Medical Day-Unit, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Section of Clinical Immunology and Infectious Diseases, Department of Rheumatology, Dermatology and Infectious Diseases, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Front Immunol. 2021 Apr 27;12:670547. doi: 10.3389/fimmu.2021.670547. eCollection 2021.
Immunoglobulin replacement therapy with facilitated subcutaneous immunoglobulin (fSCIg) can be self-administrated at home and given at longer intervals compared to subcutaneous immunoglobulin (SCIg) therapy, but real-word experience of home-based fSCIg therapy is limited. Herein we present our real-word clinical experiences with home-based fSCIg therapy using a three-step ramp-up schedule. We registered data from all patients with immunodeficiency starting fSCIg from 01.01.2017 to 31.12.2019. For comparison we also included patients starting conventional SCIg training. Fifty-four patients followed for a median of 18 months (IQR 12, range 0-40), received fSCIg training, and 84 patients received conventional SCIg training. Out of 54 patients starting with fSCIg, 41 patients had previous experience with conventional SCIg therapy, and the main reason for starting fSCIg was 'longer intervals between therapies' (n=48). We found an increase in training requirement for fSCIg (3 ± 1 [2-9] days) compared to conventional SCIg (2 ± 0 [1-7] days), < 0.001 (median ± IQR, [range]). For fSCIg training, IgG levels were stable from baseline (8.9 ± 2.3 g/L), 3-6 months (10.2 ± 2.2 g/L) and 9-12 months (9.9 ± 2.3 g/L), = 0.11 (mean ± SD). The most common side-effect was: 'rubor around injection site' (n=48, 89%). No patients experienced severe adverse events (grade 3-4). Thirteen patients (24%) discontinued fSCIg therapy due to local adverse events (n=9), cognitive/psychological difficulties (n=6) and/or systemic adverse events (n=3). In conclusion, fSCIg training using a three-step ramp-up schedule is safe and well tolerated by the majority of patients, but requires longer training time compared to conventional SCIg.
免疫球蛋白替代疗法采用经皮免疫球蛋白（fSCIg），与皮下免疫球蛋白（SCIg）治疗相比，可在家中自行给药且间隔时间更长，但基于真实世界的 fSCIg 家庭治疗经验有限。在此，我们报告了使用三步递增方案进行基于家庭的 fSCIg 治疗的真实临床经验。我们从 2017 年 1 月 1 日至 2019 年 12 月 31 日，登记了所有开始 fSCIg 治疗的免疫缺陷患者的数据。为了进行比较，我们还包括了开始常规 SCIg 训练的患者。54 例患者中位随访 18 个月（IQR 12，范围 0-40），接受 fSCIg 训练，84 例患者接受常规 SCIg 训练。在开始 fSCIg 的 54 例患者中，41 例患者有接受常规 SCIg 治疗的既往经验，开始 fSCIg 的主要原因是“治疗间隔时间更长”（n=48）。我们发现与常规 SCIg 相比，fSCIg 的培训需求增加（3 ± 1 [2-9] 天），<0.001（中位数±IQR[范围]）。对于 fSCIg 训练，IgG 水平从基线（8.9 ± 2.3 g/L）、3-6 个月（10.2 ± 2.2 g/L）和 9-12 个月（9.9 ± 2.3 g/L）稳定，=0.11（平均值±SD）。最常见的副作用是：“注射部位红肿”（n=48，89%）。无患者发生严重不良事件（3-4 级）。由于局部不良事件（n=9）、认知/心理困难（n=6）和/或全身不良事件（n=3），13 例（24%）患者停止了 fSCIg 治疗。总之，采用三步递增方案的 fSCIg 训练安全且大多数患者可耐受，但与常规 SCIg 相比，需要更长的培训时间。
