Beydoun Said R, Sharma Khema R, Bassam Bassam A, Pulley Michael T, Shije Jeffrey Z, Kafal Ayman
Neuromuscular Division, Keck School of Medicine of University of Southern California (USC), Los Angeles, CA, United States.
Neurology Department, Miller School of Medicine, University of Miami, Miami, FL, United States.
Front Neurol. 2021 Mar 8;12:638816. doi: 10.3389/fneur.2021.638816. eCollection 2021.
Immunoglobulin (Ig) therapy is a first-line treatment for CIDP, which can be administered intravenously (IVIg) or subcutaneously (SCIg) and is often required long term. The differences between these modes of administration and how they can affect dosing strategies and treatment optimization need to be understood. In general, the efficacy of IVIg and SCIg appear comparable in CIDP, but SCIg may offer some safety and quality of life advantages to some patients. The differences in pharmacokinetic (PK) profile and infusion regimens account for many of the differences between IVIg and SCIg. IVIg is administered as a large bolus every 3-4 weeks resulting in cyclic fluctuations in Ig concentration that have been linked to systemic adverse events (AEs) (potentially caused by high Ig levels) and end of dose "wear-off" effects (potentially caused by low Ig concentration). SCIg is administered as a smaller weekly, or twice weekly, volume resulting in near steady-state Ig levels that have been linked to continuously maintained function and reduced systemic AEs, but an increase in local reactions at the infusion site. The reduced frequency of systemic AEs observed with SCIg is likely related to the avoidance of high Ig concentrations. Some small studies in immune-mediated neuropathies have focused on serum Ig data to evaluate its potential use as a biomarker to aid clinical decision-making. Analyzing dose data may help understand how establishing and monitoring patients' Ig concentration could aid dose optimization and the transition from IVIg to SCIg therapy.
免疫球蛋白(Ig)疗法是慢性炎性脱髓鞘性多发性神经病(CIDP)的一线治疗方法,可通过静脉注射(IVIg)或皮下注射(SCIg)给药,且通常需要长期使用。需要了解这些给药方式之间的差异以及它们如何影响给药策略和治疗优化。一般来说,IVIg和SCIg在CIDP中的疗效似乎相当,但SCIg可能对某些患者具有一些安全性和生活质量方面的优势。药代动力学(PK)特征和输注方案的差异是IVIg和SCIg之间许多差异的原因。IVIg每3 - 4周进行一次大剂量推注,导致Ig浓度出现周期性波动,这与全身不良事件(AE)(可能由高Ig水平引起)和剂量结束时的“药效消退”效应(可能由低Ig浓度引起)有关。SCIg以较小的每周一次或每周两次的剂量给药,导致Ig水平接近稳态,这与持续维持功能和减少全身AE有关,但会增加输注部位的局部反应。SCIg观察到的全身AE频率降低可能与避免高Ig浓度有关。一些关于免疫介导性神经病的小型研究集中在血清Ig数据上,以评估其作为生物标志物辅助临床决策的潜在用途。分析剂量数据可能有助于了解确定和监测患者的Ig浓度如何有助于剂量优化以及从IVIg治疗向SCIg治疗的转变。