Safety profile of sintilimab and establishment of a risk prediction model based on medical records of 337 cases

OBJECTIVE: To retrospectively analyze the clinical safety and adverse drug reactions (ADRs) of sintilimab, to evaluate risk factors for ADR occurrence, and to develop a predictive model to support individualized treatment strategies. MATERIALS AND METHODS: Medical records of patients who received sintilimab treatment in the period January 2021 to December 2022 were examined. Clinical data, including demographic characteristics, medication details, and ADRs were recorded and evaluated using univariate and multivariate logistic regression analyses to identify independent risk factors for sintilimab-induced ADRs. Variables such as gender, age, comorbidities, and treatment regimens were included. Receiver operating characteristic (ROC) curve analysis was performed to assess the predictive accuracy of individual and combined risk factors, enabling the safety profile of sintilimab to be established. RESULTS: A total of 337 cases were retrieved of which 208 (61.72%) referred to patients who experienced ADRs. Multivariate analysis identified combination drug therapy (OR = 25.670, 95% CI: 11.319 - 58.218, p < 0.001) and pretreatment baseline assessment (OR = 0.388, 95% CI: 0.191 - 0.789, p = 0.009) as two independent risk factors. The logistic model indicated that the combined prediction ability of these factors gave an area under the curve (AUC) of 0.800 (p < 0.001), which indicated prediction superiority compared to using the factors alone. Cross-validation using 115 cases demonstrated an accuracy of ~ 80.87% for the model. CONCLUSION: Combination therapy and pretreatment baseline assessment are independent risk factors for ADRs occurring during therapy with sintilimab. The combined predictive model derived shows high accuracy and may have value in predicting treatment risks and managing personalized medication.