title: 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.
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.
authors.affiliation: Institut fuer Experimentelle Haematologie und Transfusionsmedizin, Universitaet Bonn, Bonn, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Vidovic
authors.forename: R
authors.initials: R
authors.lastname: Musso
authors.forename: R
authors.initials: R
authors.lastname: Klamroth
authors.forename: M M
authors.initials: MM
authors.lastname: Enriquez
authors.forename: K
authors.initials: K
authors.lastname: Achilles
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005169:Factor VIII / Q000008:administration & dosage* / Q000627:therapeutic use; D006467:Hemophilia A / Q000188:drug therapy*; D018718:Home Infusion Therapy / Q000379:methods*; D006801:Humans; D007223:Infant; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C078147:F8 protein, human; D005169:Factor VIII