Scientific article
Open access

Real-world use, safety, and patient experience of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases

Published inAdvances in therapy, vol. 40, no. 12, p. 5168-5187
Publication date2023-09-26

Introduction: The CORE study aimed to provide a detailed understanding of real-world immune globulin subcutaneous (human) 20% solution (Ig20Gly) utilization in patients with primary immunodeficiency diseases (PIDs) in Germany and Switzerland.

Methods: Patients with PIDs receiving a stable dose of any subcutaneous immunoglobulin for ≥ 3 months before enrollment were eligible for this multicenter (n = 5), phase 4, non-interventional, prospective, longitudinal cohort study. Besides baseline demographics and clinical characteristics, Ig20Gly utilization and safety data, and patient-reported outcomes (Life Quality Index/Treatment Satisfaction Questionnaire for Medication) were collected at baseline, 6 and 12 months. Statistical analysis was descriptive.

Results: Overall, 36 patients provided data at baseline [69.4% female; mean age: 41.6 years (7-78 years)]. Totals of 23 and 26 patients attended 6- and 12-month visits, respectively; 16 attended all three visits. One patient withdrew consent before 6-month follow-up. Median maximum infusion rates of Ig20Gly at baseline, 6 months, and 12 months were 26.7, 24.5, and 40.0 mL/h, respectively (10-60 mL/h). Infusion and dosing parameters remained consistent across time points: patients used a median of two infusion sites, primarily the abdomen, and all patients used an infusion pump; all but one infused at home and most self-administered Ig20Gly (80.8-83.3%) at once-weekly intervals (69.2-73.9%). During follow-up, 10 adverse events were reported: none were rated serious, while 2 were considered probably related to Ig20Gly. Total patient-reported outcome scores remained high throughout the study.

Conclusion: The CORE study provides real-world evidence of the flexibility, feasibility, safety, and tolerability of Ig20Gly infusions, at mostly weekly intervals, over 1 year in patients with PIDs.

  • Antibody deficiency syndromes
  • Ig20Gly
  • Immunoglobulin replacement therapy
  • Inborn errors of immunity
  • Observational
  • Primary immunodeficiency diseases
  • SCIG
  • Subcutaneous immunoglobulin
Citation (ISO format)
FASSHAUER, Maria et al. Real-world use, safety, and patient experience of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases. In: Advances in therapy, 2023, vol. 40, n° 12, p. 5168–5187. doi: 10.1007/s12325-023-02649-0
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ISSN of the journal0741-238X

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