Experimental Medicine and Biochemical Sciences, University of Perugia, Perugia, Italy.
Haemophilia. 2014 Mar;20(2):200-6. doi: 10.1111/hae.12283. Epub 2013 Oct 29.
The development of neutralizing antibodies to factor VIII (FVIII) is the most serious complication of therapy for haemophilia A. There is now excellent documentation that a large number of both genetic and environmental factors contribute to the risk of FVIII inhibitor incidence. One of the environmental factors that has been proposed as an influence on this complication is the occurrence of FVIII product switching. There are only a small number of clinical studies that have addressed this question, and thus, the amount of objective information available to assess this association is limited. In this review, in addition to summarizing past evidence pertinent to this subject, we present the results of a complementary strategy, a Delphi analysis, to add to the considerations of product switching and FVIII immunogenicity. With the imminent arrival in the clinic of several new FVIII products, the haemophilia community must be prepared to collect prospectively controlled data to better address this important management issue.
针对血友病 A 的治疗，产生针对凝血因子 VIII（FVIII）的中和抗体是最严重的并发症。现在有大量的证据表明，大量的遗传和环境因素都会导致出现 FVIII 抑制剂的风险。已经提出的环境因素之一是 FVIII 产品转换的发生。只有少数临床研究涉及到这个问题，因此，评估这种关联的客观信息有限。在这篇综述中，除了总结过去与这个主题相关的证据外，我们还介绍了一种补充策略的结果，即德尔菲分析，以增加对产品转换和 FVIII 免疫原性的考虑。随着几种新的 FVIII 产品即将在临床上应用，血友病社区必须准备好前瞻性地收集控制数据，以更好地解决这个重要的管理问题。
