Michael A Tortorici1, John-Philip Lawo2, Rudolf Weide3, Jeanine Jochems4, Shilpa Puli5, Jutta Hofmann6, Dietmar Pfruender7, Mikhail A Rojavin8. 1. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA. Electronic address: Michael.Tortorici@cslbehring.com. 2. CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany. Electronic address: John-Philip.Lawo@cslbehring.com. 3. Institute for Health Care Research in Oncology and Outpatient Clinic for Hematology and Oncology, Neversstraße 5, 56068 Koblenz, Germany. Electronic address: weide@onkologie-koblenz.de. 4. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA. Electronic address: Jeanine.Jochems@cslbehring.com. 5. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA. 6. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA. Electronic address: Jutta.Hofmann@cslbehring.com. 7. CSL Behring GmbH, Philipp-Reis-Strasse 2, 65795 Hattersheim, Germany. Electronic address: Dietmar.Pfruender@cslbehring.com. 8. CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA. Electronic address: Mikhail.Rojavin@cslbehring.com.
Abstract
PURPOSE: Primary (PID) and secondary immune deficiencies (SID) represent diverse groups of diagnoses, yet both can be effectively treated with intravenous immunoglobulin (IVIG) replacement therapy. Guidelines for the use of IVIG in SID vary due to the paucity of data. The objective was to analyze available IVIG Privigen® (IgPro10, CSL Behring, Bern, Switzerland) data on Efficiency Index (EI) and pharmacokinetic (PK) parameters in patients with PID and SID. METHODS: Three Privigen® studies (NCT00168025, NCT00322556, and the observational study IgPro10_5001) were used to identify patients with PID and SID meeting the qualifying criteria for the PK analysis. PK properties of IVIG were estimated using a population PK model based on a standard two-compartment PK model. Immunoglobulin G (IgG) EI was calculated as the gain in serum IgG level per unit external IgG dose. RESULTS: A similar IVIG dose-serum IgG concentration relationship was observed in patients with PID (N = 90) and SID (N = 91). IgG EI was inversely proportional to the endogenous IgG concentration and comparable in PID (slope = -1.079) and SID (slope = -2.12). CONCLUSIONS: These findings indicate that the disposition of Privigen® is similar during IgG replacement therapy in PID and SID. The results contribute to the understanding of IVIG treatment of SID and may support an evidence-based approach for the use of IVIG in SID in the future.
PURPOSE: Primary (PID) and secondary immune deficiencies (SID) represent diverse groups of diagnoses, yet both can be effectively treated with intravenous immunoglobulin (IVIG) replacement therapy. Guidelines for the use of IVIG in SID vary due to the paucity of data. The objective was to analyze available IVIG Privigen® (IgPro10, CSL Behring, Bern, Switzerland) data on Efficiency Index (EI) and pharmacokinetic (PK) parameters in patients with PID and SID. METHODS: Three Privigen® studies (NCT00168025, NCT00322556, and the observational study IgPro10_5001) were used to identify patients with PID and SID meeting the qualifying criteria for the PK analysis. PK properties of IVIG were estimated using a population PK model based on a standard two-compartment PK model. Immunoglobulin G (IgG) EI was calculated as the gain in serum IgG level per unit external IgG dose. RESULTS: A similar IVIG dose-serum IgG concentration relationship was observed in patients with PID (N = 90) and SID (N = 91). IgG EI was inversely proportional to the endogenous IgG concentration and comparable in PID (slope = -1.079) and SID (slope = -2.12). CONCLUSIONS: These findings indicate that the disposition of Privigen® is similar during IgG replacement therapy in PID and SID. The results contribute to the understanding of IVIG treatment of SID and may support an evidence-based approach for the use of IVIG in SID in the future.
Authors: Josep Gamez; María Salvadó; Francesc Carmona; Miriam de Nadal; Laura Romero; Daniel Ruiz; Alberto Jáuregui; Olga Martínez; Javier Pérez; Pilar Suñé; María Deu Journal: Ther Adv Neurol Disord Date: 2019-07-17 Impact factor: 6.570