppressants or other disease-modifying antirheumatic drugs (DMARDs) within 6-months of index date (during Landmark period) o The earliest record and date of this continuous use period of Systemic corticosteroids (SCS) and/or immunosuppressants or DMARDS will be defined as the index date
>=6 months of continuous health plan enrolment prior to the index date (i.e., baseline period); a grace period of 30 days will be considered
>=12 months of continuous health plan enrolment after the index date
>=18 years of age at the index date Inclusion Criteria for Hypereosinophilic Syndrome (HES)
>=1 diagnosis code for HES (ICD-10-CM D72.11x) during the participant identification (ID) period of 01 October 2020 to 31 September 2023 (or latest available data) Inclusion Criteria for Mepolizumab Users
Initiated mepolizumab (any dose) from 01 October 2020 to 31 September 2023 after HES diagnosis (The index date will be the first record/date observed for Mepolizumab)
>=2 medical or pharmacy claims for any dose (e.g. 100 mg or 300 mg) mepolizumab within 6 months following the index date will be required
>=6 months of continuous health plan enrolment prior to the index date (i.e., baseline period)
>=12 months of continuous health plan enrolment after the index date
>=12 years of age at the index date Inclusion Criteria for Chronic SOC Users (HES)
Evidence of other chronic SOC medication use (e.g., corticosteroids, immunosuppressants, respiratory medications, and other biologics) will be identified
Chronic SOC use will be defined as >=6-months of >7.5 mg prednisone equivalent and/or ≥2 records of immunosuppressants or other disease-modifying antirheumatic drugs (DMARDs) within 6-months of index date (during Landmark period) o The earliest record and date of this continuous use period of SCS and/or immunosuppressants or DMARDS will be defined as the index date
>=6 months of continuous health plan enrolment prior to the index date (i.e., baseline period); a grace period of 30 days will be considered
>=12 months of continuous health plan enrolment after the index date
>=12 years of age at the index date Exclusion Criteria for Participants with EGPA
Participants with missing demographic characteristics including age and sex will be excluded. Missingness for other characteristics including race/ethnicity, insurance type/plan, and geographic region will also be reviewed and described. Exclusion Criteria for Chronic SOC Users (EGPA)
>=1 medical or pharmacy claim for mepolizumab Eligibility Criteria for Mepolizumab Users (HES)
Participants with missing demographic characteristics including age and sex will be excluded. Missingness for other characteristics including race/ethnicity, insurance type/plan, and geographic region will also be reviewed and described Exclusion Criteria for Chronic SOC Users (HES)
>=1 medical or pharmacy claim for mepolizumab

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status

Recruitment complete

Actual primary completion date

Not applicable

Actual study completion date

Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable

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