What the trial was testing
The KIDCARE enrolled 105 patients with kawasaki disease. The study was sponsored by University of California, San Diego and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
77% had fever resolution on infliximab vs. 51% on repeat IVIG.
The Lancet Child & Adolescent Health · 2021 · NCT03065244
These findings — that fever resolution at 24 hours on infliximab vs. repeat IVIG for resistant Kawasaki — were published in the The Lancet Child & Adolescent Health and represent the headline result of the study.
Researchers tracked outcomes across 105 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with kawasaki disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Infliximab is FDA-approved for several inflammatory diseases (not specifically Kawasaki disease) and is widely used off-label for IVIG-resistant Kawasaki. The American Heart Association supports it as an option for resistant cases. Ask a pediatric rheumatologist or cardiologist about treatment.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open kawasaki disease trials
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis