Last updated: 09/02/2022 09:10:10

Impact of Mepolizumab (NUCALA®) on a High Cost Population

GSK study ID
212693
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: Impact of Mepolizumab (Nucala) on a High Cost Population
Trial description: This study will be a retrospective analysis of participants with life threatening asthma who are new users of mepolizumab (NUCALA) in the MarketScan Commercial and Medicare Supplemental Databases. Participants with an administration of mepolizumab between 01 November 2015 and 31 December 2018 will be identified. This study will identify participants with asthma with the top 20% of cost and a high rate of Baseline comorbidities prior to receiving mepolizumab to investigate the annual rate of asthma exacerbations a year before exposure to mepolizumab compared with the year after. MarketScan is a registered trademark of Thomson Reuters (Healthcare) Inc. NUCALA is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annual rate of asthma exacerbations at Baseline and at follow-up

Timeframe: Baseline (within 12 months prior to first dose) and up to 12 months (follow-up)

Secondary outcomes:

Number of participants with Oral Corticosteroids (OCS) use at Baseline and at follow-up

Timeframe: Baseline (within 12 months prior to first dose) and up to 12 months (follow-up)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-26-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Njira L Lugogo, Michael Bogart, Thomas Corbridge, Elizabeth R Packnett, Joanne Wu, Beth Hahn. Impact of mepolizumab in patients with high-burden severe asthma within a managed care population. The Journal of asthma : official journal of the Association for the Care of Asthma. 2023-Apr;60(4): 811-823. DOI:10.1080/02770903.2022.2102036 PMID: 35853158
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2020 to February 2021
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Participants with mepolizumab administration between 01 November 2015 and 31 December 2018. The date of the first claim for mepolizumab during the participant identification period will be considered the index date.
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Participants with evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC] codes) during the 12-month Baseline or follow-up period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with mepolizumab administration between 01 November 2015 and 31 December 2018. The date of the first claim for mepolizumab during the participant identification period will be considered the index date.
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits after the index date (follow-up period).
  • Participants with at least 12 years of age on the index date.
  • Participants with greater than or equal to 1 asthma diagnosis in any position on a non-diagnostic medical claim during the 12-month Baseline period.
  • Participants with greater than or equal to 2 mepolizumab administrations during the first 6 months of the follow-up period.
  • Participants with one or more of the following: Total healthcare expenditures greater than or equal to 80th percentile during the 12-month Baseline period; Deyo Charlson Comorbidity Index (DCI) score greater than or equal to 3 during the 12-month Baseline period.
Exclusion criteria:
  • Participants with evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC] codes) during the 12-month Baseline or 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
2021-26-02
Actual study completion date
2021-26-02

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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