New hope for EGPA: rituximab shows promise in major trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) , * Patient able to give written informed consent prior to participation in the study. Exclusion Criteria: * Patients with GPA, MPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, * 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 Assocation * Patients with acute infections or chronic active infections (including HIV, HBV or HCV), * Patients with active cancer or recent cancer (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, * Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the 12 months duration of the study, * Patients with EGPA who have already been treated with rituximab within the previous 12 months, * Patients with hypersensitivity to a monoclonal antibody or biologic agent, * Patients with contraindication to use rituximab, cyclophosphamide, mesna or azathioprine, * 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 included in other investigational therapeutic study within the previous 3 months, * Patients suspected not to be observant to the proposed treatments, * 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, * Patients unable to give written informed consent prior to participation in the study.