Last updated: 05/10/2024 20:00:15
Real world effectiveness of Nucala in patients who switched from other biologics to Nucala
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Real-World Impact of Switching to Mepolizumab from Other Biologics among Patients with Severe Asthma in the United States
Trial description: This study will assess the use of mepolizumab in treating severe eosinophilic asthma and evaluate asthma medication use, asthma exacerbations, and healthcare resource utilization (HRU) among participants who switched to mepolizumab from other biologics (i.e., omalizumab, reslizumab, benralizumab, dupilumab) in the United States (US). This retrospective cohort study will use US administrative claims from the Komodo Health’s comprehensive dataset. The index date is defined as the first dispensing/administration (i.e., date of switch) of mepolizumab between October 1, 2016, and March 1, 2019. Further, the baseline period is 12 months prior to the date of switch to mepolizumab and the observation/follow-up period of 12 months post study drug administration data will be collected for analysis.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of oral corticosteroid (OCS) dispensing per participant per year
Timeframe: Baseline (12 months pre-index date)
Mean number of OCS dispensing per participant per year after mepolizumab administration
Timeframe: 12 months post-index date
Total number of asthma exacerbations per participant-years during baseline period
Timeframe: Baseline (12 months pre-index date)
Total number of asthma exacerbations per participant-years during follow-up period
Timeframe: 12 months post-index date
Total number of asthma exacerbations with an oral or parenteral corticosteroid per participant-years during baseline period
Timeframe: Baseline (12 months pre-index date)
Total number of asthma exacerbations with an oral or parenteral corticosteroid per participant-years during follow-up period
Timeframe: 12 months post-index date
Secondary outcomes:
Number of participants receiving greater than or equal to (≥)1 OCS dispensing
Timeframe: 12 months pre-index date to 12 months post-index date
Mean number of OCS bursts
Timeframe: 12 months pre-index date to 12 months post-index date
Number of participants with average daily dose per dispensing
Timeframe: 12 months pre-index date to 12 months post-index date
Percentage of participants using ≥1 short-acting beta 2 agonist (SABA) canister
Timeframe: 12 months pre-index date to 12 months post-index date
Mean number of SABA canisters used per participant
Timeframe: 12 months pre-index date to 12 months post-index date
Number of participants with all-cause HRU
Timeframe: 12 months pre-index date to 12 months post-index date
Number of participants with asthma related HRU
Timeframe: 12 months pre-index date to 12 months post-index date
Number of participants with asthma exacerbation related HRU
Timeframe: 12 months pre-index date to 12 months post-index date
Number of participants with all types of HRU
Timeframe: 12 months pre-index date to 12 months post-index date
Interventions:
Enrollment:
0
Primary completion date:
2023-20-04
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2022 to April 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Participants with
- Greater than or equal to (≥) 1 medical or pharmacy claim for mepolizumab between October 1, 2016, and March 1, 2019. The earliest claim defines the index date
- Participants with
- ≥1 diagnosis (primary or secondary, i.e., any position) of any of the following conditions at any time during the study period:
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with
- Greater than or equal to (≥) 1 medical or pharmacy claim for mepolizumab between October 1, 2016, and March 1, 2019. The earliest claim defines the index date
- Age ≥12 years at the index date
- ≥12 months of continuous eligibility prior and after to the index date
- ≥ 1 diagnosis of asthma at any time during the baseline period or on index date
- ≥ 2 medical or pharmacy claims for mepolizumab in the first 6 months after the index date (including the index date)
- ≥ 1 dispensing or administration of omalizumab, reslizumab, benralizumab, or dupilumab during the baseline period
Exclusion criteria:
- Participants with
- ≥1 diagnosis (primary or secondary, i.e., any position) of any of the following conditions at any time during the study period: 1) Active tuberculosis 2) Cystic fibrosis
- ≥1 medical or pharmacy claim for mepolizumab at any time before the index date
- ≥1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, or dupilumab during the follow-up period
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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