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Infliximab failed to reduce treatment resistance of Kawasaki disease
The addition of infliximab to standard therapy for Kawasaki disease does not appear to decrease treatment resistance, but it may reduce fever duration, some inflammatory markers, anterior descending coronary artery z score and IV immunoglobulin reaction rates, according to recent findings.
In the phase 3, randomized, double blind, placebo-controlled trial, the researchers enrolled 196 patients at Rady Children’s Hospital in San Diego. The patients were aged 4 weeks to 17 years, were diagnosed with Kawasaki disease and had a fever (≥38°C) for 3 to 10 days.
The children in the study were randomly assigned to IV infliximab (Remicade, Janssen Biotech) 5 mg/kg at 1 mg/mL for 2 hours (n=98) or IV saline 5 mL/kg (n=98).
All patients received standard treatment with diphenhydramine (1 mg/kg IV, maximum 50 mg) and acetaminophen (15 mg/kg orally, maximum 650 mg) 30 minutes before receiving the study drug. Difference in treatment resistance between the groups was the study’s primary outcome.
The researchers found there was no significant difference in treatment resistance between the groups (11.2% for infliximab vs. 11.3% for placebo; P=.81). Patients who received infliximab treatment had fewer days of fever than those in the placebo group (median 1 day for infliximab vs. 2 days for placebo; P<.0001). Infliximab treatment also yielded greater mean reductions in the rate of erythrocyte sedimentation at 2 weeks vs. placebo (P=.009).
Infliximab resulted in a twofold greater reduction in z score of the left anterior descending artery (P=.045) vs. placebo at 2 weeks, but the difference was not significant at week 5. Similarly, at 24 hours after treatment, the patients in the infliximab group had a greater mean decrease in C-reactive protein concentration (P=.0003) and in absolute neutrophil count (P=.024) vs. those who received placebo; this difference was no longer significant by week 2. At week 5, there was no significant difference vs. baseline in any laboratory findings.
Additionally, no significant differences were seen at any time between the groups in proximal right coronary artery z scores, age-adjusted hemoglobin values, length of time in the hospital, or any other inflammatory markers measures. The researchers observed no reactions to IV immunoglobulin infusion in patients who received infliximab vs. 13.4% in placebo patients (P<.0001); no serious adverse events were reported in relation to infliximab treatment.
“The addition of infliximab to initial therapy did not affect treatment resistance,” the researchers wrote. “However, administration of infliximab shortened the duration of fever, eliminated the risk of infusion reactions if given before [IV immunoglobulin], and more rapidly reduced inflammation.”
Disclosure: The researchers report no relevant financial disclosures.