Canessa Clementina, Iacopelli Jessica, Pecoraro Antonio, Spadaro Giuseppe, Matucci Andrea, Milito Cinzia, Vultaggio Alessandra, Agostini Carlo, Cinetto Francesco, Danieli Maria Giovanna, Gambini Simona, Marasco Carolina, Trizzino Antonino, Vacca Angelo, De Mattia Domenico, Martire Baldassarre, Plebani Alessandro, Di Gioacchino Mario, Gatta Alessia, Finocchi Andrea, Licciardi Francesco, Martino Silvana, De Carli Marco, Moschese Viviana, Azzari Chiara
1 Anna Meyer Children's Hospital, University of Florence, Florence, Italy.
2 Department of Translational Medical Sciences, Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy.
Int J Immunopathol Pharmacol. 2017 Mar;30(1):73-82. doi: 10.1177/0394632016681577. Epub 2016 Dec 7.
In patients with primary antibody deficiencies, subcutaneous administration of IgG (SCIG) replacement is effective, safe, well-tolerated, and can be self-administered at home. A new SCIG replacement at 20% concentration (Hizentra) has been developed and has replaced Vivaglobin (SCIG 16%). An observational prospective multi-centric open-label study, with retrospective comparison was conducted in 15 Italian centers, in order to investigate whether and to what extent switching to Hizentra would affect frequency of infusions, number of infusion sites, patients' satisfaction, and tolerability in patients previously treated with Vivaglobin or intravenous immunoglobulins (IVIG). Any variations of dosage, frequency and duration of the infusions, and of number of infusion sites induced by Hizentra with respect to the former treatment were recorded. Practical advantages and disadvantages of Hizentra, with respect to the medicinal product formerly used, and the variations in patients' therapy-related satisfaction were monitored by means of the TSQM (Treatment Satisfaction Questionnaire for Medication); number, frequency, and duration of infectious events and adverse effects were recorded. Eighty-two patients switched to Hizentra: 19 (23.2%) from IVIG and 63 (76.8%) from Vivaglobin. The mean interval between infusions was not affected by the shift (7.0 ± 2.0 days with previous treatment versus 7.1 ± 1.2 during Hizentra). A decrease in the number of infusion sites with Hizentra was recorded in 12 out of 56 patients for whom these data were available. At 6 months, 89.7% of patients were satisfied with Hizentra; no difference in terms of effectiveness, side effects, convenience, and global satisfaction was observed. No difference in the incidence of adverse events was reported.
在原发性抗体缺陷患者中，皮下注射免疫球蛋白（SCIG）替代治疗有效、安全、耐受性良好，且患者可在家自行给药。一种新的浓度为20%的SCIG替代产品（Hizentra）已研发出来，并已取代Vivaglobin（SCIG 16%）。在意大利的15个中心进行了一项观察性前瞻性多中心开放标签研究，并进行回顾性比较，以调查改用Hizentra是否会以及在多大程度上影响输注频率、输注部位数量、患者满意度以及先前接受Vivaglobin或静脉注射免疫球蛋白（IVIG）治疗的患者的耐受性。记录了Hizentra相对于先前治疗在输注剂量、频率和持续时间以及输注部位数量方面的任何变化。通过TSQM（药物治疗满意度问卷）监测Hizentra相对于先前使用的药品的实际优缺点以及患者治疗相关满意度的变化；记录感染事件和不良反应的数量、频率和持续时间。82名患者改用了Hizentra：19名（23.2%）从IVIG转换而来，63名（76.8%）从Vivaglobin转换而来。输注间隔时间不受转换的影响（先前治疗时为7.0±2.0天，使用Hizentra期间为7.1±1.2天）。在有可用数据的56名患者中，有12名患者记录到使用Hizentra后输注部位数量减少。6个月时，89.7%的患者对Hizentra满意；在有效性、副作用、便利性和总体满意度方面未观察到差异。不良事件发生率也未报告有差异。
