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Real-World Changes in Glucocorticoid Use in Japanese Patients with Eosinophilic Granulomatosis with Polyangiitis Treated with Benralizumab:A Retrospective Multicenter Study

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Eosinophilic Granulomatosis with Polyangiitis
Date of first enrollment	01/07/2026
Target sample size	100
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

To describe the proportion of patients with EGPA who are not receiving systemic GC during Week 50-54 after benralizumab initiation.

Secondary Outcome

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, >5.0 to <=7.5, >7.5 to <=20, and >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.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.