Studies on the thrombogenicity of immunoglobulins manufactured in UNC-Hemoderivados: a comparative study

Santiago de Chile

Congreso; III Congreso LatinoamericanoLasid; 2013

LASID

Background: immnunoglobulins theraphy (Igs) is a modality approved in various conditions including immune deficiencies and autoimmune diseases. To date Igs has been considered as safe medications with minor side effects in both presentations for use intravenously (IVIG) or subcutaneously (SCIG). However, thromboembolic complications (TEC) are been recently well-documented and according to preliminary results the factor XI (FXI) and its activated form (FXIa) would be responsible for this property thrombogenic. Aim: to determine the levels of FXI and FXIa as well as the presence of activated coagulation factors in several batches of Igs preparations manufactured in UNC-Hemoderivados during the period 2011-2013 and b) to compare the results obtained with other commercial preparations.Materials and methods: factor XI was determined by coagulometric assay using deficient plasma of FXI on ACL 7000 and FXIa by chromogenic substrate using a commercial kit (Hyphen, France). Activated coagulation factors were assayed using the no-activated partial thromboplastin time (NAPTT) according to Ph European. Different batches of Igs were analyzed, IVIG=11 and SCIG=9 which were manufactured in UNC-Hemoderivados and two commercial preparations were analyzed. Results: FXI levels were < 0.1 in both IVIG and SCIG presentations of UNC-Hemoderivados and < 0.1 UI/ml and 0.95 UI/ml for commercial preparations, respectively. FXIa levels were 1.81 and 0.0013 ng/ml and 7.86 and 0.025 ng/ml for SCIG and IVIG manufactured in UNC-Hemoderivados compared to commercial products, respectively. Any significant differences were noted in the NAPTT obtained in IVIG and SCIV for the products manufactured in UNC-Hemoderivados and commercial preparations. Conclusion: All the batches of Igs showed values of FXI and FXIa lower than other available commercial with a significative difference, p< 0.001 and p< 0.001, respectively. These results more the absence of activated coagulation factors estimated by NAPTT suggests that both preparations og Igs would not be potentially thrombogenic.