FVIII inhibitor development according to concentrate : data from the EUHASS registry excluding overlap with other studies

Abstract

Recently, analyses on inhibitor development according to concentrate in previously untreated patients (PUPs) from two national cohort studies have been published. A similar analysis has been performed on the first 4 years of data collection of the European Haemophilia Safety Surveillance System (EUHASS) project. Together with the initial report from the RODIN study published in 2013 [4], these publications provide data on a very considerable number of patients, almost exclusively originating from Europe. Reporting to multiple registries is common, and a rare disease such as haemophilia is no exception. Although the FranceCoag study, the UKHCDO study and the EUHASS study excluded patients overlapping with the RODIN study from their analyses, the additional overlap between the EUHASS, the FranceCoag and UKHCDO studies has not been previously reported. The analysis of non-overlapping data from the EUHASS study has the potential to contribute to the ongoing discussion about the perceived increased inhibitor risk associated with the use of specific recombinant Factor VIII concentrates. Thus, we hereby provide additional analyses of the data from the EUHASS study.