This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.
Patients age 18 to 65 years, both genders can be included.
Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).
Patients have to be ANCA-positive at diagnosis or during the course of their disease.
Patients with TPMT gene mutation.
Patients who had been treated with either AZA but relapsed in the past.
Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.
Patients who have planned for pregnancy in next 1.5 years.
Parallel
Azathioprine
DrugAll patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
Telitacicept
DrugPatient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months
The time of first relapse during 12 months follow-up of two groups
The time from baseline to first relapse(re-appearance of disease with a BVAS \>0) of patients during 12 months follow-up of two groups
The percentage of patients with severe relapse at months 12
The percentage of patients with severe relapse (re-appearance or worsening of disease with a BVAS ≥6 and involvement of at least one major organ, a life-threatening manifestation, or both) at months 12
The percentage of patients with moderate relapse at months 12
The percentage of patients with moderate relapse (re-appearance or worsening of disease with a BVAS ≥3 without involvement of major organ or life-threatening manifestation) at months 12
The percentage of patients with mild relapse at months 12
The percentage of patients with mild relapse (re-appearance or worsening of disease with a 0 \< BVAS \< 3 without involvement of major organ or life-threatening manifestation) at months 12
The percentage of patients with sustained remission at months 12
The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12
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