Comparative Efficacy of Recombinant FVIII and Recombinant FVII Biosimilars in Severe Hemophilia A.

IF 2.3 4区医学 Q2 HEMATOLOGY

Clinical and Applied Thrombosis/Hemostasis Pub Date : 2025-01-01 Epub Date: 2025-03-21 DOI:10.1177/10760296251329329

Meganathan Kannan, Chitrali Laha Roy, Prakasha Kempaiah, Ravi Ranjan, Manoranjan Mahapatra, Renu Saxena, Jawed Fareed

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Abstract

BackgroundHemophilia A (HA) occurs due to the deficiency of factor VIII (FVIII). Individuals with HA generally present with elevated activated partial thromboplastin time (aPTT) and normal prothrombin time (PT). The only possible treatment for this bleeding condition is factor concentrate.AimThe aim of this study is to compare the effect of recombinant factor VIII (rFVIII) and recombinant factor VII (rFVII) on prothrombin time (PT), activated partial thromboplastin time (aPTT), FVIII and FVII in severe HA.MethodologyA mixing study was conducted on 30 samples of severe HA patients to assess the correction of PT, aPTT, FVIII, and FVII values using biosimilars of rFVIII (NovoEight and Kogenate FS) and rFVII (NovoSeven and AryoSeven) using a fully automated coagulation analyser 'Ceveron alpha'.ResultsAll the four drugs demonstrated a significant alteration for both PT (P < .0001) and aPTT (P < .0001) values. A significant, notable increase of FVIII levels were observed for FVIII biosimilars. Further investigation into the effect of rFVII biosimilars on inhibitor-positive patients revealed a significant alteration in PT (P < .0001) and aPTT (P < .001) values.ConclusionTo the best of our knowledge, this is the first study to compare the effect of all four drugs on PT, aPTT, FVIII, and FVII. Two different groups of biosimilars were found to have a high potential to alter the PT and aPTT values. The FVIII biosimilars are efficient in increasing the FVIII levels.

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重组FVIII与重组FVII生物仿制药治疗严重血友病A的疗效比较。

血友病A （HA）的发生是由于缺乏因子VIII （FVIII）。HA患者通常表现为活化的部分凝血活素时间（aPTT）升高和凝血酶原时间（PT）正常。这种出血状况唯一可能的治疗方法是浓缩因子。目的比较重组因子VIII （rFVIII）和重组因子VII （rFVII）对严重HA患者凝血酶原时间（PT）、活化部分凝血活素时间（aPTT）、FVIII和FVII的影响。方法采用全自动凝血分析仪“everon alpha”对30例严重HA患者样本进行混合研究，评估rFVIII （NovoEight和Kogenate FS）和rFVII （NovoSeven和AryoSeven）的生物仿制药对PT、aPTT、FVIII和FVII值的校正。结果四种药物均能显著改变PT （P， P， P， P）的水平

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来源期刊

Clinical and Applied Thrombosis/Hemostasis 医学-外周血管病

CiteScore

4.40

自引率

3.40%

发文量

150

审稿时长

2 months

期刊介绍： CATH is a peer-reviewed bi-monthly journal that addresses the practical clinical and laboratory issues involved in managing bleeding and clotting disorders, especially those related to thrombosis, hemostasis, and vascular disorders. CATH covers clinical trials, studies on etiology, pathophysiology, diagnosis and treatment of thrombohemorrhagic disorders.