Abstract：
OBJECTIVE: The objective of this study was to analyze the changes in plasma fibrinogen (FIB) levels during tocilizumab (TCZ) treatment in patients with rheumatic diseases, to clarify the incidence of hypofibrinogenemia and its possible risk factors, and to establish a nomogram model for predicting the probability of hypofibrinogenemia in rheumatoid arthritis (RA) patients treated with TCZ.
METHODS: Clinical data of patients treated with TCZ at the Department of Rheumatology and Immunology, the First Affiliated Hospital of Xi\'an Jiaotong University from January 2014 to October 2021 were retrospectively analyzed to observe the incidence of hypofibrinogenemia in several rheumatic diseases at different time points. The risk factor of hypofibrinogenemia in RA patients treated with TCZ was determined by using Cox regression analysis. Based on the results of Cox regression analysis, a nomogram for predicting the probability of hypofibrinogenemia in rheumatoid arthritis (RA) patients treated with TCZ was established and validated through RStudio software.
RESULTS: A total of 83 TCZ-treated patients were enrolled in this study, and 32 (38.55%) patients developed hypofibrinogenemia during TCZ treatment. There were 8 males and 24 females in the FIB-reduced group, with an average age of 44.88 ± 18.39 years. Hypofibrinogenemia was most common in TCZ-treated patients with takayasu arteritis (TA) and RA. Hypofibrinogenemia typically occured within 3 months after TCZ treatment. In RA patients treated with TCZ, platelet distribution width, parathyroid hormone, bone mineral density, tender joint count, and swollen joint count were independent risk factors for the occurrence of hypofibrinogenemia. The nomogram based on the above risk factors could effectively predict the probability of hypofibrinogenemia in RA patients receiving TCZ.
CONCLUSIONS: Although bleeding symptoms were not observed in this study, the incidence of hypofibrinogenemia remained high after TCZ treatment, usually occurring within 3 months of treatment. Therefore, it is necessary to monitor FIB levels during TCZ treatment. In addition, clinicians can use the nomogram model developed from this study to predict the incidence of hypofibrinogenemia after TCZ treatment in RA patients. Key Points • Hypofibrinogenemia often occurs during TCZ treatment for rheumatic diseases. • PDW, PTH, BMD, tender joint count, and swollen joint count are risk factors for the occurrence of hypofibrinogenemia. • It is necessary to monitor FIB levels during TCZ treatment to avoid bleeding tendency.
METHODS: Clinical data of patients treated with TCZ at the Department of Rheumatology and Immunology, the First Affiliated Hospital of Xi\'an Jiaotong University from January 2014 to October 2021 were retrospectively analyzed to observe the incidence of hypofibrinogenemia in several rheumatic diseases at different time points. The risk factor of hypofibrinogenemia in RA patients treated with TCZ was determined by using Cox regression analysis. Based on the results of Cox regression analysis, a nomogram for predicting the probability of hypofibrinogenemia in rheumatoid arthritis (RA) patients treated with TCZ was established and validated through RStudio software.
RESULTS: A total of 83 TCZ-treated patients were enrolled in this study, and 32 (38.55%) patients developed hypofibrinogenemia during TCZ treatment. There were 8 males and 24 females in the FIB-reduced group, with an average age of 44.88 ± 18.39 years. Hypofibrinogenemia was most common in TCZ-treated patients with takayasu arteritis (TA) and RA. Hypofibrinogenemia typically occured within 3 months after TCZ treatment. In RA patients treated with TCZ, platelet distribution width, parathyroid hormone, bone mineral density, tender joint count, and swollen joint count were independent risk factors for the occurrence of hypofibrinogenemia. The nomogram based on the above risk factors could effectively predict the probability of hypofibrinogenemia in RA patients receiving TCZ.
CONCLUSIONS: Although bleeding symptoms were not observed in this study, the incidence of hypofibrinogenemia remained high after TCZ treatment, usually occurring within 3 months of treatment. Therefore, it is necessary to monitor FIB levels during TCZ treatment. In addition, clinicians can use the nomogram model developed from this study to predict the incidence of hypofibrinogenemia after TCZ treatment in RA patients. Key Points • Hypofibrinogenemia often occurs during TCZ treatment for rheumatic diseases. • PDW, PTH, BMD, tender joint count, and swollen joint count are risk factors for the occurrence of hypofibrinogenemia. • It is necessary to monitor FIB levels during TCZ treatment to avoid bleeding tendency.
