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 language | English |
|---|---|
| Pages (from-to) | 73-82 |
| Number of pages | 10 |
| Journal | International Journal of Immunopathology and Pharmacology |
| Volume | 30 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Dec 7 2016 |
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- 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 journal › Article
}
TY - JOUR
T1 - Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies
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
Y1 - 2016/12/7
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.
AB - 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.
KW - Journal Article
U2 - 10.1177/0394632016681577
DO - 10.1177/0394632016681577
M3 - Article
VL - 30
SP - 73
EP - 82
JO - International Journal of Immunopathology and Pharmacology
JF - International Journal of Immunopathology and Pharmacology
SN - 0394-6320
IS - 1
ER -