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原发性和继发性免疫缺陷患者的免疫球蛋白替代疗法:输注方法对免疫球蛋白特异性生活质量认知和治疗满意度的影响。

Immunoglobulin replacement therapy in patients with primary and secondary immunodeficiencies: impact of infusion method on immunoglobulin-specific perceptions of quality of life and treatment satisfaction.

作者信息

Mallick Rajiv, Hahn Noemi, Scalchunes Christopher

机构信息

CSL Behring, King of Prussia, PA, USA.

Bryter Inc, New York, NY, USA.

出版信息

Allergy Asthma Clin Immunol. 2025 Jan 7;21(1):2. doi: 10.1186/s13223-024-00939-y.

Abstract

BACKGROUND

Immunoglobulin replacement therapy (IgRT) is the current standard of care for primary antibody deficiency patients (majority of all primary immunodeficiency (PID) diseases), with growing real-world evidence supporting use for secondary immunodeficiency (SID) patients. Infusion methods and practices can affect patients' satisfaction with their treatment and perception of their health-related quality of life.

METHODS

An online survey of US patients with PID and SID was conducted. This research investigates primarily the impact of two IgRT infusion methods, intravenous immunoglobulin therapy (IVIG) and subcutaneous immunoglobulin (SCIG), on the patient reported outcome (PRO) Life Quality Index (LQI) tool. Patient reported infusion time efficiency, physical and mental health (PROMIS GPH-2 and PROMIS GMH-2 respectively), patient acceptability of their symptom state (PASS), upper extremity disability (Quick DASH) and general health perception (via the GHP) are also investigated.

RESULTS

Responses of 990 patients (391 IVIG and 598 SCIG) were analyzed. The median total LQI score amongst SCIG patients (84.7) was higher than IVIG patients (81.9) (p < 0.001), and was significantly higher on 3 out of 4 sub-domains of the LQI. SCIG patients scored higher on items that are related to convenience and reported less interference with everyday life: "Are convenient", "Are scheduled according to my convenience", "Do not interfere with my work/school" and "Require very little time and cost". However, there was no significant difference between the two patient cohorts on other, non-IG specific PROs (PASS, PROMIS GPH-2 and GMH-2 and Quick DASH). Patient reported time per infusion was lower for SCIG infusions than IVIG infusions (pre-infusion time; 22 min vs. 63 min, p < 0.001, infusion time; 120 min vs. 240 min, p < 0.001, post-infusion time; 9 min vs. 31 min, p < 0.001). IVIG patients also reported more interference with everyday life than SCIG patients (82 vs. 86, p < 0.001).

CONCLUSIONS

The significantly higher LQI scores for patients receiving SCIG than those receiving IVIG confirms existing evidence that substitution of SCIG for IVIG may favorably impact immunoglobulin specific perceptions of quality of life and treatment satisfaction for appropriately selected patients. Our evidence on infusion times indicates similar improvement may be possible on infusion time efficiency.

摘要

背景

免疫球蛋白替代疗法(IgRT)是原发性抗体缺陷患者(所有原发性免疫缺陷(PID)疾病中的大多数)当前的标准治疗方法,越来越多的真实世界证据支持其用于继发性免疫缺陷(SID)患者。输注方法和实践会影响患者对治疗的满意度及其对健康相关生活质量的认知。

方法

对美国的PID和SID患者进行了一项在线调查。本研究主要调查两种IgRT输注方法,即静脉注射免疫球蛋白疗法(IVIG)和皮下免疫球蛋白(SCIG),对患者报告结局(PRO)生活质量指数(LQI)工具的影响。还调查了患者报告的输注时间效率、身心健康(分别为PROMIS GPH - 2和PROMIS GMH - 2)、患者对其症状状态的可接受性(PASS)、上肢残疾(Quick DASH)和总体健康认知(通过GHP)。

结果

分析了990名患者的回复(391名接受IVIG,598名接受SCIG)。SCIG患者的LQI总分中位数(84.7)高于IVIG患者(81.9)(p < 0.001),并且在LQI的4个亚领域中的3个上显著更高。SCIG患者在与便利性相关的项目上得分更高,并且报告对日常生活的干扰更少:“方便”、“根据我的方便安排”、“不干扰我的工作/学习”以及“所需时间和成本很少”。然而,在其他非IG特异性的PRO方面(PASS、PROMIS GPH - 2和GMH - 2以及Quick DASH),两个患者队列之间没有显著差异。患者报告的每次输注时间,SCIG输注比IVIG输注更低(输注前时间;22分钟对63分钟,p < 0.001,输注时间;120分钟对240分钟,p < 0.001,输注后时间;9分钟对31分钟,p < 0.001)。IVIG患者也报告比SCIG患者对日常生活的干扰更多(82对86,p < 0.001)。

结论

接受SCIG的患者的LQI得分显著高于接受IVIG的患者,这证实了现有证据,即对于适当选择的患者,用SCIG替代IVIG可能会对免疫球蛋白特异性的生活质量认知和治疗满意度产生有利影响。我们关于输注时间的证据表明,在输注时间效率方面可能会有类似的改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2d1/11706029/3cdc3638acc0/13223_2024_939_Fig1_HTML.jpg

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