Postmarketing surveillance study of KOGENATE Bayer with Bio-Set in patients with haemophilia A: evaluation of patients' satisfaction after switch to the new reconstitution system.
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| Abstract |
KOGENATE Bayer (rFVIII-FS) with Bio-Set is designed to prevent patient contact with exposed needles during recombinant factor VIII reconstitution. This postmarketing surveillance study evaluated patient satisfaction before and after switching to the new Bio-Set reconstitution method. Male children and adults with haemophilia A were enrolled from nine European countries. A preference questionnaire was administered to patients after Bio-Set training and at the end of the observation period (> or =20 exposure days or 3 months). Physician assessments of patient compliance and satisfaction were conducted at the end of the observation period. Patients (N = 306) received a mean +/- SD of 28 +/- 23 infusions of rFVIII-FS with Bio-Set. A majority of patients (82%) preferred the Bio-Set method, with domain scores for ease of use, safety from needlesticks, and speed of reconstitution being highest after training and at the end of the observation period. The Bio-Set method received higher mean scores than previous reconstitution methods for worry/safety and ease/confidence domains at both time points. Physician-reported patient compliance with the Bio-Set method was similar or greater compared with the previous method for 94% of the patients, with physicians reporting that 92% of the patients were satisfied or very satisfied with Bio-Set. Thirteen adverse events (AEs) occurred in nine patients, and five serious AEs occurred in five patients; none was related to rFVIII-FS. No de novo or recurrent inhibitor development was observed during the observation period. rFVIII-FS with Bio-Set was well tolerated and well accepted by haemophilia A patients, which may improve treatment compliance.
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| Authors | N Vidovic, R Musso, R Klamroth, M M Enriquez, K Achilles |
| Journal | Haemophilia : the official journal of the World Federation of Hemophilia (Haemophilia) Vol. 16 Issue 1 Pg. 66-71 (Jan 2010) ISSN: 1365-2516 [Electronic] England |
| PMID | 19878338 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't) |
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