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01-02-2021 | Primary Immunodeficiency | Original Article

Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study

Authors: John T. Anderson, Vincent R. Bonagura, Juthaporn Cowan, Connie Hsu, S. Shahzad Mustafa, Niraj C. Patel, John M. Routes, Panida Sriaroon, Donald C. Vinh, Jutta H. Hofmann, Michaela Praus, Mikhail A. Rojavin

Published in: Journal of Clinical Immunology | Issue 2/2021

Abstract

Purpose

To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra^®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency.

Methods

The Hizentra^® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25–50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25–100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated.

Results

Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study.

Conclusion

Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times.

Trial Registration

NCT03033745; registered January 27, 2017

Available only for authorised users

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Title: Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study
Authors: John T. Anderson
Vincent R. Bonagura
Juthaporn Cowan
Connie Hsu
S. Shahzad Mustafa
Niraj C. Patel
John M. Routes
Panida Sriaroon
Donald C. Vinh
Jutta H. Hofmann
Michaela Praus
Mikhail A. Rojavin
Publication date: 01-02-2021
Publisher: Springer US
Keyword: Primary Immunodeficiency
Published in: Journal of Clinical Immunology / Issue 2/2021
Print ISSN: 0271-9142
Electronic ISSN: 1573-2592
DOI: https://doi.org/10.1007/s10875-020-00912-5

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