Last updated: 02/13/2025 16:50:07
Real-world Effectiveness of Nucala in Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES) in the United States (US)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Effectiveness of Nucala in Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES)
Trial description: This is a retrospective analysis using pre-post study design of datasets derived from Mayo Clinic’s Electronic health record (EHR). This study aims to evaluate and compare oral corticosteroid (OCS) and other immunosuppressant medication use, symptom status, and healthcare resource utilization (HRU), as well as describe clinical outcomes and various organ system manifestations of participants treated with mepolizumab among two distinct cohorts of participants diagnosed with either EGPA or HES.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Average daily dose per all-cause oral corticosteroid (OCS) prescription among EGPA and HES participants
Timeframe: 12 months pre-dose and 12 months post-dose
Secondary outcomes:
Baseline demographic and clinical characteristics of EGPA and HES participants
Timeframe: 12 months pre-dose
Average daily all-cause oral corticosteroid and systemic steroid (OCS/SCS) dose among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Average daily all-cause oral corticosteroid and systemic steroid (OCS/SCS) dose among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Number and percentage of participants with greater than or equal to (≥)1 OCS/SCS order/administration among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Number and percentage of participants with greater than or equal to (≥)1 OCS/SCS order/administration among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Cumulative and average daily dose of OCS/SCS among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Cumulative and average daily dose of OCS/SCS among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Rate of OCS/SCS orders/administrations and bursts among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Rate of OCS/SCS orders/administrations and bursts among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Number of participants with continuous, continuous low, continuous medium, continuous high, and chronic use of OCS/SCS among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Number and percentage of participants with continuous, continuous low, continuous medium, continuous high, and chronic use of OCS/SCS among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Number and percentage of participants with ≥1 other immunosuppressant medication among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Number and percentage of participants with ≥1 other immunosuppressant medication among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Rate of other immunosuppressant medication usage among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Rate of other immunosuppressant medication usage among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Average dose of other immunosuppressant medication usage among EGPA and HES participants
Timeframe: 6,12 months pre-dose and 6,12 months post-dose
Average dose of other immunosuppressant medication usage among EGPA and HES participants
Timeframe: 12 months pre-dose and variable-length period (minimum 12-months post dose)
Interventions:
Enrollment:
347
Primary completion date:
2024-31-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Eosinophilic Granulomatosis with Polyangiitis
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
August 2023 to January 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- EGPA cohort –
- Greater than or equal to (≥)6 months of clinical activity prior to the index date, defined as a participant having at least one clinical encounter at Mayo relating to EGPA care within the time window.
- EGPA participants who are less than 18 years of age at the time of mepolizumab administration will be excluded.
- HES participants who are less than 12 years of age at the time of mepolizumab administration will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- EGPA cohort –
- Greater than or equal to (≥)6 months of clinical activity prior to the index date, defined as a participant having at least one clinical encounter at Mayo relating to EGPA care within the time window.
- ≥6 months of clinical activity after the index date, defined as a participant having at least one clinical encounter at Mayo relating to EGPA care within the time window
- For final inclusion criteria, participants are required to meet both the following conditions: (a) Eligible EGPA participants will be identified using either ICD diagnosis code and/or Unstructured clinical note (b) EGPA diagnosis confirmed based on at least two additional features of EGPA noted from the unstructured clinical text of physician notes: o biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration or eosinophil-rich granulomatous inflammation o neuropathy, mono or poly (motor deficit or nerve conduction abnormality) o pulmonary infiltrates, non-fixed o Sino-nasal abnormality o cardiomyopathy (established by echocardiography or Magnetic resonance imaging [MRI]) o glomerulonephritis (haematuria, red cell casts, proteinuria) o alveolar haemorrhage (by bronchoalveolar lavage) o palpable purpura o ANCA positive (MPO or PR3) HES cohort –
- ≥6 months of clinical activity prior to the index date, defined as a participant having at least one clinical encounter at Mayo relating to HES care within the time window.
- ≥6 months of clinical activity after the index date, defined as a participant having at least one clinical encounter at Mayo relating to HES care within the time window
- For final inclusion criteria, participants are required to meet both the following conditions: (a) Eligible HES participants will be identified using either ICD diagnosis code and/or Unstructured clinical note (b) HES diagnosis confirmed based on additional features of HES noted from the unstructured clinical text of physician notes: o Blood eosinophilia ≥1,500/millimeter cube (mm^3) without a discernable secondary cause (e.g., allergic diseases, drug hypersensitivity, parasitic helminth infections, human immune virus (HIV) infection, nonhematologic malignancies)
Exclusion criteria:
- EGPA participants who are less than 18 years of age at the time of mepolizumab administration will be excluded.
- HES participants who are less than 12 years of age at the time of mepolizumab administration will be excluded.
- EGPA participants who received mepolizumab prior to December 12, 2017, or after January 1, 2022. HES participants who received mepolizumab prior to September 25, 2020, or after January 1, 2022.
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
Study complete
Actual primary completion date
2024-31-01
Actual study completion date
2024-31-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website