Beriate® P in the treatment of patients with haemophilia A: Results of a long-term pharmacovigilance study

BackgroundThe German Beriate® P pharmacovigilance study started in 2003 and is planned to run until December 2013.Materials and methodsThis 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 0–101.9 months). 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.ResultsMost 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.ConclusionsThese 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.