ADVANCE-CIDP IVIG试验结果：使用GAMMAGARD LIQUID/Kiovig的10%静脉注射免疫球蛋白治疗慢性炎症性脱髓鞘性多发性神经根神经病的复发
The Results of ADVANCE-CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
作者信息
Pasnoor Mamatha, Anderson-Smits Colin, Levine Todd, Bril Vera, Solano Juan Marcos, Rejdak Konrad, Gamez Josep, Chroni Elisabeth, Casasnovas Carlos, Marchioni Enrico, Siciliano Gabriele, Cocito Dario, Sivakumar K, Rivero Alberto, Duff Kim, Greco Erin, Corbo Massimo, Hasan Shabbir, Dori Amir, Schmidt Jens, Wood Jamie, Li Zhaoyang, Ay Hakan
机构信息
University of Kansas Medical Center, Kansas City, Kansas, USA.
Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
出版信息
Eur J Neurol. 2025 Apr;32(4):e70110. doi: 10.1111/ene.70110.
BACKGROUND
ADVANCE-CIDP IVIG evaluated the efficacy and safety of immune globulin infusion (human) 10% solution (IVIG 10%; GAMMAGARD LIQUID, also known as Kiovig) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as a rescue treatment for patients relapsing during the ADVANCE-CIDP 1 trial.
METHODS
Open-label ADVANCE-CIDP IVIG included adult patients with confirmed CIDP relapse (≥ 1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability scores from pre-treatment baseline) during ADVANCE-CIDP 1, which assessed the efficacy and safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10%. Patients received an induction IVIG 10% dose (2 g/kg) followed by maintenance infusions at the same monthly equivalent dose of pre-randomization IVIG, 3-weekly for 6 months. The primary outcome was the responder rate (≥ 1-point decrease in adjusted INCAT scores at treatment cessation vs. pre-IVIG 10% baseline, in patients receiving placebo in ADVANCE-CIDP 1). Other outcomes included the responder rate across all patients relapsing on fSCIG 10% or placebo in ADVANCE-CIDP 1, time to functional improvement (≥ 1-point decrease in adjusted INCAT score), and change in adjusted INCAT scores and Rasch-built Overall Disability Scale (R-ODS) centile scores from pre-IVIG 10% baseline.
RESULTS
Overall, 20 patients received IVIG 10% (n = 4 [fSCIG 10%-relapse group]; n = 16 [placebo-relapse group]). Responder rate (95% confidence interval) was 100.0% (80.6%-100.0%) in the placebo-relapse group and 95.0% (76.4%-99.1%) in the overall-relapse population. Across all patients, median time to functional improvement was 25 days. At treatment cessation, mean changes from pre-IVIG 10% baseline in adjusted INCAT and R-ODS centile scores were -1.9 and 12.9, respectively.
CONCLUSIONS
IVIG 10% effectively treated CIDP relapse and improved functional abilities.
背景
ADVANCE-CIDP IVIG研究评估了10%免疫球蛋白输注液（人）（IVIG 10%；GAMMAGARD LIQUID，也称为Kiovig）在慢性炎症性脱髓鞘性多发性神经根神经病（CIDP）中作为ADVANCE-CIDP 1试验期间复发患者的挽救治疗的疗效和安全性。
方法
开放标签的ADVANCE-CIDP IVIG纳入了在ADVANCE-CIDP 1试验期间确诊为CIDP复发（调整后的炎症性神经病病因与治疗[INCAT]残疾评分较治疗前基线增加≥1分）的成年患者，ADVANCE-CIDP 1试验评估了透明质酸酶促进的皮下免疫球蛋白（fSCIG）10%的疗效和安全性。患者接受诱导剂量的IVIG 10%（2 g/kg），随后以与随机分组前IVIG相同的每月等效剂量进行维持输注，每3周一次，共6个月。主要结局是缓解率（在ADVANCE-CIDP 1试验中接受安慰剂治疗的患者中，治疗结束时调整后的INCAT评分较IVIG 10%治疗前基线降低≥1分）。其他结局包括ADVANCE-CIDP 1试验中所有在fSCIG 10%或安慰剂治疗下复发的患者的缓解率、功能改善时间（调整后的INCAT评分降低≥1分），以及调整后的INCAT评分和Rasch构建的总体残疾量表（R-ODS）百分位数得分相对于IVIG 10%治疗前基线的变化。
结果
总体而言，20例患者接受了IVIG 10%治疗（n = 4[fSCIG 10%复发组]；n = 16[安慰剂复发组]）。安慰剂复发组的缓解率（95%置信区间）为100.0%（80.6%-100.0%），总体复发人群的缓解率为95.0%（76.4%-99.1%）。在所有患者中，功能改善的中位时间为25天。治疗结束时，调整后的INCAT和R-ODS百分位数得分相对于IVIG 10%治疗前基线的平均变化分别为-1.9和12.9。
结论
IVIG 10%有效治疗CIDP复发并改善功能能力。
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