Why carry out this study?

Clinical trials are important to generate the robust efficacy and safety data required for subsequent approval of new therapies; however, when evaluating FIX products in clinical practice, real-world utilisation and outcomes also need to be considered.

The aim of this analysis was to evaluate real-world outcomes in patients switching to rIX-FP from the previous FIX product in Italy, Belgium and the UK.

What was learned from this study?

This study demonstrated that patients experienced reduced bleeding rates, factor consumption and dosing intervals following the switch to rIX-FP compared with their previous FIX product.

This real-world analysis further strengthens the rIX-FP clinical trial data, showing that the excellent haemostatic efficacy demonstrated in clinical trials is consistent with that seen in real-world clinical practice.