Shemer Asaf, Kivity Shaye, Shoenfeld Yehuda
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Zabludowicz Center for Autoimmune Diseases.
Transfusion. 2018 Feb;58(2):430-438. doi: 10.1111/trf.14427. Epub 2017 Nov 27.
Intravenous immunoglobulins (IVIG) are a biologic product originally developed to treat immunocompromised patients. In the past decades, there has been increased utilization of IVIG in autoimmune conditions. The objectives were to evaluate the clinical use of IVIG in the largest tertiary medical center in Israel and to determine top uses, estimate off-label usage, and assess consumption of this blood product.
We conducted an observational, retrospective study involving all patients who received IVIG from 2007 through 2015. Subjects were classified into five groups according to the indication for treatment.
A total of 1117 patients were identified. The mean (±SD) ages of adults and children were 55 ± 17 and 8 ± 7 years, respectively. Most common indication for treatment were immune-mediated conditions (54%), followed by secondary immunodeficiency (28%), primary immunodeficiency (10%), infections (4%), and miscellaneous (4%). The main immune-mediated conditions treated were hematologic disorders (305 patients, 27%), neurologic disorders (219 patients, 20%), and rheumatologic conditions (79 patients, 7%). Overall, a significant change in study period was observed in the number of patients (p < 0.001), consumption of IVIG (p < 0.01), and amount of IVIG administered per patient (p < 0.01). Fifty-six percent of the IVIG infusions were given for off-label Food and Drug Administration (FDA) indications.
In this study, we demonstrated that immune-mediated conditions represent the majority of indications for treatment with IVIG. We observed a 417% increase in IVIG administration (g) over time, attributed mainly to autoimmune diseases. Many indications are still off-label according to FDA recommendations.
静脉注射免疫球蛋白(IVIG)是一种最初用于治疗免疫功能低下患者的生物制品。在过去几十年中,IVIG在自身免疫性疾病中的应用有所增加。本研究旨在评估IVIG在以色列最大的三级医疗中心的临床使用情况,确定其主要用途,估计超说明书用药情况,并评估这种血液制品的消耗量。
我们进行了一项观察性回顾性研究,纳入了2007年至2015年期间接受IVIG治疗的所有患者。根据治疗指征将受试者分为五组。
共识别出1117例患者。成人和儿童的平均(±标准差)年龄分别为55±17岁和8±7岁。最常见的治疗指征是免疫介导性疾病(54%),其次是继发性免疫缺陷(28%)、原发性免疫缺陷(10%)、感染(4%)和其他(4%)。接受治疗的主要免疫介导性疾病包括血液系统疾病(305例患者,27%)、神经系统疾病(219例患者,20%)和风湿性疾病(79例患者,7%)。总体而言,研究期间患者数量(p<0.001)、IVIG消耗量(p<0.01)和每位患者的IVIG给药量(p<0.01)均出现显著变化。56%的IVIG输注用于食品药品监督管理局(FDA)批准的超说明书指征。
在本研究中,我们证明免疫介导性疾病是IVIG治疗的主要指征。我们观察到IVIG给药量(克)随时间增加了417%,主要归因于自身免疫性疾病。根据FDA的建议,许多指征仍属于超说明书用药。