Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.
Aim: A novel, Investigational Wearable Infusor (IWI) was evaluated in a randomized, controlled, crossover, open-label study to determine if its delivery of subcutaneous immunoglobulin (IgPro20) achieved a comparable area under the concentration-time curve (AUC) for immunoglobulin G (IgG) versus the Crono S-PID-50 infusion pump (CP). EudraCT: 2016-003798-16. Materials & methods: Patients with primary immunodeficiency (PID) were randomized to receive IgPro20 in Sequence 1 (CP/IWI) or 2 (IWI/CP). The primary end point was AUC for IgG during the final week of each 4-week period. Results: 23 patients were enrolled. Evaluation of area under the concentration-time curve from time 0 (pre-infusion) to 7 days after infusion (AUC0-7 days) (IWI: 1806 h*g/l; CP: 1829 h*g/l) and geometric mean ratio indicated comparable AUCs for IgG for both devices. Conclusion: Similar IgG exposure, indicated by AUC values, can be achieved with IgPro20 using the IWI or CP in PID.
Duke Scholars
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Related Subject Headings
- Wearable Electronic Devices
- Infusion Pumps
- Immunologic Deficiency Syndromes
- Immunoglobulins, Intravenous
- Immunoglobulin G
- Humans
- Cross-Over Studies
- 3211 Oncology and carcinogenesis
- 3204 Immunology
- 1115 Pharmacology and Pharmaceutical Sciences
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Wearable Electronic Devices
- Infusion Pumps
- Immunologic Deficiency Syndromes
- Immunoglobulins, Intravenous
- Immunoglobulin G
- Humans
- Cross-Over Studies
- 3211 Oncology and carcinogenesis
- 3204 Immunology
- 1115 Pharmacology and Pharmaceutical Sciences