The Facilitated Immunoglobulin Administration Registry And Outcomes (FIGARO) Study was a European, multicenter, prospective, observational study conducted across Europe designed to provide insights on the clinical use and tolerability of facilitated subcutaneous immunoglobulin (fSCIG). Data herein are reported for the cohort of patients with secondary immunodeficiency (SID), with a subgroup analysis by age. The SID cohort included 31 patients: 1 pediatric, 15 adult, and 15 older adult patients. Over the 36-month observation period, the median monthly dose of fSCIG (30 g) and median monthly infusion volume per patient (300 mL) remained constant in both adult-age cohorts. Serum trough levels tended to increase over time. Most patients required only one infusion site and could receive the full dose every 3–4 weeks. There was a trend toward self-administration at home. In the adult group, infusion site inflammation and headache were reported at the inclusion visit (n= 1 each), with no adverse drug reactions reported at any of the follow-up visits. No acute severe bacterial infections were reported during the study follow-up. These results demonstrate the feasibility and tolerability of fSCIG use in patients with SID and the flexibility of administration settings including self-administration at home in patients aged ≥65 years.
便利免疫球蛋白给药登记与结局（FIGARO）研究是一项在欧洲开展的多中心、前瞻性、观察性研究，旨在深入了解便利皮下免疫球蛋白（fSCIG）的临床应用及耐受性。本文报告了继发性免疫缺陷（SID）患者队列的数据，并按年龄进行了亚组分析。SID队列共纳入31例患者，包括1例儿童患者、15例成年患者和15例老年患者。在36个月的观察期内，两个成年年龄组患者每月fSCIG中位剂量（30 g）及每月中位输注体积（300 mL）均保持稳定。血清谷浓度随时间推移呈上升趋势。多数患者仅需一个输注部位，且可每3-4周接受全剂量给药。家庭自我给药模式呈现增长趋势。成年组患者在入组访视时报告了输注部位炎症和头痛（各1例），所有随访访视中均未报告药物不良反应。研究随访期间未报告急性严重细菌感染。这些结果证实了fSCIG在SID患者中应用的可行性与耐受性，以及在≥65岁患者中实施家庭自我给药等多种给药场景的灵活性。
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