Original article / research
Year : 2026 Month : July Volume : 15 Issue : 3 Page : PO01 - PO05 Full Version

Evaluation of Factor VIII Inhibitor Titre in Haemophilia A Patients: A Cross-sectional Study from a Tertiary Care Institute in Eastern India
Simanti Sinha, Ayandip Nandi
1. Consultant Pathologist, Department of Pathology, Vijaya Diagnostics Centre, Kolkata, West Bengal, India. 2. Associate Professor, Department of Pathology, Maharaja Jitendra Narayan Medical College, Coochbehar, Serampore, West Bengal, India.
 
Correspondence Address :
Dr. Ayandip Nandi,
48/7 Patuapara Lane, P.O. Serampore Dt. Hooghly-712201, Serampore,
West Bengal, India.
E-mail: ayandipnandi@gmail.com
 
ABSTRACT
: Introduction: Haemophilia has a high disease burden in India and development of inhibitors/antibodies to the Factor VIII (FVIII) replacement therapy is a major problem leading to treatment failure, poor quality of life and high financial burden. Identifying risk factors associated with inhibitor production may lead to prevention and plan future treatment approach modification.

Aim: To identify risk factors associated with development of inhibitors and correlation of inhibitor titres with symptom progression.

Materials and Methods: The present study was a institution-based cross-sectional study which was conducted on 52 previously diagnosed Haemophilia A patients, who were being treated with either FVIII, or Fresh Frozen Plasma (FFP) or both, in a tertiary care Institute in West Bengal from January 2012 to June 2013. Mixing study of activated Partial Thromboplastin Time (aPTT) was done. For those patients where mixing study showed presence of inhibitor/antibody, titre of inhibitor was calculated by Nimjegen modification of Bethesda assay. Titre was compared with parameters like age at first exposure, duration of therapy, type of product used etc. Statistical analysis was done using Statistical Package for the Social Sciences (SPSS) version 31.0 using Fisher’s exact test, odds ratio, confidence interval etc.,

Results: Patients with inhibitors in inherited Haemophilia A had an earlier age at diagnosis of Haemophilia A (<2 year) (OR=3.18, CI: 0.59-17.1) and also, an earlier age at first exposure to FVIII (<2 years) OR=26.0, 95% CI: 4.2-161.6; Fisher’s exact p-value <0.001. Patients receiving FVIII only as replacement therapy had a greater tendency to develop inhibitors(OR=26.0, 95% CI: 4.2-161.6); and within 60 days of exposure (OR=26.0; 95% CI: 7.3-924.6). Fisher’s-exact p-value <0.001; compared to combination of FVIII with FFP and cryoprecipitate. When compared between patients with High Titre Inhibitors (HTI) and Low Titre Inhibitors (LTI), HTI patients were found to have more severe bleeding episodes, lesser number of bleeding episodes, earlier age at first exposure to FVIII (OR=13.6), those who received FVIII only (OR=2.5) and fewer number of exposure days to FVIII (16.2 days for HTI compared to 30 days for LTI). The incidence of various transfusion transmitted infections in haemophiliacs was quite low (3.9%) with a comparatively higher incidence of Hepatitis C.

Conclusion: Chances of FVIII inhibitor increases with earlier age at diagnosis, earlier age of first exposure and patients receiving FVIII only. Inhibitors increase the risk of life-threatening bleeding episodes, and higher the titre, more were the chances of severe bleeding.
Keywords : Bethesda titre, Bleeding episodes, Clinicopathological correlation
DOI and Others : DOI: 10.7860/NJLM/2026/85321.2974 Date of Submission: Nov 11, 2025 Date of Peer Review: Jan 12, 2026 Date of Acceptance: Feb 24, 2026 Date of Publishing: Jul 01, 2026 AUTHOR DECLARATION: • Financial or Other Competing Interests: None • Was Ethics Committee Approval obtained for this study? Yes • Was informed consent obtained from the subjects involved in the study? Yes • For any images presented appropriate consent has been obtained from the subjects. NA PLAGIARISM CHECKING METHODS: • Plagiarism X-checker: Nov 11, 2025 • Manual Googling: Feb 18, 2026 • iThenticate Software: Feb 23, 2026 (3%) ETYMOLOGY: Author Origin EMENDATIONS: 7
 
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