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Meta-analysis of Inhibitor Formation in Patients with Hemophilia A
Treated with Sucrose-formulated Recombinant Factor VIII
Monika Maas-Enriquez,1 Eduard Gorina,2 Naghmana Bajwa,2 Georg Lemm2
1Bayer HealthCare, Leverkusen, Germany; 2Bayer HealthCare, Berkeley, California, USA
Background
Sucrose-formulated recombinant FVIII (rFVIII-FS; Kogenate® Bayer [Kogenate® FS]), which was approved in 2000,
is indicated in the treatment of patients with classical hemophilia (hemophilia A).
Multicenter, international clinical trials in patients with severe (<2% FVIII) hemophilia A have demonstrated the
safety and efficacy of rFVIII-FS for the treatment of bleeds in adult and pediatric populations.1,2
Clinical trials of rFVIII-FS demonstrated no evidence of de novo inhibitor formation in previously treated patients
(PTPs; n = 71);1 the incidence was 15% (9/60) in a study of PUPs and minimally treated patients (MTPs), who are
generally at highest risk for inhibitor development.2
Because the inhibitor incidence published to date is based on a small number of patients,1,2 an updated cumulative
review of inhibitor data collected from phase I-IV Bayer-sponsored clinical trials, postmarketing surveillance (PMS)
studies, investigator-sponsored clinical trials (ISTs), and spontaneous field reports, including literature reports,
was conducted.
原文下载：Kogenate _FS治疗血友病A时FⅧ抑制物发生率的Meta分析
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