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Inhibitor development, safety and efficacy of Advate® among previously treated patients with hemophilia A in a postmarketing surveillance in Japan
- Source :
- International Journal of Hematology. 109:336-345
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- Rurioctocog alfa (recombinant Factor VIII: AdvateⓇ) is available for the control of bleeding in patients with hemophilia A in Japan. To evaluate the immunogenicity, safety, and efficacy of prophylactic and on-demand use of rurioctocog alfa, postmarketing surveillance was conducted on 114 previously untreated Japanese patients aged 0–82 years with ≤ 3 exposure days under the conditions of routine clinical practice. A post-hoc comparison of mean annualized bleeding rates between patients in the regular prophylaxis group (7.4 bleeds/year) and in the on-demand treatment group (15.7 bleeds/year) using a negative binomial model found a statistically significant difference (P = 0.0164) in the subset of patients with severe hemophilia A. Favorable prophylactic and on-demand hemostatic efficacy (“excellent” or “good”) was shown in 71.4–88.5% across all treatment regimens. A total of 31 events of adverse drug reactions were reported. Of 114 patients, 21 (18.4%) developed de novo FVIII inhibitor; of these, 17 occurred within 50 exposures. One death was reported. A family history of positive inhibitors was significantly associated with inhibitor development (Fisher exact P value = 0.0004); no other risk factors were identified. Rurioctocog alfa was found to be well-tolerated and effective in previously untreated Japanese patients with hemophilia A in this postmarketing surveillance of routine clinical practice.
- Subjects :
- medicine.medical_specialty
Hematology
business.industry
Immunogenicity
Significant difference
Postmarketing surveillance
Recombinant factor viii
03 medical and health sciences
symbols.namesake
0302 clinical medicine
030220 oncology & carcinogenesis
Internal medicine
medicine
symbols
Family history
Previously treated
business
Fisher's exact test
030215 immunology
Subjects
Details
- ISSN :
- 18653774 and 09255710
- Volume :
- 109
- Database :
- OpenAIRE
- Journal :
- International Journal of Hematology
- Accession number :
- edsair.doi...........c465bfe3b4f44bef2f756d10a51f8c31