摘要：
目的：本研究的目的是分析风湿性疾病患者在托珠单抗（TCZ）治疗期间血浆纤维蛋白原（FIB）水平的变化，阐明低纤维蛋白原血症的发生率及其可能的危险因素，并建立一个列线图模型，用于预测接受TCZ治疗的类风湿关节炎（RA）患者的低纤维蛋白原血症概率。
方法：在风湿免疫科接受TCZ治疗的患者的临床资料，回顾性分析西安交通大学第一附属医院2014年1月至2021年10月几种风湿性疾病不同时间点的低纤维蛋白原血症发生率。采用Cox回归分析确定TCZ治疗的RA患者发生低纤维蛋白原血症的危险因素。根据Cox回归分析的结果，通过RStudio软件建立并验证了预测接受TCZ治疗的类风湿关节炎(RA)患者出现低纤维蛋白原血症概率的列线图.
结果：本研究共纳入83例接受TCZ治疗的患者，32例(38.55%)患者在TCZ治疗期间出现低纤维蛋白原血症。FIB减少组中有8名男性和24名女性，平均年龄44.88±18.39岁。低纤维蛋白原血症在TCZ治疗的大动脉炎（TA）和RA患者中最常见。低纤维蛋白原血症通常发生在TCZ治疗后3个月内。在接受TCZ治疗的RA患者中，血小板分布宽度,甲状旁腺激素,骨矿物质密度，招标接头计数，关节肿胀是发生低纤维蛋白原血症的独立危险因素。基于上述危险因素的列线图可以有效预测接受TCZ的RA患者发生低纤维蛋白原血症的概率。
结论：虽然本研究未观察到出血症状，TCZ治疗后低纤维蛋白原血症的发生率仍然很高，通常发生在治疗后3个月内。因此,在TCZ治疗期间有必要监测FIB水平。此外,临床医师可以使用本研究建立的列线图模型来预测RA患者TCZ治疗后低纤维蛋白原血症的发生率.要点•在TCZ治疗风湿性疾病期间经常发生低纤维蛋白原血症。•PDW,PTH,BMD,招标接头计数，关节肿胀是低纤维蛋白原血症发生的危险因素。•有必要在TCZ治疗期间监测FIB水平以避免出血倾向。
方法：在风湿免疫科接受TCZ治疗的患者的临床资料，回顾性分析西安交通大学第一附属医院2014年1月至2021年10月几种风湿性疾病不同时间点的低纤维蛋白原血症发生率。采用Cox回归分析确定TCZ治疗的RA患者发生低纤维蛋白原血症的危险因素。根据Cox回归分析的结果，通过RStudio软件建立并验证了预测接受TCZ治疗的类风湿关节炎(RA)患者出现低纤维蛋白原血症概率的列线图.
结果：本研究共纳入83例接受TCZ治疗的患者，32例(38.55%)患者在TCZ治疗期间出现低纤维蛋白原血症。FIB减少组中有8名男性和24名女性，平均年龄44.88±18.39岁。低纤维蛋白原血症在TCZ治疗的大动脉炎（TA）和RA患者中最常见。低纤维蛋白原血症通常发生在TCZ治疗后3个月内。在接受TCZ治疗的RA患者中，血小板分布宽度,甲状旁腺激素,骨矿物质密度，招标接头计数，关节肿胀是发生低纤维蛋白原血症的独立危险因素。基于上述危险因素的列线图可以有效预测接受TCZ的RA患者发生低纤维蛋白原血症的概率。
结论：虽然本研究未观察到出血症状，TCZ治疗后低纤维蛋白原血症的发生率仍然很高，通常发生在治疗后3个月内。因此,在TCZ治疗期间有必要监测FIB水平。此外,临床医师可以使用本研究建立的列线图模型来预测RA患者TCZ治疗后低纤维蛋白原血症的发生率.要点•在TCZ治疗风湿性疾病期间经常发生低纤维蛋白原血症。•PDW,PTH,BMD,招标接头计数，关节肿胀是低纤维蛋白原血症发生的危险因素。•有必要在TCZ治疗期间监测FIB水平以避免出血倾向。
