Abstract
Purpose: To evaluate the diagnostic and predictive value of a 12-cytokine panel for Kawasaki disease (KD) and intravenous immunoglobulin (IVIG) resistance. Patients and methods: A retrospective case-control study was conducted using clinical data from children diagnosed with KD at Children's Hospital, Zhejiang University School of Medicine, between December 1, 2023, and March 30, 2025. Demographic characteristics, laboratory findings, and echocardiographic results were collected. KD patients were compared with febrile controls without KD. Differences in sex, age, 12-cytokine profile, complete blood count, C-reactive protein level, and erythrocyte sedimentation rate were analyzed. Additionally, cytokine levels were compared between IVIG-resistant and IVIG-responsive KD patients to assess their predictive value for IVIG resistance. Results: A total of 686 KD patients and 101 febrile non-KD controls were enrolled. Compared with controls, KD patients were significantly younger and presented higher levels of IFN-α, IL-10, IL-1β, IL-2, IL-4, IL-5, IL-6, and IL-8, as well as elevated neutrophil counts and white blood cell counts. Logistic regression analysis identified age (in months), IL-10, IL-5, and the absolute neutrophil count as independent predictors of KD diagnosis. Among the KD patients, 80 were IVIG resistant. Compared with IVIG-responsive patients, IVIG-resistant patients presented significantly higher levels of IFN-γ, IL-10, IL-17, IL-2, IL-5, IL-6, and IL-8 but lower levels of IFN-α. Logistic regression revealed that IL-10 and IL-8 were independent predictors of IVIG resistance. When the concentration of IL-10 exceeded 14.70 pg/mL, the sensitivity and specificity for predicting IVIG resistance were 0.675 and 0.748, respectively. Similarly, when the concentration of IL-8 exceeded 23.55 pg/mL, the sensitivity and specificity were 0.725 and 0.658, respectively. Conclusion: The 12-cytokine panel has potential as a diagnostic and predictive tool for KD. Elevated IL-10 and IL-5 levels are independent predictors of KD diagnosis, whereas elevated IL-10 and IL-8 levels are independent predictors of IVIG resistance. These findings support the clinical utility of cytokine profiling in KD management.