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

Publication ,  Journal Article
Wasserman, RL; Cunningham-Rundles, C; Anderson, J; Lugar, P; Palumbo, M; Patel, NC; Hofmann, J; Glassman, F; Rogers, E; Praus, M; Rojavin, MA
Published in: Immunotherapy
November 2022

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 (AUC0-7 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.

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Published In

Immunotherapy

DOI

EISSN

1750-7448

Publication Date

November 2022

Volume

14

Issue

16

Start / End Page

1315 / 1328

Location

England

Related Subject Headings

  • Wearable Electronic Devices
  • Infusion Pumps
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Immunoglobulin G
  • Humans
  • Cross-Over Studies
  • 3211 Oncology and carcinogenesis
  • 3204 Immunology
  • 1115 Pharmacology and Pharmaceutical Sciences
 

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Wasserman, R. L., Cunningham-Rundles, C., Anderson, J., Lugar, P., Palumbo, M., Patel, N. C., … Rojavin, M. A. (2022). Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump. Immunotherapy, 14(16), 1315–1328. https://doi.org/10.2217/imt-2022-0097
Wasserman, Richard L., Charlotte Cunningham-Rundles, John Anderson, Patricia Lugar, Michael Palumbo, Niraj C. Patel, Jutta Hofmann, et al. “Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.Immunotherapy 14, no. 16 (November 2022): 1315–28. https://doi.org/10.2217/imt-2022-0097.
Wasserman RL, Cunningham-Rundles C, Anderson J, Lugar P, Palumbo M, Patel NC, et al. Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump. Immunotherapy. 2022 Nov;14(16):1315–28.
Wasserman, Richard L., et al. “Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.Immunotherapy, vol. 14, no. 16, Nov. 2022, pp. 1315–28. Pubmed, doi:10.2217/imt-2022-0097.
Wasserman RL, Cunningham-Rundles C, Anderson J, Lugar P, Palumbo M, Patel NC, Hofmann J, Glassman F, Rogers E, Praus M, Rojavin MA. Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump. Immunotherapy. 2022 Nov;14(16):1315–1328.
Journal cover image

Published In

Immunotherapy

DOI

EISSN

1750-7448

Publication Date

November 2022

Volume

14

Issue

16

Start / End Page

1315 / 1328

Location

England

Related Subject Headings

  • Wearable Electronic Devices
  • Infusion Pumps
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Immunoglobulin G
  • Humans
  • Cross-Over Studies
  • 3211 Oncology and carcinogenesis
  • 3204 Immunology
  • 1115 Pharmacology and Pharmaceutical Sciences