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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 02;41(2):458-469

Date

01/08/2021

Pubmed ID

33409867

Pubmed Central ID

PMC7858210

DOI

10.1007/s10875-020-00912-5

Scopus ID

2-s2.0-85099072235

Abstract

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

METHODS: The HizentraA? 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 (Na??=a??15; 25-50A mL per injection site) and in the Pump-Assisted Flow Rate Cohort (Na??=a??18; 25-100A mL/h per injection site). Responder rates (percentage of patients who successfully completed a?Ya??75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated.

RESULTS: Responder rates were 86.7% (13/15, 25A mL) and 73.3% (11/15, 40 and 50A mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50A mL/h), 66.7% (12/18, 75A mL/h), and 61.1% (11/18, 100A mL/h) in the Flow Rate Cohort. Infusion compliance was a?Ya??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 50A mL and 100A 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.

Author List

Anderson JT, Bonagura VR, Cowan J, Hsu C, Mustafa SS, Patel NC, Routes JM, Sriaroon P, Vinh DC, Hofmann JH, Praus M, Rojavin MA

Author

John M. Routes MD Chief, Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Aged
Cohort Studies
Female
Humans
Immunoglobulin G
Immunoglobulins, Intravenous
Immunologic Deficiency Syndromes
Infusion Pumps
Infusions, Subcutaneous
Male
Middle Aged
Young Adult