Insights into Facilitated Subcutaneous Immunoglobulin Use in Patients with Secondary Immunodeficiency Diseases: A FIGARO Subgroup Analysis

Author:

Dimou Maria1ORCID,Speletas Matthaios2ORCID,Milito Cinzia3ORCID,Pyzik Aleksandra4,Huscher Dörte5ORCID,Kamieniak Marta6ORCID,Pittrow David78ORCID,Borte Michael9

Affiliation:

1. First Department of Propaedeutic Internal Medicine, National & Kapodistrian University of Athens Medical School, General Hospital “LAIKO”, 11527 Athens, Greece

2. School of Health Sciences, Department of Immunology and Histocompatibility, Faculty of Medicine, University of Thessaly, GR-41500 Larissa, Greece

3. Department of Molecular Medicine, Sapienza University of Rome, 00161 Rome, Italy

4. Department of Clinical Immunology, Center of Oncology St. Jana, 20-090 Lublin, Poland

5. Institute of Biometry and Clinical Epidemiology, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany

6. Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA

7. Institute for Clinical Pharmacology, Medical Faculty, Technical University of Dresden, 01307 Dresden, Germany

8. Innovation Center Real World Evidence, GWT-TUD GmbH, 01067 Dresden, Germany

9. Hospital for Children and Adolescents, St. Georg Hospital, Academic Teaching Hospital of the University of Leipzig, IDCL (ImmunoDeficiency Center Leipzig), 04129 Leipzig, Germany

Abstract

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.

Funder

GWT-TUD GmbH, Dresden, Germany

Baxalta Innovations GmbH

Takeda Pharmaceuticals International AG

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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