Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete Response
研究概览
简要总结
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.
详细描述
BELONG-EGPA is a multicenter, retro-prospective observational study conducted within centers belonging to the European EGPA Study Group. The study is designed to evaluate the long-term real-world effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The study population will include adult patients with EGPA who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for EGPA or the criteria proposed in the MIRRA trial, and who receive benralizumab 30 mg every 4 weeks. Only patients with at least 3 months of available follow-up after starting benralizumab will be included.
Demographic, clinical, biological, lung function, and treatment-related data will be collected from medical charts through a standardized electronic case report form. Data will be collected at the start of benralizumab treatment and at 3, 6, 12, and 24 months of follow-up.
The primary effectiveness outcomes include achievement of complete response and partial response, changes in lung function measured by pre-bronchodilator FEV1, and disease relapses. Complete response is defined as no disease activity, with Birmingham Vasculitis Activity Score equal to 0, and an oral corticosteroid dose of 4.0 mg/day or less of prednisone, prednisolone, or equivalent. Partial response is defined as no disease activity with an oral corticosteroid dose greater than 4.0 mg/day.
Secondary outcomes include treatment persistence, oral corticosteroid tapering and discontinuation, effectiveness and safety in first-line patients compared with patients previously exposed to mepolizumab, outcomes after benralizumab dosage switching, and adverse events and serious adverse events during treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Written informed consent for study participation and data collection.
排除标准
- •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.
研究组 & 干预措施
Patients with EGPA treated with benralizumab
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting. Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.
干预措施: Benralizumab 30 mg/ml (Biological)
结局指标
主要结局
Complete Response
时间窗: Baseline and up to 24 months (at 3, 6, 12, 24 months)
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.
Change in Lung Function
时间窗: Baseline, 3, 6, 12, and 24 months
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters
Disease relapse
时间窗: 3, 6, 12, and 24 months
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.
Partial response
时间窗: Baseline and up to 24 months (at 3, 6, 12, 24 months)
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.
次要结局
- Treatment persistence(3, 6, 12, and 24 months)
- Change in oral corticosteroid dose expressed as prednisone-equivalent dose(Baseline, 3, 6, 12, and 24 months)
- Oral corticosteroid discontinuation(3, 6, 12, and 24 months)
- Overall clinical benefit in first-line versus post-mepolizumab patients(Baseline, 3, 6, 12, and 24 months)
- Effectiveness after benralizumab dosage switching(3 months after dosage switch)
- Adverse event rate(3, 6, 12, and 24 months)