Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies

Clementina Canessa, Jessica Iacopelli, Antonio Pecoraro, Giuseppe Spadaro, Andrea Matucci, Cinzia Milito, Alessandra Vultaggio, Carlo Agostini, Francesco Cinetto, Maria Giovanna Danieli, Simona Gambini, Carolina Marasco, Antonino Trizzino, Angelo Vacca, Domenico De Mattia, Baldassarre Martire, Alessandro Plebani, Mario Gioacchino, Alessia Gatta, Andrea Finocchi & 5 others Francesco Licciardi, Silvana Martino, Marco De Carli, Viviana Moschese, Chiara Azzari

Research output: Contribution to journalArticle

Abstract

In patients with primary antibody deficiencies, subcutaneous administration of IgG (SCIG) replacement is effective, safe, well-tolerated, and can be self-administered at home. A new SCIG replacement at 20% concentration (Hizentra(®)) has been developed and has replaced Vivaglobin(®) (SCIG 16%). An observational prospective multi-centric open-label study, with retrospective comparison was conducted in 15 Italian centers, in order to investigate whether and to what extent switching to Hizentra(®) would affect frequency of infusions, number of infusion sites, patients' satisfaction, and tolerability in patients previously treated with Vivaglobin(®) or intravenous immunoglobulins (IVIG). Any variations of dosage, frequency and duration of the infusions, and of number of infusion sites induced by Hizentra(®) with respect to the former treatment were recorded. Practical advantages and disadvantages of Hizentra(®), with respect to the medicinal product formerly used, and the variations in patients' therapy-related satisfaction were monitored by means of the TSQM (Treatment Satisfaction Questionnaire for Medication); number, frequency, and duration of infectious events and adverse effects were recorded. Eighty-two patients switched to Hizentra(®): 19 (23.2%) from IVIG and 63 (76.8%) from Vivaglobin(®). The mean interval between infusions was not affected by the shift (7.0 ± 2.0 days with previous treatment versus 7.1 ± 1.2 during Hizentra(®)). A decrease in the number of infusion sites with Hizentra(®) was recorded in 12 out of 56 patients for whom these data were available. At 6 months, 89.7% of patients were satisfied with Hizentra(®); no difference in terms of effectiveness, side effects, convenience, and global satisfaction was observed. No difference in the incidence of adverse events was reported.

Original languageEnglish
Pages (from-to)73-82
Number of pages10
JournalInternational Journal of Immunopathology and Pharmacology
Volume30
Issue number1
DOIs
Publication statusPublished - Dec 7 2016

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Immunoglobulins
Antibodies
Immunoglobulin G
Intravenous Immunoglobulins
Therapeutics
Hizentra
Patient Satisfaction
Retrospective Studies
Incidence
Vivaglobin

Keywords

  • Journal Article

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Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies. / Canessa, Clementina; Iacopelli, Jessica; Pecoraro, Antonio; Spadaro, Giuseppe; Matucci, Andrea; Milito, Cinzia; Vultaggio, Alessandra; Agostini, Carlo; Cinetto, Francesco; Danieli, Maria Giovanna; Gambini, Simona; Marasco, Carolina; Trizzino, Antonino; Vacca, Angelo; De Mattia, Domenico; Martire, Baldassarre; Plebani, Alessandro; Gioacchino, Mario; Gatta, Alessia; Finocchi, Andrea; Licciardi, Francesco; Martino, Silvana; De Carli, Marco; Moschese, Viviana; Azzari, Chiara.

In: International Journal of Immunopathology and Pharmacology, Vol. 30, No. 1, 07.12.2016, p. 73-82.

