No induction of antibodies in patients treated with the recombinant plasminogen activator reteplase (BM 06.022)

• Published in: Fibrinolysis & proteolysis 1997-09, Vol.11 (5), p.259-264
• Main Authors: Kientsch-Engel, R., Böhm, E., Neubert, P., Martin, U., Fischer, S., Smolarz, A.
• Format: Article
• Language: English
• ISSN: 1369-0191; 1532-222X
• DOI: 10.1016/S0268-9499(97)80110-5

Any new substance produced by recombinant DNA techniques for therapeutic use must be tested for its immunogenic properties. The purpose of this study was to investigate whether the administration of i.v. double bolus of reteplase in patients with acute myocardial infarction leads to formation of specific antibodies. During the clinical development of reteplase 2640 plasma samples were tested, post dose between day 10 and 1 year, within 5 controlled clinical studies performed in Europe and the USA. Antibody titres were measured using an internally developed enzyme-linked immunoabsorbent assay (ELISA). If the absorbance test exceeded a specific upper limit (cut-off value), a competitive inhibition test was conducted. All patients tested who received reteplase were found to be negative for reteplase specific antibodies. The confirmation of absence of antibodies is consistent with the low rate of allergic reactions in controlled clinical trials with reteplase. Retreatment with reteplase is also expected to be free of the immunologic risks known to occur after administration of streptokinase or streptokinase-like thrombolytics.