Factor VIII Products and Inhibitor Development in Severe Hemophilia A

Abstract

Recombinant and plasma-derived factor VIII products conferred similar risks of inhibitor development, and the content of von Willebrand factor in the products and switching among products were not associated with the risk of inhibitor development. Second-generation full-length recombinant products were associated with an increased risk, as compared with third-generation products. (Funded by Bayer Healthcare and Baxter BioScience.).

Production of recombinant coagulation factors: Are humans the best host cells?

“…Some studies have shown that patients treated with second-generation rFVIII products presented a higher risk of inhibitor development when compared with third-generation products. [9][10][11] FVIII inhibitor is an immunoglobulin G (IgG) produced by patient that has high polyclonal affinity directed against the FVIII protein. 12 Inhibitory antibodies are directed usually against the A2, A3 and C2 FVIII domains.…”

Second‐generation recombinant factor VIII and inhibitor risk: interpretation of RODIN study findings and implications for patients with haemophilia A

“…It seems, we are experiencing a similar question following a recent report on differences in immunogenicity between various factor VIII (FVIII) concentrates in patients with haemophilia A [1]. The report provided incidences of the development of neutralizing antibodies (inhibitors) against FVIII -a severe side effect of the treatment with FVIII -according to product brands.…”

“…The RODIN report clearly describes all eligible patients and exclusions with the reasons for exclusion in Fig. 1, and very few data were missing [1]. In the Supplementary material [1] on missing data we read, 'In 12.4% of patients, the F8 gene mutation type was missing.…”

“…1, and very few data were missing [1]. In the Supplementary material [1] on missing data we read, 'In 12.4% of patients, the F8 gene mutation type was missing. These values were imputed by the prevalences of the F8 gene mutations in this study population.…”

“…After the commentary of Kessler and Iorio [1] on the results of RODIN [2], I read with interest the spicy rebuttal by van der Bom et al [3]. A few comments herewith.…”