John T Anderson1, Vincent R Bonagura2,3, Juthaporn Cowan4, Connie Hsu5, S Shahzad Mustafa6,7, Niraj C Patel8, John M Routes9, Panida Sriaroon10, Donald C Vinh11, Jutta H Hofmann12, Michaela Praus13, Mikhail A Rojavin14. 1. Clinical Research Center of Alabama, 504 Brookwood Blvd Suite 250, Birmingham, AL, 35209, USA. JAnderson@alabamaallergy.com. 2. Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA. 3. Hofstra-NS-LIJ School of Medicine, Feinstein Institute for Medical Research, Rm. 1236, 350 Community Drive, Manhasset, NY, 11030, USA. 4. University of Ottawa, 501 Smyth Road, Box 223, Ottawa, ON, K1H8L6, Canada. 5. Allergy & Immunology Specialists, PLLC, 13575 W. Indian School Road, Suite 200, Litchfield Park, AZ, 85340, USA. 6. Rochester Regional Health, 222 Alexander Street, Suite 3000, Rochester, NY, 14607, USA. 7. University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY, 14642, USA. 8. Department of Pediatrics, Levine Children's Hospital, Atrium Health, 1000 Blythe Blvd, PO Box 32861, Charlotte, NC, 28232, USA. 9. Department of Pediatrics, Children's Hospital of Wisconsin, Medical College of Wisconsin, Medical College of Wisconsin, Milwaukee, 9000 W. Wisconsin Ave., Milwaukee, WI, 53226, USA. 10. University of South Florida, 140 7th Ave. South, CRI 4008, St. Petersburg, FL, 33701, USA. 11. McGill University Health Centre - Research Institute, 1001 Decarie Blvd, Block E, Rm EM3-3230 (Mail Drop: EM3-3211), Montreal, QC, H4A 3J1, Canada. 12. CSL Behring AG, Wankdorfstrasse 10, 3014, Bern, Switzerland. 13. CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041, Marburg, Germany. 14. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA, 19406, USA.
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.
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.
Entities:
Keywords:
IgPro20; Primary immunodeficiency (PID); high infusion flow rate; high infusion volume; pump-assisted infusion; subcutaneous Ig (SCIG)
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