IVIG Alone Is as Effective as IVIG Plus Aspirin in Kawasaki Disease: JAMA

Kawasaki disease is a self-limited inflammatory disease that mainly occurs in children less than 5 years old and is the major cause of acquired cardiovascular disease in children. Standard therapy has traditionally incorporated IVIG with high-dose aspirin in an effort to minimize the risk of coronary artery lesions. Researchers performed a prospective, multicenter, evaluator-blinded, noninferiority trial to compare the outcomes of IVIG alone with IVIG plus high-dose aspirin in children with KD.

The trial was performed in five large medical centers in Taiwan. 134 children less than 6 years of age, diagnosed by the American Heart Association criteria of KD, were recruited from September 2016 to August 2018. Participants were equally divided into two treatment arms: one received IVIG alone (2 g/kg), and the other received IVIG (2 g/kg) with high-dose aspirin (80–100 mg/kg per day) until fever had remitted for a period of at least 48 hours.

Follow-up assessment was conducted at 6 weeks and 6 months after treatment. The researchers assessed the progression of coronary artery lesions as the main outcome measure using the noninferiority margin of 10%. More sophisticated statistical analysis, such as the chi-square tests and repeated measures analysis, were employed for strong data interpretation.

Key Findings

• The last sample consisted of 134 patients, with a mean age of 1.8 years (SD 1.3 years), and 82 (61.2%) were male. The two treatment groups were comparable regarding age, weight, height, and sex distribution.

In the IVIG plus aspirin group (69 patients):

• CALs were present in 9 children (13.0%) at baseline.

• CALs decreased to 2 children (2.9%) at 6 weeks.

• CALs decreased further to 1 child (1.4%) at 6 months.

In IVIG-only cohort (65 children):

• CALs were noted in 7 children (10.8%) at diagnosis.

• CALs decreased to 1 child (1.5%) at 6 weeks.

• CALs increased marginally to 2 children (3.1%) at 6 months.

• There was no statistically significant difference in the incidence of coronary artery lesions between the two cohorts at any of the time points. The 6-week difference in occurrence of CAL in the groups was only 0.7 percentage points (95% CI, –4.5 to 5.8; p=0.65), safely within the noninferiority margin set a priori at 10%.

• Furthermore, no clinically relevant differences in prophylactic or treatment effects were seen, supporting the conclusion that high-dose aspirin was not providing added clinical benefit here.

The study authors concluded that IVIG monotherapy is similar in effect to IVIG plus high-dose aspirin for prevention of coronary artery lesions in pediatric Kawasaki disease. The research emphasizes that the addition of high-dose aspirin is not associated with clinically significant benefit within initial therapy.

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