Comparative study of clinical efficacy of biosimilar Nektelisa (tenecteplase) based on randomized clinical trial

Aim. To present the results of a comparative study of the efficacy and safety of the Russian biosimilar Nektelisa (AO GENERIUM, Russia) and the reference biological drug Metalyse (Boehringer Ingelheim Pharma, GmbH & Co. KG, Germany) when used in patients with ST-segment elevation myocardial infarction (STEMI).

Material and methods. The study included 244 male (n=204) and female (n=41) patients aged 36 to 75 years with STEMI. The study was conducted in 14 clinical centers of the Russian Federation and 2 centers in Belarus. Patients were randomized into two groups 1:1 as follows: 122 patients received the domestic biosimilar Nektelisa, and 122 patients received the reference drug Metalyse. The main criterion of efficacy is the myocardial reperfusion rate (TIMI grade 3 coronary flow). Safety assessment included analysis of adverse reactions, hemorrhagic complications of thrombolytic therapy, and immunogenicity.

Results. The incidence of myocardial reperfusion (TIMI grade 3) was 53,7% in the Nektelisa group and 57,1% in the Metalyse group, confirming therapeutic equivalence of the drugs (difference -3,4%, 95% confidence interval: -16,0% to 9,1%). The safety profile of Nektelisa was comparable to that of Metalyse, with fewer adverse events recorded in the Nektelisa group (7,4% in Nektelisa group vs 15,7% in the Metalyse group). Most of the recorded adverse reactions were hemorrhagic complications of thrombolytic therapy (bleeding of varying severity and locations). During the study, 13 bleeding episodes were noted in 8 patients in the Nektelisa group and 30 bleeding episodes in 16 patients in the Metalyse group. The incidence of major bleeding in the Nektelisa and Metalyse groups according to TIMI classification was 0,8% and 2,5%, while according to the ISTH classification — 0,8% and 3,3%, respectively. In addition, BARC type 5b bleeding was revealed in 0% and 10%, respectively. The incidence of hemorrhagic strokes was 1,2%, all of which were registered in the Metalyse group.

Conclusion. The clinical trial proved that Nektelisa (AO GENERIUM, Russia) is a biological analogue of Metalyse (Boehringer Ingelheim Pharma, GmbH & Co. KG, Germany).

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