This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in children with Acute Kawasaki Disease (KD) .
Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
Not treated with IVIG yet
Age >28 days，<18 years
Receiving steroids or other immunosuppressive agents in the previous 30 days;
With a previous history of KD;
Afebrile before enrolment;
Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;
Parallel
IVIG
DrugIVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
Aspirin
DrugAspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Firsekibart
DrugFirsekibart 3 mg/kg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.
Occurrence of coronary artery lesions (CAL) at one month of illness
Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.
Occurrence of the need for rescue therapy
Temperature will be measured every 6 hours a day during hospitalization. Participants who have recurrent or persistent fever (temperature ≥38°C) after 36 hours of completion of initial IVIG infusion will be given rescue therapy.
Duration of fever (hours) after initiation of initial IVIG infusion
Temperature will be measured every 6 hours a day during hospitalization. Participants with temperature \<37.5℃ for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal.
Change in serum C-reactive protein (CRP) concentration
Serum CRP levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
Change in Serum Amyloid A (SAA) concentration
SAA levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
Change in serum interleukin (IL)-1β concentration
Serum IL-1β levels will be measured at two time points: at enrolment, 72 hours after completion of the initial IVIG infusion.
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Children's Hospital of Fudan University
Lead sponsor
Jiangxi Province Children's Hospital
Collaborator
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