Baumann Ulrich, Fasshauer Maria, Pausch Christine, Wittkowski Helmut, Hermann Corinna, Pittrow David, Borte Michael
Department of Paediatric Pulmonology, Allergy & Neonatology, Hannover Medical School, Hanover, Germany.
Hospital for Children & Adolescents, St. Georg Hospital, Leipzig, Germany; Academic Teaching Hospital of the University of Leipzig, Leipzig, Germany.
Immunotherapy. 2022 Feb;14(2):135-143. doi: 10.2217/imt-2021-0167. Epub 2021 Nov 8.
While facilitated subcutaneous immunoglobulin (fSCIG) has been evaluated in pediatric patients with primary immunodeficiency diseases in clinical trials, real-world data are lacking. This multicenter, retrospective, chart review study assessed fSCIG utilization in 30 patients less than 18 years old, with primary or secondary immunodeficiency diseases. Medical records were reviewed at fSCIG initiation and at 6 months. Most (90%) patients received their first fSCIG infusion at a medical facility; by 6 months, all fSCIG infusions were administered at home by the patient/caregiver, the majority infusing every 3-4 weeks into a single site. No serious adverse drug reactions occurred. This study supports the feasibility and tolerability of administering fSCIG at home to pediatric patients with immunodeficiencies. Clinical Trial Registration: DRKS00015436 (German Clinical Trials Register).
虽然皮下注射免疫球蛋白(fSCIG)已在原发性免疫缺陷疾病的儿科患者中进行了临床试验评估,但缺乏真实世界的数据。这项多中心、回顾性、病历审查研究评估了30名18岁以下原发性或继发性免疫缺陷疾病患者对fSCIG的使用情况。在开始使用fSCIG时和6个月时对病历进行了审查。大多数(90%)患者在医疗机构接受了首次fSCIG输注;到6个月时,所有fSCIG输注均由患者/护理人员在家中进行,大多数每3-4周在单一部位输注一次。未发生严重药物不良反应。本研究支持在家中对免疫缺陷儿科患者使用fSCIG的可行性和耐受性。临床试验注册:DRKS00015436(德国临床试验注册)。