Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.

Autor: Wasserman RL; Allergy Partners of North Texas Research, 7777 Forest Lane, Suite B-332, Dallas, TX 75230, USA., Cunningham-Rundles C; Division of Clinical Immunology, Department of Medicine, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY 10029, USA.; Department of Pediatrics, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY 10029, USA., Anderson J; Clinical Research Center of Alabama (a division of AllerVie Health), 504 Brookwood Blvd Suite 250, Birmingham, AL 35209, USA., Lugar P; Departments of Medicine & Pediatrics, Division of Pulmonary, Allergy & Critical Medicine; Duke University Medical Center, Durham, NC 27705, USA., Palumbo M; Allergy & Clinical Immunology Associates, 180 Fort Couch Road, Pittsburgh PA 15241, USA., Patel NC; Children's Healthcare of Atlanta, Division of Pulmonary, Allergy/Immunology, Cystic Fibrosis, & Sleep, Emory University School of Medicine, 1400 Tullie RD NE, Atlanta, GA 30329, USA., Hofmann J; CSL Behring AG, Wankdorfstrasse 10, 3014, Bern, Switzerland., Glassman F; CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA., Rogers E; Enable Injections, Inc., 2863 E. Sharon Rd Cincinnati, OH 45241, USA., Praus M; CSL Behring Innovation GmbH, Emil-von-Behring-Straße 76, 35041, Marburg, Germany., Rojavin MA; CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA.
Jazyk: angličtina
Zdroj: Immunotherapy [Immunotherapy] 2022 Nov; Vol. 14 (16), pp. 1315-1328. Date of Electronic Publication: 2022 Sep 21.
DOI: 10.2217/imt-2022-0097
Abstrakt: Aim: A novel, Investigational Wearable Infusor (IWI) was evaluated in a randomized, controlled, crossover, open-label study to determine if its delivery of subcutaneous immunoglobulin (IgPro20) achieved a comparable area under the concentration-time curve (AUC) for immunoglobulin G (IgG) versus the Crono S-PID-50 infusion pump (CP). EudraCT: 2016-003798-16. Materials & methods: Patients with primary immunodeficiency (PID) were randomized to receive IgPro20 in Sequence 1 (CP/IWI) or 2 (IWI/CP). The primary end point was AUC for IgG during the final week of each 4-week period. Results: 23 patients were enrolled. Evaluation of area under the concentration-time curve from time 0 (pre-infusion) to 7 days after infusion (AUC 0-7 days ) (IWI: 1806 h*g/l; CP: 1829 h*g/l) and geometric mean ratio indicated comparable AUCs for IgG for both devices. Conclusion: Similar IgG exposure, indicated by AUC values, can be achieved with IgPro20 using the IWI or CP in PID.
Databáze: MEDLINE
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