PB1255 - Comparison of Coagulation Factor VIII Biosimilars (Kogenate FS Vs NovoEight) in Altering Prothrombin Time, activated Partial Thromboplastin Time, and levels of Factors VII and VIII in Hemophilia A

Tuesday, June 25, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

Kannan Meganathan, PhD

Assistant Professor
Central University of Tamil Nadu
Thiruvarur, Tamil Nadu, India

Co-Author(s)

CR

Chitrali Laha Roy

Research Scholar
Central University of Tamil Nadu
Thiruvarur, Tamil Nadu, India
FS

Fakiha Siddiqui, BDS

PhD Candidate, Research Associate
Universidad Católica San Antonio de Murcia, Loyola University Chicago
Maywood, Illinois, United States
MI

Massimo Iacobelli

Researcher
Loyola University Chicago
Chicago, Illinois, United States
Ravi Ranjan, MSc PhD

Scientist
All India Institute of Medical Sciences
New Delhi, Delhi, India
SB

Sujit Kumar Behera

Assistant Professor
Central University of Tamil Nadu
Thiruvarur, Tamil Nadu, India
NG

Natarajan Gopalan

Professor
Central University of Tamil Nadu
Thiruvarur, Tamil Nadu, India
MM

Manoranjan Mahapatra

Professor and Head
All India institute of Medical Sciences, New Delhi
New Delhi, Delhi, India
RS

Renu Saxena

Professor
All India Institute of Medical Sciences
New Delhi, Delhi, India
JF

Jawed Fareed

Professor
Loyola University Chicago
Chicago, Illinois, United States

Background: Hemophilia A (HA), is an X-linked, hemorrhagic disorder resulting from a congenital deficit of factor VIII (FVIII). In hemophilia, activated partial thromboplastin time (aPTT) is usually elevated and prothrombin time (PT) remain within normal ranges. Although FVIII deficiency is crucial for establishing the diagnosis of HA, levels of factor VII (FVII) are also impacted. Several studies are comparing different recombinant biosimilars of concentrated FVIII in hemophilia patients, but none of them analyzed or compared their effect on PT, aPTT, and levels of FVII and FVIII. This study aims to compare the effects of biosimilars of recombinant FVIII, namely Kognate FS and NovoEight, in HA on PT, aPTT, FVII, and FVIII values.

Aims: To compare the effects of biosimilars of recombinant FVIII, namely Kognate FS and NovoEight, in patients with hemophilia A on PT, aPTT, FVII, and FVIII values.

Methods: A mixing study was carried out on 30 severe HA patients to check for correction of PT, aPTT, FVIII, and FVII by two different drugs, namely Kogenate FS and NovoEight. The samples were tested on a fully automated coagulation analyzer, Ceveron alpha for PT, aPTT, FVIII, and FVII before and after adding the drug solutions (Table 1).

Results: In a comparison of both of the investigational drugs to the original values of PT, aPTT and FVIII, among-group comparison with post-hoc pairwise comparisons showed a high statistically significant difference for aPTT and FVIII, compared to pre-treatment values (Table 1). A negative correlation was observed between PT and FVII values after adding Kogenate FS (r=-0.103, p< 0.001), aPTT and FVIII values after adding Kogenate FS (r=-0.898, p< 0.001), aPTT and FVIII values after adding NovoEight (r=-0.865, p< 0.001).

Conclusion(s): These investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII. Both the investigated drugs show a high potential for altering aPTT, FVIII and FVII.