Factor VIII products and inhibitor development in previously treated patients with severe or moderately severe hemophilia A: a systematic review

• Published in: Journal of thrombosis and haemostasis 2018-06, Vol.16 (6), p.1055-1068
• Main Authors: Hassan, S., Cannavò, A., Gouw, S. C., Rosendaal, F. R., van der Bom, J. G.
• Format: Article
• Language: English
• Subjects: Coagulation factors; Factor VIII deficiency; factor VIII; Hemophilia; hemophilia A; Immunogenicity; Meta-analysis; neutralizing antibodies; risk factors
• ISSN: 1538-7933; 1538-7836; 1538-7836
• DOI: 10.1111/jth.14124

Essentials Data on product‐related immunogenicity in previously treated haemophilia A patients is scarce. A systematic review and meta‐analysis of all currently available evidence was conducted. The overall incidence rate was 2.06 per 1000 person‐years (95% confidence interval: 1.06‐4.01). Some recombinant factor VIII products were associated with increased immunogenicity. Summary Background Patients with severe hemophilia A who have been treated extensively with factor VIII products have a low but potentially serious risk of inhibitor development. It is unknown why these patients develop inhibitors, and data on product‐related immunogenicity are scarce. Aims To summarize the currently available evidence on the relationship between inhibitor development and recombinant FVIII product type in previously treated patients (PTPs) with severe hemophilia A. Methods Longitudinal studies were included that reported on de novo inhibitor formation in patients with baseline FVIII activity levels of