title: Rapid infusions of human normal immunoglobulin 50g/l are safe and well tolerated in immunodeficiencies and immune thrombocytopenia.
abstract: Intravenous immunoglobulin (IVIg) is accepted as an effective and well-tolerated treatment for primary and secondary immunodeficiencies (ID) and immune thrombocytopenia (ITP). Adverse reactions of IVIg are usually mild, comprising transient flu-like symptoms, change in blood pressure and tachycardia. However IVIg therapy can be burdensome for both patients and healthcare facilities, since the infusion may take up to 4h to administer. The objective of our multicentre, prospective, open-label phase III trial was to evaluate the tolerability and safety of human normal immunoglobulin 50g/l (Ig VENA) at high intravenous infusion rates in adult patients with ID and ITP who had previously tolerated IVIg treatment, by progressively increasing infusion rate up to 8ml/kg/hr. 39 ID patients received three infusions, 5 ITP patients received up to a maximum of 5 infusions for a maximum of 5days. Overall 55 adverse events were reported in 18 patients, and all were mild and self-limiting. Two serious adverse events occurred in ID patients and 1 in an ITP patient; none was fatal or treatment-related. No clinically significant changes or abnormalities were observed in vital signs, laboratory results and HRQoL. In summary, in this study, more rapid IVIg infusions were well tolerated by ID and ITP patients, while maintaining their quality of life, helping to minimise the time spent in outpatient hospital visiting to potentially optimise adherence to treatment.
authors.affiliation: Department of Translational Medical Sciences, Center for Basic and Clinical Immunology Research, University of Naples Federico II, Napoli, Italy. Electronic address: spadaro@unina.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Spadaro
authors.affiliation: AOU Careggi, SOD Immunoallergologia, Firenze, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Vultaggio
authors.affiliation: AOU Careggi, SOD Ematologia, Firenze, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Alberto Bosi
authors.affiliation: Onkologie, Westerstede, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Reichert
authors.affiliation: Onkologische Praxis, Aurich, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Janssen
authors.affiliation: Department of Translational Medical Sciences, Center for Basic and Clinical Immunology Research, University of Naples Federico II, Napoli, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Lamacchia
authors.affiliation: Department of Translational Medical Sciences, Center for Basic and Clinical Immunology Research, University of Naples Federico II, Napoli, Italy.
authors.forename: Liliana
authors.initials: L
authors.lastname: Nappi
authors.affiliation: Department of Translational Medical Sciences, Center for Basic and Clinical Immunology Research, University of Naples Federico II, Napoli, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pecoraro
authors.affiliation: Department of Molecular Medicine, "Sapienza" University of Rome, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Milito
authors.affiliation: AOU Careggi, SOD Immunoallergologia, Firenze, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ferraro
authors.affiliation: AOU Careggi, SOD Immunoallergologia, Firenze, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Matucci
authors.affiliation: AOU Careggi, SOD Ematologia, Firenze, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bacchiarri
authors.affiliation: AOU Careggi, SOD Ematologia, Firenze, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Carrai
authors.affiliation: Onkologie, Westerstede, Germany.
authors.forename: Azra
authors.initials: A
authors.lastname: Hibbeler
authors.affiliation: Onkologische Praxis, Aurich, Germany.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Speckman
authors.affiliation: Clinical Development & Operations, Kedrion S.p.A., Castelvecchio Pascoli (Lucca), Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Guarnieri
authors.affiliation: Clinical Development & Operations, Kedrion S.p.A., Castelvecchio Pascoli (Lucca), Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Bongiovanni
authors.affiliation: Department of Molecular Medicine, "Sapienza" University of Rome, Italy.
authors.forename: Isabella
authors.initials: I
authors.lastname: Quinti
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000276:immunology / Q000628:therapy*; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000276:immunology / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016756:Immunoglobulins, Intravenous
keywords: Cost effectiveness; Intravenous immunoglobulin; Quality of life; Rapid infusion