Last updated: 12/09/2022 11:40:08
Mepolizumab Medicare Study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Changes in Asthma Exacerbation, Oral Corticosteroids Use, and Asthma Exacerbation-Related Costs Following Initiation of Mepolizumab Therapy: A Medicare Analysis of Patients with Asthma
Trial description: Asthma is a common chronic respiratory disorder that effects millions of children and adults in the United States (US). Recent real-world database studies have been conducted in participants with asthma treated with mepolizumab to investigate the impact of mepolizumab on oral corticosteroids (OCS) use, exacerbation and healthcare resource utilization (HCRU) related costs, using a commercial insurance database. Studies have not been conducted using Centers for Medicare and Medicaid Services (CMS) Medicare fee-for-services datasets to describe the real-world impact of mepolizumab on OCS, exacerbation and exacerbation-related costs in this important population. This is a retrospective cohort study, which will examine the change in asthma exacerbation, oral corticosteroids (OCS) use, and asthma exacerbation-related costs following initiation of mepolizumab therapy among participants diagnosed with asthma using the Centers for Medicare and Medicaid Services (CMS) fee-for-service Medicare data from 01-Jan -2016 through 31-Dec-2018.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with asthma exacerbations at Baseline
Timeframe: At Baseline (12 months before initiation of mepolizumab)
Number of participants with asthma exacerbations at follow up
Timeframe: Up to 12 months post-dose of mepolizumab
Secondary outcomes:
Number of participants with any OCS use
Timeframe: At Baseline (12 months before initiation of mepolizumab) and Follow-up (up to 12 months post-dose of mepolizumab)
Number of participants with OCS pharmacy claims
Timeframe: At Baseline (12 months before initiation of mepolizumab) and Follow-up (up to 12 months post-dose of mepolizumab)
Number of participants with chronic OCS use
Timeframe: At Baseline (12 months before initiation of mepolizumab) and Follow-up (up to 12 months post-dose of mepolizumab)
Number of participants with at least one OCS burst
Timeframe: Up to 28 days
Interventions:
Not applicable
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2021-13-04
Time perspective:
Retrospective
Clinical publications:
Sethi S, Bogart M, Corbridge T, Cyhaniuk A, Hahn B. Impact of Mepolizumab on Exacerbations in the US Medicare Population. J Allergy Clin Immunol Pract. 2022;
DOI: https://doi.org/10.1016/j.jaip.2022.10.021
PMID: NULL
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
May 2020 to April 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 65 Years
Accepts healthy volunteers
No
- Participants who had >=1 prescription/administration claim for mepolizumab during the identification period (01-Jan-2017 to 31-Dec-2017); the first prescription/administration claim for mepolizumab during this period will be designated as the index date
- Participants included who aged >=12 years on the index date.
- Participants who had >=1 prescription/administration of mepolizumab use during the 12-month Baseline period.
- Participants who had >=1 prescription claims for omalizumab, reslizumab, benralizumab, or dupilumab during the 12-month Baseline or follow-up period, to exclude the use of other biologics maintenance therapy for asthma.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who had >=1 prescription/administration claim for mepolizumab during the identification period (01-Jan-2017 to 31-Dec-2017); the first prescription/administration claim for mepolizumab during this period will be designated as the index date
- Participants included who aged >=12 years on the index date.
- Participants who had continuous health plan enrollment with medical and pharmacy benefits for the 12 months before the index date (Baseline period).
- Participants who had continuous health plan enrollment with medical and pharmacy benefits for the 12 months after the index date (follow-up period)
- Participants who had >=1 diagnosis claim for asthma during the 12-month Baseline period.
- Participants who had >=2 prescription/administration claims for mepolizumab during the first 6 months of the follow-up period.
Exclusion criteria:
- Participants who had >=1 prescription/administration of mepolizumab use during the 12-month Baseline period.
- Participants who had >=1 prescription claims for omalizumab, reslizumab, benralizumab, or dupilumab during the 12-month Baseline or follow-up period, to exclude the use of other biologics maintenance therapy for asthma.
Trial location(s)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
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
2021-13-04
Actual study completion date
2021-13-04
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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