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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Michael Borte - , Leipzig University (Author)
  • Leif G. Hanitsch - , Charité – Universitätsmedizin Berlin (Author)
  • Nizar Mahlaoui - , Assistance publique – Hôpitaux de Paris (Author)
  • Maria Fasshauer - , Leipzig University (Author)
  • Dörte Huscher - , Charité – Universitätsmedizin Berlin (Author)
  • Matthaios Speletas - , University of Thessaly (Author)
  • Maria Dimou - , National and Kapodistrian University of Athens (Author)
  • Marta Kamieniak - , Takeda Development Center Americas (Author)
  • Corinna Hermann - , Baxalta Innovations GmbH (Author)
  • David Pittrow - , Medical Faculty Carl Gustav Carus, TUD Dresden University of Technology, Innovation Center Real World Evidence, Institute of Clinical Pharmacology (Author)
  • Cinzia Milito - , University of Rome La Sapienza (Author)

Abstract

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

Details

Original languageEnglish
Pages (from-to)1259-1271
Number of pages13
JournalJournal of clinical immunology
Volume43
Issue number6
Publication statusPublished - Aug 2023
Peer-reviewedYes
Externally publishedYes

External IDs

PubMed 37036560

Keywords

ASJC Scopus subject areas

Keywords

  • Facilitated subcutaneous immunoglobulin, Immunoglobulin replacement therapy, Primary immunodeficiency disease, Secondary immunodeficiency disease, Utilization pattern