Department of Pediatrics, Université Catholique de Louvain, CHU Mont-Godinne, 5530 Yvoir, Belgium.
Pediatrics. 2014 Jan;133(1):e154-62. doi: 10.1542/peds.2013-1155. Epub 2013 Dec 23.
Clinical data are lacking on optimal levels of specific antipneumococcal antibodies (PnPsAbs) in patients with primary immunodeficiency (PID) receiving intravenous immunoglobulin (IVIG) replacement. Objectives were to conduct a prospective multicenter study providing data on total immunoglobulin G (IgG) and peak/trough levels of PnPsAbs specifically targeting the 16 most prevalent pneumococcal serotypes in IVIG-treated children with PID; to compare trough PnPsAb levels with those measured in healthy adults and the IVIG product; and to evaluate PnPsAb protection correlates with thresholds based on World Health Organization.
Patients received 7 consecutive IVIG infusions. Total IgG and PnPsAb levels were determined on plasma samples obtained before and after infusion.
Twenty-two children with PID were treated with IVIG (mean weekly dose: 0.10 g/kg). The mean trough and peak levels of total IgG were 7.77 and 13.93 g/L, respectively. Trough and peak geometric mean concentrations and distribution curves differed between serotypes and showed wide dispersion (0.17-7.96 µg/mL). In patients (89%-100%), antibodies against most serotypes reached trough levels ≥ 0.2 µg/mL, a threshold considered protective against invasive pneumococcal infection. For several serotypes, trough levels reached ≥ 1.0 to 1.3 µg/mL, the level found in adults. Trough geometric mean concentrations correlated well with the PnPsAb contents of the IVIG product.
In IVIG-treated children with PID, protective PnPsAb levels for most pathogenic serotypes were obtained. A correlation was observed between PnPsAb levels in patients and in the IVIG product. This offers the potential to improve infection prevention by adapting the IVIG product and dose according to epidemiology.
在接受静脉注射免疫球蛋白 (IVIG) 替代治疗的原发性免疫缺陷 (PID) 患者中，临床数据缺乏针对特定肺炎球菌抗体 (PnPsAbs) 的最佳水平。目的是进行一项前瞻性多中心研究，提供关于 PID 患儿接受 IVIG 治疗后针对最常见的 16 种肺炎球菌血清型的总免疫球蛋白 G (IgG) 和峰值/谷值 PnPsAbs 数据；比较谷值 PnPsAb 水平与健康成人和 IVIG 产品的测量值；并评估 PnPsAb 保护相关性与基于世界卫生组织的阈值。
患者接受了 7 次连续的 IVIG 输注。在输注前后的血浆样本中测定总 IgG 和 PnPsAb 水平。
22 名 PID 患儿接受 IVIG 治疗（平均每周剂量：0.10 g/kg）。总 IgG 的谷值和峰值水平分别为 7.77 和 13.93 g/L。各血清型的谷值和峰值几何均数浓度和分布曲线不同，且离散度较大（0.17-7.96 µg/mL）。在患者中（89%-100%），针对大多数血清型的抗体达到了谷值≥0.2 µg/mL，这是被认为可预防侵袭性肺炎球菌感染的阈值。对于几种血清型，谷值达到了≥1.0 至 1.3 µg/mL，这是成人中发现的水平。谷值几何均数浓度与 IVIG 产品中的 PnPsAb 含量密切相关。
在接受 IVIG 治疗的 PID 患儿中，获得了针对大多数致病性血清型的保护性 PnPsAb 水平。患者和 IVIG 产品中的 PnPsAb 水平之间存在相关性。这为根据流行病学调整 IVIG 产品和剂量以预防感染提供了潜力。
