Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Pr
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ORIGINAL ARTICLE
Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study Juthaporn Cowan 1 & Vincent R. Bonagura 2,3 & Patricia L. Lugar 4 & Paul J. Maglione 5 & Niraj C. Patel 6 & Donald C. Vinh 7 & Jutta H. Hofmann 8 & Michaela Praus 9 & Mikhail A. Rojavin 10 Received: 15 June 2020 / Accepted: 25 September 2020 # The Author(s) 2020
Abstract Purpose To evaluate the safety and tolerability of IgPro20 manual push (also known as rapid push) infusions at flow rates of 0.5– 2.0 mL/min. Methods Patients with primary immunodeficiency (PID) with previous experience administering IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) were enrolled in the Hizentra® Label Optimization (HILO) study (NCT03033745) and assigned to Pump-assisted Volume Cohort, Pump-assisted Flow Rate Cohort, or Manual Push Flow Rate Cohort; this report describes the latter. Patients administered IgPro20 via manual push at 0.5, 1.0, and 2.0 mL/min/site for 4 weeks each. Responder rates (percentage of patients who completed a predefined minimum number of infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. Results Sixteen patients were treated; 2 patients (12.5%) discontinued at the 1.0-mL/min level (unrelated to treatment). Responder rates were 100%, 100%, and 87.5% at 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Mean weekly infusion duration decreased from 103–108 to 23–28 min at the 0.5- and 2.0-mL/min flow rates, respectively. Rates of treatment-related treatment-emergent adverse events (TEAEs) per infusion were 0.023, 0.082, and 0.025 for the 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Most TEAEs were mild local reactions and tolerability (infusions without severe local reactions/total infusions) was 100% across flow rate levels. Serum IgG levels (mean [SD]) were similar at study start (9.36 [2.53] g/L) and end (9.58 [2.12] g/L). Conclusions Subcutaneous IgPro20 manual push infusions at flow rates up to 2.0 mL/min were well tolerated and reduced infusion time in treatment-experienced patients with PID. Trial Registration NCT03033745
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10875-020-00876-6) contains supplementary material, which is available to authorized users. * Mikhail A. Rojavin [email protected] 1
University of Ottawa, 501 Smyth Road, Box 223, Ottawa, ON K1H 8L6, Canada
2
Donald and Barbara Zucker School of Medicine at Hofstra/ Northwell, Great Neck, NY, USA
3
Feinstein Institute for Medical Research, Hofstra-NS-LIJ School of Medicine, Rm. 1236, 350 Community Drive, Manhasset, NY 11030, USA
4
Duke University Medical Center, 1821 Hillandale Rd, Suite 25A, Durham, NC 27705, USA
5
Boston University School of Medicine, Pulmonary Center, R304, Boston, MA 02118, USA
6
Levine Children’s Hospital, Atrium Health, 1000 Blythe Blvd, 32861, Charlotte, NC 2
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