What does this research mean for the field?

A baseline model incorporating elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin predicts the occurrence of ICI-associated myocarditis, while specific electrocardiographic abnormalities and marked CK elevation at onset predict severe cases. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

March 31, 2026Open Access

Integrated risk stratification for ICI-associated myocarditis: a baseline hematological profile and a combined ECG and enzymatic signature at onset

Q: What is the clinical evidence from this study?

Study design: Case-Control. Population: ICI-associated myocarditis (n=196). Intervention: Baseline hematological profile (elevated eosinophil ratio, reduced lymphocyte ratio, elevated myoglobin) vs. Controls (patients receiving ICI therapy without myocarditis). Primary outcome: Occurrence of ICI-associated myocarditis (AUC 0.699, 95% CI 0.626-0.772, p=<0.001).

Key Result

A baseline model incorporating elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin predicted the occurrence of ICI-associated myocarditis with an AUC of 0.699.

Study Design

Type

Case-Control (n=196)

Multicenter

Structured PICO

Does a baseline hematological profile and combined ECG/enzymatic signature predict the occurrence and severity of ICI-associated myocarditis in patients receiving immune checkpoint inhibitors?

Population

196 patients with malignant tumors receiving immune checkpoint inhibitors (ICIs), comprising 98 cases of ICI-associated myocarditis (71 mild, 27 severe) and 98 controls. Mean age 57.83 years in cases, 66.33% male. Single-center cohort in China.

Intervention

Baseline hematological profile (elevated eosinophil ratio, reduced lymphocyte ratio, elevated myoglobin) and onset clinical profile (electrocardiographic abnormalities and marked creatine kinase elevation >10× ULN)

Comparator

Controls receiving ICI therapy without clinical suspicion or diagnostic evidence of ICI-associated myocarditis

Outcome

Occurrence of ICI-associated myocarditis and severity of myocarditis (mild vs. severe)safety

A baseline hematological profile and an onset ECG/enzymatic signature can help predict the occurrence and severity of ICI-associated myocarditis, enabling a two-stage risk stratification approach.

Main Result

Effect estimate: AUC 0.699 (95% CI 0.626-0.772)

p-value: p=<0.001

Limitations

Retrospective unmatched case-control design with inherent selection, observation, and information biases
Exclusion of patients with severe organ dysfunction prior to ICI initiation limits generalizability
Modest sample size, particularly the severe myocarditis subgroup (n=27), limiting statistical power
Single-center Chinese cohort treated predominantly with specific ICIs (sintilimab, toripalimab, tislelizumab) limits direct comparability

Abstract

Background Immune checkpoint inhibitor-associated myocarditis (ICI-associated myocarditis) is a rare but fatal immune-related adverse event. Early identification of high-risk patients remains challenging. This study aimed to identify risk factors and develop models for predicting both the occurrence and severity of ICI-associated myocarditis. Methods This retrospective unmatched case-control study stratified patients receiving ICIs into ICI-associated myocarditis (stratified into mild and severe subgroups) and controls. Comparative analysis of baseline and onset-phase data was performed, with logistic regression used to identify risk factors for the development of ICI-associated myocarditis and the severe myocarditis. Results In this cohort of 196 patients (98 myocarditis cases vs. 98 controls), a two-tiered risk stratification was established. Patients with myocarditis were further stratified into mild (n=71) and severe (n=27) subgroups. For predicting the occurrence of ICI-associated myocarditis, a baseline model incorporating elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin demonstrated an area under the ROC curve (AUC) of 0.699 (95% CI, 0.626-0.772, P 0.001). Upon onset, for predicting severe myocarditis, a model combining electrocardiographic abnormalities (T-wave changes, bundle branch blocks) and marked CK elevation (10× ULN) achieved a higher AUC of 0.769 (95% CI, 0.655-0.882, P 0.0001). Severe cases presented significantly earlier than mild cases (33 vs . 63 days, P = 0.043) and had higher rates of symptoms and concurrent immune-related adverse events. Conclusion A baseline profile of elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin collectively may help identify patients at risk for ICI-associated myocarditis. At myocarditis onset, a combination of specific electrocardiographic abnormalities and marked CK elevation may predict severe cases. These findings suggest a two-stage approach for early risk stratification and targeted management.

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Cite This Study

Zheng et al. (Tue,) conducted a case-control in ICI-associated myocarditis (n=196). Baseline hematological profile (elevated eosinophil ratio, reduced lymphocyte ratio, elevated myoglobin) vs. Controls (patients receiving ICI therapy without myocarditis) was evaluated on Occurrence of ICI-associated myocarditis (AUC 0.699, 95% CI 0.626-0.772, p=<0.001). A baseline model incorporating elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin predicted the occurrence of ICI-associated myocarditis with an AUC of 0.699.

synapsesocial.com/papers/6a137c933d45f5afe33c5164 https://doi.org/https://doi.org/10.3389/fimmu.2026.1762144

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