Last updated: 01/06/2025 08:00:24

Impact of treatment with mepolizumab on participants with EGPA

GSK study ID
217460
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Mepolizumab among Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA): A Real-World Assessment of Corticosteroid Use, EGPA Relapse, and Asthma Exacerbations in the US
Trial description: The objective is to evaluate the real-world steroid sparing trends after mepolizumab initiation among participants with EGPA who received 2 or more mepolizumab treatments in the United States (US) using data from Komodo Health’s comprehensive database. The study will evaluate the Oral Corticosteroids (OCS) use among participants with EGPA before and after mepolizumab initiation using a pre/post study design. Mepolizumab treatment patterns will also be described. Participants with asthma initiating mepolizumab treatment will be identified and required to have continuous enrollment at least 12 months prior to initiating mepolizumab treatment and at least 12 months following initiation of treatment.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants receiving greater than or equal to (≥) 1 OCS dispensing

Timeframe: 12 months pre- and post- index date

Number of pharmacy claims for an OCS medication

Timeframe: 12 months pre- and post- index date

Average daily dose of OCS per dispensing

Timeframe: 12 months pre- and post- index date

Average daily dose of OCS during the baseline/observation period

Timeframe: 12 months pre- and post- index date

Number of participants with continuous OCS use for 6 months

Timeframe: 12 months pre- and post- index date

Number of participants with continuous high dose (>12 mg/day) OCS use for 6 months

Timeframe: 12 months pre- and post- index date

Number of participants with chronic OCS use for 6 months

Timeframe: 12 months pre- and post- index date

Rate of OCS bursts

Timeframe: 12 months pre- and post- index date

Secondary outcomes:

Number of participants with mepolizumab administrations

Timeframe: 12 months post-index date

Total treatment duration with mepolizumab

Timeframe: 12 months post-index date

Number of participants with other EGPA medications

Timeframe: 12 months post-index date

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2023-09-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Sameer K Mathur, Jared Silver, Sean D MacKnight, Ana Urosevic, Cristina Martinez, Kaixin Zhang, François Laliberté, Arijita Deb. Real-world mepolizumab treatment in eosinophilic granulomatosis with polyangiitis reduces disease burden in the United States. Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2024-Nov-14; PMID: 39549986 DOI: 10.1016/j.anai.2024.11.004
    Medical condition
    Churg-Strauss Syndrome, Eosinophilic Granulomatosis with Polyangiitis
    Product
    mepolizumab
    Collaborators
    NA
    Study date(s)
    April 2023 to May 2023
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Greater than or equal to (≥) 2 medical or pharmacy claim for mepolizumab between December 12, 2017 (i.e., the approval date of mepolizumab for EGPA) and March 1, 2019
    • ≥1 subsequent medical or pharmacy claim for mepolizumab within 6 months following the index date
    • ≥1 medical or pharmacy claim for mepolizumab any time before the index date
    • ≥1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, or dupilumab during the baseline period or on the index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Greater than or equal to (≥) 2 medical or pharmacy claim for mepolizumab between December 12, 2017 (i.e., the approval date of mepolizumab for EGPA) and March 1, 2019
    • ≥1 subsequent medical or pharmacy claim for mepolizumab within 6 months following the index date
    • ≥12 months of continuous eligibility prior to the index date (defined as the baseline period)
    • ≥12 months of continuous eligibility after the index date (defined as the follow-up period)
    • ≥1 diagnosis of EGPA during the baseline period or on the index date
    Exclusion criteria:
    • ≥1 medical or pharmacy claim for mepolizumab any time before the index date
    • ≥1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, or dupilumab during the baseline period or on the index date

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2023-09-05
    Actual study completion date
    2023-09-05

    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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