Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial

IF 3.9 3区 医学 Q1 CLINICAL NEUROLOGY Journal of the Peripheral Nervous System Pub Date : 2023-06-14 DOI:10.1111/jns.12573
Vera Bril, Robert D. M. Hadden, Thomas H. Brannagan III, Michal Bar, Elisabeth Chroni, Konrad Rejdak, Alberto Rivero, Henning Andersen, Norman Latov, Todd Levine, Mamatha Pasnoor, Sabrina Sacconi, Nizar Souayah, Colin Anderson-Smits, Kim Duff, Erin Greco, Shabbir Hasan, Zhaoyang Li, Leman Yel, Hakan Ay
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引用次数: 1

Abstract

Background and Aims

ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse.

Methods

ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0–7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints.

Results

Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: −21.8% [−34.5%, −7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common.

Interpretation

fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.

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透明质酸酶促进的皮下免疫球蛋白10%作为慢性炎症性脱髓鞘性多根神经病变的维持治疗:ADVANCE-CIDP 1随机对照试验
背景与目的ADVANCE-CIDP 1评估促性皮下免疫球蛋白(fSCIG;人免疫球蛋白G 10%联合重组人透明质酸酶预防慢性炎症性脱髓鞘性多根神经病变(CIDP)复发的有效性和安全性。ADVANCE-CIDP 1是一项3期、双盲、安慰剂对照试验,在21个国家的54个地点进行。符合条件的成年人有明确或可能的CIDP,调整炎症性神经病变病因和治疗(INCAT)残疾评分为0-7分(含),并在筛查前接受稳定静脉注射免疫球蛋白(IVIG)≥12周。停止IVIG后,患者按1:1随机分配至fSCIG 10%或安慰剂组,持续6个月或直到复发/停药。10%的fSCIG以与预随机IVIG相同的剂量(或匹配的安慰剂体积)和间隔给予。主要结局是在修改意向治疗人群中经历CIDP复发的患者比例(与皮下治疗前基线相比,调整后的INCAT评分增加≥1分)。次要终点包括复发时间和安全性终点。结果132例患者(平均年龄54.4岁,56.1%为男性)接受fSCIG 10% (n = 62)或安慰剂(n = 70)治疗。与安慰剂相比,fSCIG组CIDP复发率降低10% (n = 6 [9.7%;95%置信区间4.5%,19.6%]vs n = 22 [31.4%;21.8%, 43.0%];绝对的区别:−−−34.5%,7.9%,21.8% p = .0045)。随着时间的推移,安慰剂组的复发概率比fSCIG组高10% (p = 0.002)。fSCIG组不良事件(ae)发生率为10%(79.0%)高于安慰剂组(57.1%),但严重(1.6% vs 8.6%)和严重(3.2% vs 7.1%)不良事件发生率较低。解释fSCIG预防CIDP复发的效果比安慰剂高10%,支持其作为维持CIDP治疗的潜力。
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来源期刊
CiteScore
6.10
自引率
7.90%
发文量
45
审稿时长
>12 weeks
期刊介绍: The Journal of the Peripheral Nervous System is the official journal of the Peripheral Nerve Society. Founded in 1996, it is the scientific journal of choice for clinicians, clinical scientists and basic neuroscientists interested in all aspects of biology and clinical research of peripheral nervous system disorders. The Journal of the Peripheral Nervous System is a peer-reviewed journal that publishes high quality articles on cell and molecular biology, genomics, neuropathic pain, clinical research, trials, and unique case reports on inherited and acquired peripheral neuropathies. Original articles are organized according to the topic in one of four specific areas: Mechanisms of Disease, Genetics, Clinical Research, and Clinical Trials. The journal also publishes regular review papers on hot topics and Special Issues on basic, clinical, or assembled research in the field of peripheral nervous system disorders. Authors interested in contributing a review-type article or a Special Issue should contact the Editorial Office to discuss the scope of the proposed article with the Editor-in-Chief.
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