Research output: Contribution to journalArticle

Canessa, C, Iacopelli, J, Pecoraro, A, Spadaro, G, Matucci, A, Milito, C, Vultaggio, A, Agostini, C, Cinetto, F, Danieli, MG, Gambini, S, Marasco, C, Trizzino, A, Vacca, A, De Mattia, D, Martire, B, Plebani, A, Gioacchino, M, Gatta, A, Finocchi, A, Licciardi, F, Martino, S, De Carli, M, Moschese, V & Azzari, C 2016, 'Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies', International Journal of Immunopathology and Pharmacology, vol. 30, no. 1, pp. 73-82. https://doi.org/10.1177/0394632016681577
Canessa, Clementina ; Iacopelli, Jessica ; Pecoraro, Antonio ; Spadaro, Giuseppe ; Matucci, Andrea ; Milito, Cinzia ; Vultaggio, Alessandra ; Agostini, Carlo ; Cinetto, Francesco ; Danieli, Maria Giovanna ; Gambini, Simona ; Marasco, Carolina ; Trizzino, Antonino ; Vacca, Angelo ; De Mattia, Domenico ; Martire, Baldassarre ; Plebani, Alessandro ; Gioacchino, Mario ; Gatta, Alessia ; Finocchi, Andrea ; Licciardi, Francesco ; Martino, Silvana ; De Carli, Marco ; Moschese, Viviana ; Azzari, Chiara. / Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies. In: International Journal of Immunopathology and Pharmacology. 2016 ; Vol. 30, No. 1. pp. 73-82.
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AU - Canessa, Clementina

AU - Iacopelli, Jessica

AU - Pecoraro, Antonio

AU - Spadaro, Giuseppe

AU - Matucci, Andrea

AU - Milito, Cinzia

AU - Vultaggio, Alessandra

AU - Agostini, Carlo

AU - Cinetto, Francesco

AU - Danieli, Maria Giovanna

AU - Gambini, Simona

AU - Marasco, Carolina

AU - Trizzino, Antonino

AU - Vacca, Angelo

AU - De Mattia, Domenico

AU - Martire, Baldassarre

AU - Plebani, Alessandro

AU - Gioacchino, Mario

AU - Gatta, Alessia

AU - Finocchi, Andrea

AU - Licciardi, Francesco

AU - Martino, Silvana

AU - De Carli, Marco

AU - Moschese, Viviana

AU - Azzari, Chiara

PY - 2016/12/7

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N2 - In patients with primary antibody deficiencies, subcutaneous administration of IgG (SCIG) replacement is effective, safe, well-tolerated, and can be self-administered at home. A new SCIG replacement at 20% concentration (Hizentra(®)) has been developed and has replaced Vivaglobin(®) (SCIG 16%). An observational prospective multi-centric open-label study, with retrospective comparison was conducted in 15 Italian centers, in order to investigate whether and to what extent switching to Hizentra(®) would affect frequency of infusions, number of infusion sites, patients' satisfaction, and tolerability in patients previously treated with Vivaglobin(®) or intravenous immunoglobulins (IVIG). Any variations of dosage, frequency and duration of the infusions, and of number of infusion sites induced by Hizentra(®) with respect to the former treatment were recorded. Practical advantages and disadvantages of Hizentra(®), with respect to the medicinal product formerly used, and the variations in patients' therapy-related satisfaction were monitored by means of the TSQM (Treatment Satisfaction Questionnaire for Medication); number, frequency, and duration of infectious events and adverse effects were recorded. Eighty-two patients switched to Hizentra(®): 19 (23.2%) from IVIG and 63 (76.8%) from Vivaglobin(®). The mean interval between infusions was not affected by the shift (7.0 ± 2.0 days with previous treatment versus 7.1 ± 1.2 during Hizentra(®)). A decrease in the number of infusion sites with Hizentra(®) was recorded in 12 out of 56 patients for whom these data were available. At 6 months, 89.7% of patients were satisfied with Hizentra(®); no difference in terms of effectiveness, side effects, convenience, and global satisfaction was observed. No difference in the incidence of adverse events was reported.

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DO - 10.1177/0394632016681577

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JO - International Journal of Immunopathology and Pharmacology

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