Facilitated Subcutaneous Immunoglobulin Treatment in Patients with Immunodeficiencies: the FIGARO Study

• Published in: Journal of clinical immunology Vol. 43; no. 6; pp. 1259 - 1271
• Main Authors: Borte, Michael, Hanitsch, Leif G., Mahlaoui, Nizar, Fasshauer, Maria, Huscher, Dörte, Speletas, Matthaios, Dimou, Maria, Kamieniak, Marta, Hermann, Corinna, Pittrow, David, Milito, Cinzia
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.08.2023; Springer Nature B.V
• Subjects: Adults; Age; Biomedical and Life Sciences; Biomedicine; Clinical trials; Immune system; Immunodeficiency; Immunoglobulins; Immunology; Infectious Diseases; Internal Medicine; Medical Microbiology; Medical records; Older people; Original; Original Article; Patients; Pediatrics; Primary immunodeficiencies; Primary immunodeficiency disease; Utilization pattern; Secondary immunodeficiency disease; Immunoglobulin replacement therapy; Facilitated subcutaneous immunoglobulin
• ISSN: 0271-9142; 1573-2592
• DOI: 10.1007/s10875-023-01470-2

Purpose The FIGARO study aims to provide insights on real-world utilization and tolerability of facilitated subcutaneous immunoglobulin (fSCIG) for primary immunodeficiency disease (PID) or secondary immunodeficiency disease (SID). Methods This prospective, multicenter, observational study, evaluated medical records, charts, and diaries of patients who had received at least 1 fSCIG infusion for PID or SID. Data were analyzed by cohort (PID, SID) and age groups (pediatric [< 18 years], adult [18–64 years], older adult [≥ 65 years]). Patients were followed up to 36 months. Results The study enrolled 156 patients: 15 pediatric, 120 adult, 21 older-adult. Twelve-month follow-up data were available for 128 patients. fSCIG was mainly prescribed for PID among patients aged < 65 years and for SID among older adults. At inclusion, 75.6% received their fSCIG infusion at home, and 78.7% self-administered. Adults were more likely to receive their initial infusion at home and self-administer (81.7% and 86.6%, respectively) than pediatric patients (53.3% each) and older adults (57.1% and 52.4%, respectively). At 12 months, the proportion of patients infusing at home and self-administering increased to 85.8% and 88.2%. Regardless of age, most patients self-administered the full fSCIG dose at home every 3–4 weeks and required a single infusion site. The tolerability profile was consistent with previous pivotal trials. Acute severe bacterial infections occurred in 0%–9.1% of patients during follow-up visits (full cohort). Conclusions FIGARO confirms the feasibility, tolerability, and good infection control of fSCIG in PID and SID patients across the age spectrum in both the home-setting and medical facility. Trial registration number ClinicalTrials.gov NCT03054181