Clementina Canessa1, Vera Gallo2, Claudio Pignata2, Antonino Trizzino3, Simona Graziani4, Baldassarre Martire5, Viviana Moschese4, Valentina Palladino6, Giorgio Maria Boggia7, Andrea Matucci8, Antonio Pecoraro9, Giuseppe Spadaro9, Alessandra Vultaggio8, Chiara Azzari1. 1. Department of Pediatric Immunology, Jeffrey Modell Center for Primary Immunodeficiency, Anna Meyer's Hospital, University of Florence, Florence, Italy. 2. Pediatric Section, Department of Translational Medical Science, Federico II University, Naples, Italy. 3. Department of Pediatric Hematology and Oncology, ARNAS Civico Di Cristina and Benfratelli Hospital, Palermo, Italy. 4. Department of Pediatrics, Policlinico Tor Vergata, Tor Vergata University, Rome, Italy. 5. Pediatric Oncology and Oncological Hematology, Bari University Hospital, Bari, Italy. 6. Department of Pediatrics, AOU "Policlinico-Giovanni XXIII", University of Bari "Aldo Moro", Bari, Italy. 7. Medical Affairs, CSL Behring, Milan, Italy. 8. Immunoallergology Unit, Department of Medical-Geriatric, AOU Careggi, Firenze, Italy. 9. Department of Translational Medical Sciences, Allergy and Clinical Immunology Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy.
Abstract
Background: Subcutaneous immunoglobulin G (SCIG) may be a better option than intravenous immunoglobulin G (IVIG) for patients with primary immunodeficiencies (PID) due to reduced systemic and serious adverse reactions and easier administration. The Infusione Bimensile di Immunoglobuline Sottocute (IBIS) study investigated the effects of Hizentra®, a 20%-concentrated SCIG, administered biweekly in patients with PID. This subanalysis aimed to evaluate clinical and laboratory outcomes in the IBIS pediatric subcohort. Methods: Thirteen children with PID were observed for 12 months retrospectively (with previous IVIG/SCIG) and prospectively with biweekly Hizentra. Results: Mean ± standard deviation serum IG levels during the retrospective (833.8 ± 175.7 mg/dL) and the prospective (842.0 ± 188.0 mg/dL) phases were comparable; there were also no differences in the number of infections. Conclusions: Biweekly Hizentra is a noninferior option with respect to previous IVIG/SCIG-based treatment.
Background: Subcutaneous immunoglobulin G (SCIG) may be a better option than intravenous immunoglobulin G (IVIG) for patients with primary immunodeficiencies (PID) due to reduced systemic and serious adverse reactions and easier administration. The Infusione Bimensile di Immunoglobuline Sottocute (IBIS) study investigated the effects of Hizentra®, a 20%-concentrated SCIG, administered biweekly in patients with PID. This subanalysis aimed to evaluate clinical and laboratory outcomes in the IBIS pediatric subcohort. Methods: Thirteen children with PID were observed for 12 months retrospectively (with previous IVIG/SCIG) and prospectively with biweekly Hizentra. Results: Mean ± standard deviation serum IG levels during the retrospective (833.8 ± 175.7 mg/dL) and the prospective (842.0 ± 188.0 mg/dL) phases were comparable; there were also no differences in the number of infections. Conclusions: Biweekly Hizentra is a noninferior option with respect to previous IVIG/SCIG-based treatment.
Authors: Ann Gardulf; Uwe Nicolay; Oscar Asensio; Ewa Bernatowska; Andreas Böck; Beatriz Costa Carvalho; Carl Granert; Stefan Haag; Dolores Hernández; Peter Kiessling; Jan Kus; Jaune Pons; Tim Niehues; Sigune Schmidt; Ilka Schulze; Michael Borte Journal: J Clin Immunol Date: 2006-04-26 Impact factor: 8.317
Authors: S Jolles; E Bernatowska; J de Gracia; M Borte; V Cristea; H H Peter; B H Belohradsky; V Wahn; J Neufang-Hüber; O Zenker; B Grimbacher Journal: Clin Immunol Date: 2011-06-12 Impact factor: 3.969
Authors: R Gustafson; A Gardulf; S Hansen; H Leibl; W Engl; M Lindén; A Müller; L Hammarström Journal: Clin Exp Immunol Date: 2008-03-12 Impact factor: 4.330
Authors: 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 Di Gioacchino; Alessia Gatta; Andrea Finocchi; Francesco Licciardi; Silvana Martino; Marco De Carli; Viviana Moschese; Chiara Azzari Journal: Int J Immunopathol Pharmacol Date: 2016-12-07 Impact factor: 3.219