Evaluation of MEpolizumab-based regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis

Prior treatment

• Patients with contraindication to use mepolizumab, cyclophosphamide, mesna, azathioprine or maintenance therapy used for vasculitis
• Patients included in other investigational therapeutic study within the previous 3 months
• Patients unable to give written informed consent prior to participation in the study
• Patients with EGPA who have already been treated with mepolizumab or benraluzimab within the previous 6 months

Other illness

• Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol
• Patients with vasculitis in remission of the disease defined as a BVAS <3
• Patients with severe cardiac failure defined as class IV in New York Heart Association
• Patients with acute infections or chronic active infections (including HIV, HBV or HCV and checked in the last 12 months)
• Patients with hypersensitivity to a monoclonal antibody or biologic agent

Lab values

• Patients who have white blood cell count ≤4,000/mm3
• Patients who have platelet count ≤100,000/mm3
• Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease
• Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study and for WOCPB with FFS≥1 at least 12 months after stopping cyclophosphamide: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised Partner

Age

• Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment

Other

• Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference
• Patients suspected not to be observant to the proposed treatments
• Patients under tutorship or curatorship and protected adults
• Men with FFS≥1 who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 6 months after stopping cyclophosphamide (unless permanently sterile by bilateral orchidectomy)

• Patients with a diagnosis of EGPA independently of ANCA status
• Patient aged of 18 years or older
• Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥3
• Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy are authorized)
• Written informed consent prior to participation in the study
• Affiliation to social security or CMU (beneficiary or assignee)