Eosinophilic Granulomatosis with Polyangiitis
Conditions
Interventions
None listed
Sponsors
Maruyama Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years of age or older at the time of benralizumab initiation. 2. Patients diagnosed with EGPA before the time of benralizumab initiation according to either the ACR/EULAR classification criteria or the diagnostic criteria issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan. 3. Patients who received a new treatment for benralizumab for EGPA between January 2025 and December 2025, in accordance with the package insert indication stating that benralizumab is given to patients with EGPA for which existing therapies are inadequate. 4. Patients who were receiving systemic GC, with or without immunosuppressants at the time of benralizumab initiation. 5. Patients who provided written informed consent between July 2026 and January 2027.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with autoimmune disorders other than EGPA that require treatment with GC during baseline period. 2. Patients diagnosed with granulomatosis with polyangiitis (GPA; previously known as Wegener's granulomatosis) or microscopic polyangiitis (MPA). 3. Patients treated with rituximab in the 6 months prior to initiation of benralizumab. 4. Patients treated with omalizumab, dupilumab or tezepelumab for severe asthma within 6 months before initiation of benralizumab for EGPA. 5. Patients treated with benralizumab in combination with another biologics (tezepelumab, omalizumab, dupilumab, or mepolizumab). 6. Patients participating in clinical trials during baseline period and follow up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the proportion of patients with EGPA who are not receiving systemic GC during Week 50-54 after benralizumab initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe the proportion of patients with EGPA who were not receiving systemic GC or receiving systemic glucocorticoids solely for adrenal insufficiency during Weeks 50-54 after benralizumab initiation. 2. To describe the proportion of patients who achieved GC-free or low-dose GC remission at Week 52 after benralizumab initiation. Remission will be defined according to two patterns: GC-free remission: Absence of disease activity and systemic GC dose of 0 mg/day at Week 52. Low-dose GC remission: Absence of disease activity and systemic GC dose of 0-4 mg/day at Week 52. Absence of disease activity will be defined as no worsening of existing symptoms and no emergence of new symptoms, as assessed by the attending physician over the past 4 weeks. 3. To describe the mean daily systemic GC dose by month after benralizumab initiation. 4. To summarize the mean daily systemic GC dose by category by month after benralizumab initiation. Categories: daily GC dose (0, >0 to 5.0 to 7.5 to 20 mg/day). 5. To describe the proportion of patients without relapses during the follow-up period after benralizumab initiation. Relapse: Defined as the worsening of existing symptoms or the emergence of new symptoms assessed by the attending physician, together with one or more of the following: increase in systemic GC therapy (total daily prednisolone dose >=4 mg/day, or equivalent), increase or addition of immunosuppressants, or hospitalization due to exacerbation of EGPA. | — |
Contacts
Public ContactHitomi Uchimura
AstraZeneca K.K.
Outcome results
None listed