title: Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies.
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.
authors.affiliation: 1 Anna Meyer Children's Hospital, University of Florence, Florence, Italy.
authors.forename: Clementina
authors.initials: C
authors.lastname: Canessa
authors.affiliation: 1 Anna Meyer Children's Hospital, University of Florence, Florence, Italy.
authors.forename: Jessica
authors.initials: J
authors.lastname: Iacopelli
authors.affiliation: 2 Department of Translational Medical Sciences, Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pecoraro
authors.affiliation: 2 Department of Translational Medical Sciences, Allergy and Clinical Immunology, University of Naples Federico II, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Spadaro
authors.affiliation: 3 SOD Immunoallergologia, AOU Careggi, Firenze, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Matucci
authors.affiliation: 4 Molecular Medicine Department, Sapienza University of Rome, Rome, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Milito
authors.affiliation: 3 SOD Immunoallergologia, AOU Careggi, Firenze, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Vultaggio
authors.affiliation: 5 Department of Medicine DIMED, Clinical Immunology, Padova University, Padova, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Agostini
authors.affiliation: 5 Department of Medicine DIMED, Clinical Immunology, Padova University, Padova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cinetto
authors.affiliation: 6 Clinical Medicine, "Ospedali Riuniti", Ancona, Italy.
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Danieli
authors.affiliation: 6 Clinical Medicine, "Ospedali Riuniti", Ancona, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Gambini
authors.affiliation: 7 Department of Biomedical Sciences and Human Oncology, Clinica Medica "G. Baccelli", University of Bari Medical School, Bari, Italy.
authors.forename: Carolina
authors.initials: C
authors.lastname: Marasco
authors.affiliation: 8 Department of Pediatric Hematology and Oncology, ARNAS Civico, Palermo, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Trizzino
authors.affiliation: 7 Department of Biomedical Sciences and Human Oncology, Clinica Medica "G. Baccelli", University of Bari Medical School, Bari, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Vacca
authors.affiliation: 9 Neonatology and NICU, Department of Biochemical Sciences and Human Oncology, University of Bari, Bari, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: De Mattia
authors.affiliation: 10 Department of Pediatric Science and Surgery, Pediatric Hospital "Policlinico-Giovanni XXIII", Bari, Italy.
authors.forename: Baldassarre
authors.initials: B
authors.lastname: Martire
authors.affiliation: 11 Department of Clinical and Experimental Sciences, Pediatrics Clinic and Institute for Molecular Medicine A. Nocivelli, University of Brescia, Spedali Civili di Brescia, Brescia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Plebani
authors.affiliation: 12 Department of Medicine and Science of Ageing, "G. d'Annunzio" University, Chieti, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Di Gioacchino
authors.affiliation: 12 Department of Medicine and Science of Ageing, "G. d'Annunzio" University, Chieti, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Gatta
authors.affiliation: 13 Department of Pediatrics, Unit of Immune and Infectious Diseases, Children's Hospital Bambino Gesù, Rome, Italy.|14 Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Finocchi
authors.affiliation: 15 SCDU Pediatria II, Immunoreumatologia, Città della Salute e della Scienza di Torino, Turin, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Licciardi
authors.affiliation: 15 SCDU Pediatria II, Immunoreumatologia, Città della Salute e della Scienza di Torino, Turin, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Martino
authors.affiliation: 16 Dipartimento di Medicina Interna, Azienda Ospedaliera Universitaria Santa Maria della Misericordia, Udine, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: De Carli
authors.affiliation: 17 Department of Pediatrics, "Tor Vergata" University, Policlinico "Tor Vergata", Rome, Italy.
authors.forename: Viviana
authors.initials: V
authors.lastname: Moschese
authors.affiliation: 1 Anna Meyer Children's Hospital, University of Florence, Florence, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Azzari
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D007136:Immunoglobulins / Q000008:administration & dosage / Q000627:therapeutic use; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000188:drug therapy*; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: C558471:Hizentra; D007074:Immunoglobulin G; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C510539:Vivaglobin
keywords: immunoglobulin replacement; intravenous immunoglobulins; primary immunodeficiency; subcutaneous immunoglobulins; therapy satisfaction