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, Clinical Research Center of Alabama
Vincent R. Bonagura, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Juthaporn Cowan, University of Ottawa
Connie Hsu, Allergy & Immunology Specialists, Litchfield Park, AZ
S Shahzad Mustafa, Rochester Regional HealthFollow
Niraj C. Patel, Atrium Health
John M. Routes, Medical College of Wisconsin, Milwaukee
Panida Sriaroon, University of South Florida
Donald C. Vinh, McGill University Health Centre - Research Institute
Jutta H. Hofmann, CSL Behring AG, Bern, Switzerland
Michaela Praus, CSL Behring GmbH, Marburg, Germany
Mikhail A. Rojavin, CSL Behring LLC, King of Prussia, PA

Department

Allergy and Immunology

Document Type

Article

Publication Title

Journal of Clinical Immunology

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.

DOI

10.1007/s10875-020-00912-5

Volume

41

Issue

2

Publication Date

2-2021

PubMed ID

33409867

Recommended Citation

Anderson, J. T., Bonagura, V. R., Cowan, J., Hsu, C., Mustafa, S. S., Patel, N. C., Routes, J. M., Sriaroon, P., Vinh, D. C., Hofmann, J. H., Praus, M., & Rojavin, M. A. (2021). 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. Journal of Clinical Immunology, 41 (2) https://doi.org/10.1007/s10875-020-00912-5