Comparative Effectiveness Study of Mepolizumab Versus Omalizumab
Trial overview
Number of Asthma-related Hospitalizations Per Participant Year (PPY)
Timeframe: Up to approximately 77 months after treatment initiation
Number of Asthma-related Hospitalizations PPY Up to 12 Months After Treatment Initiation
Timeframe: Up to 12 months after treatment initiation
Number of Asthma-related Hospitalizations PPY Up to 24 Months After Treatment Initiation
Timeframe: Up to 24 months after treatment initiation
Number of Asthma Exacerbations PPY
Timeframe: Up to approximately 77 months after treatment initiation
Number of Asthma-related Hospitalizations PPY Following Persistent Use of Mepolizumab or Omalizumab for at Least 6 Months After Initiation
Timeframe: Up to approximately 77 months after treatment initiation
Number of Asthma Exacerbations PPY Following Persistent Use of Mepolizumab or Omalizumab for at Least 6 Months After Initiation
Timeframe: Up to approximately 77 months after treatment initiation
- Great than or equal to (>=) 2 consecutive medical or pharmacy claims for the same biologic agent (either mepolizumab or omalizumab) on or after January 1, 2019
- The first observed claim will be defined as the index date and the second claim must occur within 6 months of the index date
- >=1 diagnosis for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency during the baseline period or on the index date
- >=1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab any time prior to the index date
- >=12 months of Medicare FFS continuous clinical activity prior to the index date (baseline period)
- >=2 diagnoses of asthma on separate visits in any position during the baseline period or on the index date
- >=1 asthma exacerbation during the baseline period or on the index date
- >=18 years of age at the index date
- (Persistent use subgroup only) Persistent to the index biologic agent for at least 6 months following biologic initiation
- Persistence will be defined as no treatment gap exceeding the equivalent of two consecutive doses and a receipt of more than 50 percent (%) of the expected doses based on labelled dosing frequency
Great than or equal to (>=) 2 consecutive medical or pharmacy claims for the same biologic agent (either mepolizumab or omalizumab) on or after January 1, 2019
The first observed claim will be defined as the index date and the second claim must occur within 6 months of the index date
Continuous clinical activity will be defined as consecutive quarters with >=1 medical and >=1 pharmacy claim
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, all participants aged >=18 years will be included.
- >=1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab any time prior to the index date
- >=1 diagnosis for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), or pulmonary eosinophilia during the baseline period or on the index date
- Participants with EGPA, HES, CSU, and CRSwNP will be excluded as these represent non-asthma indications that may drive biologic initiation independent of asthma severity. In addition, participants with pulmonary eosinophilia will be excluded, as this condition reflects eosinophilic lung disease that may influence selection of anti-interleukin (IL)-5 or IL-5 receptor therapies independent of asthma-related factors. This approach aims to minimize confounding by treatment indication while preserving generalizability to the broader severe asthma population
>=1 diagnosis for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency during the baseline period or on the index date
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.