Inhibitor development, safety and efficacy of Advate® among previously treated patients with hemophilia A in a postmarketing surveillance in Japan View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-01-02

AUTHORS

Katsuyuki Fukutake, Masashi Taki, Tadashi Matsushita, Keiji Nogami, Midori Shima, Akira Yoshioka, Junki Takamatsu, Haruhiko Uchikawa, Hiroshi Takagi, Morio Arai, Werner Engl, Akira Shirahata

ABSTRACT

Rurioctocog alfa (recombinant factor VIII: Advate®) is available for the control of bleeding in patients with hemophilia A in Japan. To evaluate the inhibitor development, safety, and efficacy of rurioctocog alfa, a non-interventional and observational postmarketing surveillance was conducted on 352 previously treated Japanese patients aged 1–76 years with ≥ 4 exposure days under the conditions of routine clinical practice. A post-hoc comparison of the mean annualized bleeding rates which required treatment with rurioctocog alfa detected a statistically significant difference (P < 0.0001) between patients treated on regular prophylaxis (8.5 bleeds/year) and patients treated on an on-demand basis (36.6 bleeds/year). Favorable prophylactic and on-demand hemostatic efficacy (“excellent” or “good”) were shown in 88.5–100% of patients across all treatment regimens. A total of 22 events of adverse drug reactions were reported in 13 male patients. Of the 352 patients, 3 (0.9%) patients, all of whom had ≤ 50 exposure days before enrollment, developed de novo FVIII inhibitor. No deaths or allergic reactions were reported. Rurioctocog alfa was found to be well-tolerated and effective among patients with hemophilia A in a postmarketing routine clinical practice. More... »

PAGES

336-345

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-018-02574-x

DOI

http://dx.doi.org/10.1007/s12185-018-02574-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111058518

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30604312


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