Benralizumab Effectiveness in EGPA (BELONG-EGPA)

European EGPA Study Group

Status: Enrolling

Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Treatments: Biological: Benralizumab 30 mg/ml

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07815886

BENRA_22336_oss

22336_oss (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Additional outcomes include changes in organ manifestations, discontinuation of disease-modifying antirheumatic drugs, changes in ANCA status, and variation in eosinophil count. All data will be anonymized and stored in a centralized database.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

100 participants in 1 patient group

Patients with EGPA treated with benralizumab

Description:

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.

Treatment:

Biological: Benralizumab 30 mg/ml