Benralizumab Effectiveness in EGPA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean EGPA Study Group
About this trial
This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) according to the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria or the criteria proposed in the MIRRA trial.
Treatment with benralizumab 30 mg every 4 weeks.
At least 3 months of available follow-up data after starting benralizumab.
Disqualifiers
Age younger than 18 years.
No available follow-up data after starting benralizumab.
Follow-up after benralizumab initiation shorter than 3 months.
Lack of written informed consent, where required by local regulations.
Trial population
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Benralizumab 30 mg/ml
Biological/VaccineBenralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab. Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients with EGPA treated with benralizumab1 intervention
Trial outcomes
Primary outcomes
1
Complete Response
Proportion of patients achieving complete response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day.
Time frame
Baseline and up to 24 months (at 3, 6, 12, 24 months)2
Change in Lung Function
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters
Time frame
Baseline, 3, 6, 12, and 24 months3
Disease relapse
Proportion of patients experiencing disease relapse after achieving complete response. Relapse is defined as active vasculitis, BVAS \>0, and/or worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.
Time frame
3, 6, 12, and 24 months4
Partial response
Proportion of patients achieving complete response during follow-up. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day.
Time frame
Baseline and up to 24 months (at 3, 6, 12, 24 months)Secondary outcomes
1
Treatment persistence
Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.
Time frame
3, 6, 12, and 24 months2
Change in oral corticosteroid dose expressed as prednisone-equivalent dose
The daily dose of each oral corticosteroid will be converted to prednisone-equivalent mg/day using standardized glucocorticoid equivalence factors. Unit of Measure: mg/day of prednisone equivalent
Time frame
Baseline, 3, 6, 12, and 24 months3
Oral corticosteroid discontinuation
Proportion of patients who discontinue oral corticosteroid therapy during follow-up.
Time frame
3, 6, 12, and 24 months4
Overall clinical benefit in first-line versus post-mepolizumab patients
A comparison of the overall clinical benefit in patients treated with benralizumab as first-line therapy versus patients switching to benralizumab following prior exposure to mepolizumab. Unit of Measure: Percentage of participants
Time frame
Baseline, 3, 6, 12, and 24 monthsOther outcomes
1
Changes in organ manifestations
Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.
Time frame
Baseline, 3, 6, 12, and 24 months2
DMARD discontinuation rate
Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.
Time frame
3, 6, 12, and 24 months3
Change in ANCA positivity
Change in the proportion of patients with positive ANCA testing and proportion of patients with ANCA negativization among those who were ANCA-positive at baseline.
Time frame
Baseline, 3, 6, 12, and 24 months4
Change in eosinophil count
Change in blood eosinophil count from baseline to each follow-up time point.
Time frame
Baseline, 3, 6, 12, and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov