Skip to main content
Journal cover image

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.

Publication ,  Journal Article
Anderson, JT; Bonagura, VR; Cowan, J; Hsu, C; Mustafa, SS; Patel, NC; Routes, JM; Sriaroon, P; Vinh, DC; Hofmann, JH; Praus, M; Rojavin, MA
Published in: J Clin Immunol
February 2021

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

February 2021

Volume

41

Issue

2

Start / End Page

458 / 469

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Primary Immunodeficiency Diseases
  • Middle Aged
  • Male
  • Infusions, Subcutaneous
  • Infusion Pumps
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Immunoglobulin G
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Anderson, J. T., Bonagura, V. R., Cowan, J., Hsu, C., Mustafa, S. S., Patel, N. C., … 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. J Clin Immunol, 41(2), 458–469. https://doi.org/10.1007/s10875-020-00912-5
Anderson, John T., Vincent R. Bonagura, Juthaporn Cowan, Connie Hsu, S Shahzad Mustafa, Niraj C. Patel, John M. Routes, et al. “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.J Clin Immunol 41, no. 2 (February 2021): 458–69. https://doi.org/10.1007/s10875-020-00912-5.
Anderson, John T., et al. “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.J Clin Immunol, vol. 41, no. 2, Feb. 2021, pp. 458–69. Pubmed, doi:10.1007/s10875-020-00912-5.
Anderson JT, Bonagura VR, Cowan J, Hsu C, Mustafa SS, Patel NC, Routes JM, Sriaroon P, Vinh DC, Hofmann JH, Praus M, Rojavin MA. 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. J Clin Immunol. 2021 Feb;41(2):458–469.
Journal cover image

Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

February 2021

Volume

41

Issue

2

Start / End Page

458 / 469

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Primary Immunodeficiency Diseases
  • Middle Aged
  • Male
  • Infusions, Subcutaneous
  • Infusion Pumps
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Immunoglobulin G