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

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 NCT03054181.

Keywords: Facilitated subcutaneous immunoglobulin; Immunoglobulin replacement therapy; Primary immunodeficiency disease; Secondary immunodeficiency disease; Utilization pattern.

Conflict of interest statement

Michael Borte’s institution has received research grant support from CSL Behring, Octapharma, and Baxalta. He has participated in advisory boards for CSL Behring, Octapharma, and Shire.

Leif G. Hanitsch received financial support for travelling and congress registration as well as honoraria for presentations and participation in advisory boards from Takeda, Shire, Baxalta, CSL Behring, Octapharma, and LFB.

Nizar Mahlaoui received support for CEREDIH research activities and towards participation in scientific advice, training, medical meetings, and international congresses from Grifols, Takeda, LFB Biomédicaments, Octapharma, and CSL Behring.

Maria Fasshauer’s institution has received research grant support from CSL Behring, Octapharma, and Baxalta/Shire. She has participated in advisory boards for Baxalta/Shire, has received honoraria for lectures from Shire and CSL-Behring, and has received travel grants from Octapharma until 2018.

Dörte Huscher has received travel compensation from Shire.

Matthaios Speletas’s institution has received a research grant from Shire.

Maria Dimou reports nothing to disclose.

Marta Kamieniak is an employee and shareholder of Takeda Development Center Americas, Inc.

David Pittrow reports personal fees from Actelion, Amgen, Daiichi Sankyo, Bayer, Aspen, Boehringer Ingelheim, Sanofi-Genzyme, Biogen, Janssen, Viatris, MSD, and Zambon all outside the submitted work. He has acted as a consultant for Baxalta.

Cinzia Milito has nothing to disclose.

Corinna Hermann was an employee of Baxalta Innovations GmbH, a member of the Takeda group of companies, and a Takeda stock owner.

© 2023. The Author(s).

Figures

Fig. 1

Patient disposition. “Intermediate missing” indicates that visits between available visits are missing. (e.g., a patient has no 12-month visit, but data was available for the 18-month visit.). PID, primary immunodeficiency disease; SID, secondary immunodeficiency disease

Fig. 2

fSCIG dose, infusion volume, and rate in the total population over 36 months of follow-up. n values represent number of patients at each visit; n values for each parameter may differ slightly due to missing data for that individual parameter. fSCIG, facilitated subcutaneous immunoglobulin

Fig. 3

fSCIG infusion interval in the total population over 36 months of follow-up. n values represent number of patients at each visit; n values for each parameter may differ slightly due to missing data for that individual parameter. *Across visits, information is available for n = 644 visits. fSCIG, facilitated subcutaneous immunoglobulin; NA, not applicable as the patients received only one fSCIG infusion to date

Fig. 4

fSCIG administration by age subgroup at inclusion and 12 months. a) Administration setting; b) Infusion administrator. Note: Among the 11 patients in the ramp-up phase at inclusion, 7 patients (63.6%) received their most recent fSCIG infusion at the doctor’s office and 4 patients (36.4%) at the hospital. Most patients (81.8% [9/11]) received their most recent infusion from a nurse, 1 patient (9.1%) from a physician, and 1 patient (9.1%) self-administered. Inner circle denotes at inclusion; outer circle denotes at 12 months. Data labels are number of patients. fSCIG, facilitated subcutaneous immunoglobulin

Fig. 5

Adverse reactions in the total population over 36 months of follow-up. Multiple reactions possible. aLocal (infusion site) includes infusion site erythema, inflammation, infusion site itching. bSystemic (generalized or non-infusion site) includes acute diarrhea, aseptic meningitis, chills, dizziness, drowsiness, fatigue, fever, fever chills, flu-like symptoms, headache, hypertension, itching, malaise, vasovagal reaction, weakness. ADR, adverse drug reactions; fSCIG, facilitated subcutaneous immunoglobulin