Safety assessment and risk factor analysis of PD-1 immunotherapy in a cohort of 385 patients

doi:10.19803/j.1672-8629.20230304

Abstract

Abstract: Objective To explore the risk factors of domestic PD-1 related ADR, and provide prognostic indexes and experience for the safety of PD-1 immunotherapy. Methods Collected and recorded domestic PD-1 cases from June 2020 to December 2022 in our hospital: Gender, age, body mass index, tumor type, underlying disease, PD-1variety. etc. Followed up for at least two treatment cycles, identified and evaluated the type and degree of irAE. Then evaluated with univariate and multivariate Logistic regression analysis. Results A total of 385 cases were collected, including 134(34.81%) irAE, 251(65.19%) non-irAE, and 29(7.53%) ≥grade 3 irAE. Univariate analysis showed that the incidence of irAE was related to age, smoking, type of tumor and PD-1(P<0.05). Multivariate analysis showed that age<65 increased 1.590 times(95%CI: 1.006, 2.512), smoking increased 1.920 times(95%CI: 1.021, 3.611), respiratory diseases were 2.061 times (95%CI: 1.205, 3.527) more likely to develop irAE, Carrilizul had a higher risk than sindilid, Tirelizul and triripril (P<0.05). Conclusion Age<65, smoking and respiratory tumor is the higher risk factors of irAE of PD-1, the short-term irAE rate of Carrilizumab is higher, more attention should be paid to monitoring such patients and offering irAE treatment in time.

Key words: PD-1, adverse drug reactions, immune-related adverse effects, incidence rate, safety assessment, risk factors, malignant tumor

CLC Number:

R979.1

YANG Bo, WANG Mengjiao, HU Lili, WANG Laicheng, LI Qian, KONG Feifei, LYU Dongmei, SHEN Jiani. Safety assessment and risk factor analysis of PD-1 immunotherapy in a cohort of 385 patients[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 447-450.

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