Efficacy and Safety of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
• Age: This study will include subjects aged 18 to 75 years (inclusive), regardless of gender.
• Subjects must be willing to participate in the study and voluntarily sign an informed consent form.
• Diagnosis of AOSD will be based on the Yamaguchi criteria: Major criteria: (1) Fever ≥39°C lasting for ≥1 week; (2) Arthralgia lasting for ≥2 weeks; (3) Typical rash; (4) White blood cell count ≥10×10\^9/L with neutrophils ≥80%. Minor criteria: (1) Sore throat or pharyngitis; (2) Lymphadenopathy and/or splenomegaly; (3) Abnormal liver function; (4) Negative rheumatoid factor and antinuclear antibody. Exclusion criteria: (1) Infectious diseases (especially sepsis and EBV infection); (2) Malignancies (especially lymphoma); (3) Other rheumatic diseases (particularly systemic vasculitis). After excluding the above exclusion criteria, a diagnosis of AOSD requires meeting ≥5 of the above criteria (including at least 2 major criteria).
• Active disease is defined as meeting 2 Yamaguchi criteria along with the presence of fever or CRP \>10 mg/L.
• If currently receiving glucocorticoid therapy, the dose must have been stable for at least 1 week prior to randomization. The maximum allowed dose is 1 mg/kg/day.
• Subjects (including their partners) must have no pregnancy plans from the screening period until 28 days after the last dose and must voluntarily use contraception.