Last updated: 12/19/2025 06:50:16
Long-term Impact of mepolizumab on systemic corticosteroid-Related Complications
GSK study ID
308679
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: Long-Term Effectiveness of Mepolizumab Versus Other Biologics on Asthma Outcomes among Patients with Medicare Fee-for-Service Insurance in the United States
Trial description: This study will provide essential evidence on the relative long-term effectiveness of mepolizumab and other biologics in routine clinical practice among Medicare Fee-for-Service (FFS) beneficiaries with asthma. The goal of the study is to evaluate and compare the long-term effectiveness of mepolizumab versus other biologic agents (i.e., dupilumab, benralizumab, and omalizumab) on asthma outcomes (i.e., asthma-related hospitalizations and asthma exacerbations) among participants with asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of asthma-related hospitalizations
Timeframe: Up to 3 years
Secondary outcomes:
Rates of asthma exacerbations (i.e., overall, Inpatient (IP)/ Emergency department (ED)-defined, and Systemic corticosteroid (SCS)-defined)
Timeframe: Up to 3 years
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-20-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2025 to March 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=)2 consecutive medical or pharmacy claims for the same biologic agent (mepolizumab, dupilumab, benralizumab, or omalizumab) on or after 01 January 2019
- Greater than or equal to (>=)12 months of Medicare FFS continuous clinical activity prior to the index date (Baseline period) and after the index date (landmark period)
- Greater than or equal to (>=)1 diagnosis for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency during the Baseline period or on the index date
- Greater than or equal to (>=)1 medical or pharmacy claim for any biologic agents (i.e., mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab) prior to the index date
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to (>=)2 consecutive medical or pharmacy claims for the same biologic agent (mepolizumab, dupilumab, benralizumab, or omalizumab) on or after 01 January 2019
- Greater than or equal to (>=)12 months of Medicare FFS continuous clinical activity prior to the index date (Baseline period) and after the index date (landmark period) o Continuous clinical activity will be defined as consecutive quarters with >=1 medical and >=1 pharmacy claim, and will serve as a proxy for continuous insurance coverage, which is not directly available in the Komodo open claims data
- Persistent to the index biologic agent during the landmark period o Persistence will be defined as no treatment gap exceeding the equivalent of two consecutive doses AND receipt of more than 50 percentage (%) of the expected doses based on labelled dosing frequency.
- Greater than or equal to (>=)2 diagnoses of asthma in any position during the Baseline period or on the index date
- Greater than or equal to (>=)18 years of age at the index date o While most Medicare FFS beneficiaries are aged >=65 years, some younger adults qualify for Medicare due to disability or specific medical conditions. Because asthma affects adults across a wide age range, including all participants aged >=18 years ensures comprehensive representation of the Medicare FFS population.
- (Chronic obstructive pulmonary disease [COPD] subgroup only) >=1 diagnosis of COPD in any position during the Baseline period or on the index date
Exclusion criteria:
- Greater than or equal to (>=)1 diagnosis for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency during the Baseline period or on the index date
- Greater than or equal to (>=)1 medical or pharmacy claim for any biologic agents (i.e., mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab) prior to the index date
- Switch to another biologic during the 12-month landmark period (i.e., received >=1 medical or pharmacy claim for any biologic other than their index biologic)
- Greater than or equal to (>=)1 diagnosis for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EOE), pulmonary eosinophilia, or atopic dermatitis during the Baseline period o These conditions are additional indications for one or more of the biologic therapies of interest. Excluding participants with these diagnoses ensures that biologic initiation reflects treatment for asthma rather than other T2 inflammatory or eosinophilic diseases, thereby improving comparability across cohorts
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
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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