title: Beriate® P in the treatment of patients with haemophilia A: results of a long-term pharmacovigilance study.
abstract: BACKGROUND
  The German Beriate(®) P pharmacovigilance study started in 2003 and is planned to run until December 2013.
  
  
  METHODS
  This analysis included data from 84 haemophilia A patients treated with the high-purity, plasma-derived coagulation factor VIII concentrate Beriate(®) P. Prior to study start, 69 of the 80 patients for whom data were available had received previous treatment with Beriate(®) P (mean treatment period 7.1 ± 5.4 years). The mean study duration from the start of pharmacovigilance was 43.3 ± 30.3 months (median 43.5 months; range 0-101.9months). The most common treatment at the last visit was prophylaxis (65.7% of patients), which was most commonly administered at a frequency of three infusions/week in 47.3% of patients.
  
  
  RESULTS
  Most patients experienced up to six minor bleeds/year. For 1,311 bleeding episodes, a median of one infusion/bleed was administered (mean 2.8 ± 4.7; range 0-83). The clinical response to Beriate(®) P was rated "excellent"/"good" in 94% of 32 visits of patients with major bleeding. The clinical response for patients with minor bleeding was rated "excellent"/"good" in 98.5% of 377 visits. One clinically relevant inhibitor in a previously untreated patient was documented during the study course. There were no reports of virus transmissions suspected to be caused by Beriate(®) P prior to the study start or during the study.
  
  
  CONCLUSIONS
  These findings confirm the excellent efficacy, safety, and tolerability of Beriate(®) P in the treatment of a wide spectrum of previously untreated patients up to adult patients with haemophilia A.
authors.affiliation: Hämophiliezentrum, Klinik für Innere Medizin - Angiologie, Hämostaseologie und Pneumologie, Vivantes-Klinikum im Friedrichshain, Berlin, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Klamroth
authors.affiliation: Klinik für Pädiatrische Hämatologie und Onkologie, Campus Virchow Klinikum, Universitätsklinikum Charité Berlin, Berlin, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Holzhauer
authors.affiliation: Hämophiliezentrum, Abteilung für. Innere Medizin, SRH Kurpfalzkrankenhaus, Heidelberg, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Zimmermann
authors.affiliation: Pädiatrische Hämostaseologie, Klinik für Kinderheilkunde-und Jugendmedizin, Universitätsklinikum Frankfurt am Main, Frankfurt am Main, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Heller
authors.affiliation: Zentrum für Pädiatrische Hämostaseologie, Ludwig-Maximilian Universität, Klinikum der Universität, Campus Innenstadt, Munich, Germany. Electronic address: Karin.Kurnik@med.uni-muenchen.de.
authors.forename: Karin
authors.initials: K
authors.lastname: Kurnik
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D005169:Factor VIII / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D006470:Hemorrhage / Q000150:complications; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010949:Plasma / Q000821:virology; D011446:Prospective Studies; D055815:Young Adult; D014841:von Willebrand Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; C509423:factor VIII, von Willebrand factor drug combination; D014841:von Willebrand Factor; D005169:Factor VIII
keywords: Beriate(®) P; Efficacy; Haemophilia A; Inhibitors; Pharmacovigilance; Safety