Efficacy and safety of Privigen^®, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura

Authors: Robak, T.¹; Salama, A.²; Kovaleva, L.³; Vyhovska, Y.⁴; Davies, S. V.⁵; Mazzucconi, M. G.⁶; Zenker, O.⁷; Kiessling, P.⁷; The International Privigen® in ITP Study Group

Source: Hematology, Volume 14, Number 4, August 2009 , pp. 227-236(10)

Publisher: Maney Publishing

Buy & download fulltext article:

Price: $48.00 plus tax (Refund Policy)

Abstract:

Intravenous immunoglobulin (IVIG) has become a mainstay of treatment for acute and chronic immune thrombocytopenic purpura (ITP). The efficacy and safety of Privigen^®, a new, ready-to-use, 10% liquid human IgG formulation, was evaluated in this open-label, multicentre study. Privigen^® infusions (1 g/kg per day for 2 consecutive days, days 1 and 2) were given to 57 adolescent and adult patients with chronic ITP and platelet counts ?20 × 10⁹/l. By day 7, 80.7% of patients (95% CI, 69·2, 89·3) achieved platelet counts of ?50 × 10⁹/l. Correspondingly, haemorrhage number and severity were significantly reduced. Adverse events were generally mild or moderate and typical of underlying disease and IVIG treatment. Privigen^® was well tolerated – 104 of 114 infusions were performed at the maximum permitted infusion rate (4 mg/kg/min). Thus, in patients with chronic ITP, a two-day regimen of Privigen^® was effective in increasing platelet count, reducing bleeding events and was well tolerated.

Keywords: LIQUID INTRAVENOUS IMMUNOGLOBULIN; SAFETY; CHRONIC IMMUNE THROMBOCYTOPENIC PURPURA; EFFICACY

Document Type: Research Article

DOI: http://dx.doi.org/10.1179/102453309X439773

Affiliations: 1: Department of Hematology, Medical University of Lodz, Lodz, Poland 2: Institut für Transfusionsmedizin, Charité-Universitätsmedizin Berlin, Berlin, Germany 3: Russian Academy of Medical Sciences, Moscow, Russia 4: Institute of Blood Pathology & Transfusion Medicine AMS, Lviv, Ukraine 5: Taunton & Somerset Hospital, Musgrove Park, Taunton, Somerset, UK 6: Dipartimento di Biotecnologie Cellulari ed Ematologia, 'Sapienza' University of Rome, Rome, Italy 7: CSL Behring GmbH, Marburg, Germany