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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2023-27-03
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)

No location data available.

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
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website