Last updated: 03/26/2025 12:50:15

Long-term effectiveness of NUCALA (mepolizumab)

GSK study ID
217456
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: Long-Term Effectiveness of NUCALA in Patients with Asthma
Trial description: The objective is to characterize the long-term effectiveness of mepolizumab in real-world population with asthma using data from the MarketScan Commercial and Medicare Databases. 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 24 months following initiation of treatment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with asthma exacerbation

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with any oral corticosteroids (OCS) Use

Timeframe: 12 months pre-dose to 48 months post-dose

Number of OCS pharmacy claims

Timeframe: 12 months pre-dose to 48 months post-dose

Mean OCS daily dose

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with mean reduction in OCS daily dose

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with chronic OCS use

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with OCS burst

Timeframe: 12 months pre-dose to 48 months post-dose

Secondary outcomes:

Demographic characteristics of participants with asthma

Timeframe: 12 months pre-dose to 48 months post-dose

Clinical characteristics of participants with asthma

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with all-cause and exacerbation-related healthcare resource use

Timeframe: 12 months pre-dose to 48 months post-dose

Amount of money used with all-cause and exacerbation-related healthcare resource use

Timeframe: 12 months pre-dose to 48 months post-dose

Number of mepolizumab claims

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with at least 10 claims annually

Timeframe: 12 months pre-dose to 48 months post-dose

Time between each administration of mepolizumab

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants with adherence to mepolizumab treatment

Timeframe: 12 months pre-dose to 48 months post-dose

Number of participants persistent with mepolizumab treatment

Timeframe: 12 months pre-dose to 48 months post-dose

Duration of persistent with mepolizumab treatment measured in days

Timeframe: 12 months pre-dose to 48 months post-dose

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2023-27-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Moore W, Stach-Klysh A, Corbridge T, Packnett E, McMorrow D, Richards M, et al. . Real-world mepolizumab treatment in patients with severe asthma decreased exacerbations, oral corticosteroid use, and healthcare resource utilization and costs over 4 years: a retrospective analysis. J Asthma. PMID: 39786337 DOI: 10.1080/02770903.2025.2450640
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    October 2022 to March 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • At least one medical or pharmacy claim for mepolizumab between November 1, 2015, and September 30, 2019; the date of first biologic claim will be the index date
    • At least 12 months of continuous enrollment with medical and pharmacy benefits prior to the index date (baseline period)
    • No evidence of medical or pharmacy claims for mepolizumab, prior to the index date
    • No evidence of medical or pharmacy claims for benralizumab, omalizumab, reslizumab, or dupilumab during the follow-up period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one medical or pharmacy claim for mepolizumab between November 1, 2015, and September 30, 2019; the date of first biologic claim will be the index date
    • At least 12 months of continuous enrollment with medical and pharmacy benefits prior to the index date (baseline period)
    • At least 24 months of continuous enrollment with medical and pharmacy benefits after the index date (follow-up period)
    • At least 12 years of age on the index date
    • At least one non-diagnostic inpatient or outpatient claim with a diagnosis of asthma in the baseline period
    • At least two medical or pharmacy claims for mepolizumab during the first six months of the follow-up period
    Exclusion criteria:
    • No evidence of medical or pharmacy claims for mepolizumab, prior to the index date
    • No evidence of medical or pharmacy claims for benralizumab, omalizumab, reslizumab, or dupilumab during the follow-up period

    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
    2023-27-03
    Actual study completion date
    2023-27-03

    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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