Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors.
Bottom Line: The median (IQR) annualized bleeding rate (ABR) during prophylaxis was 7.9 (8.1), compared to 28.7 (32.3) during on-demand treatment, which amounts to a 72.5% reduction and a statistically significant difference in ABRs between arms (P = 0.0003).There were no differences in the rates of related adverse events between arms.This study demonstrates that FEIBA prophylaxis significantly reduces all types of bleeding compared with on-demand treatment, and the safety of prophylaxis is comparable to that of on-demand treatment.
Affiliation: UNIFESP, São Paulo, Brazil.Show MeSH
Related in: MedlinePlus
Mentions: During the 12-month study period, 196 bleeding episodes occurred during prophylaxis and 629 occurred during on-demand therapy. Three of the 17 (17.6%) prophylaxis subjects (ITT analysis set) were bleeding episode-free during the study; of these, two completed the study (12 months) and one was in study for 2.5 weeks. None of the 19 on-demand subjects were bleeding episode-free. The median (IQR) ABR for the on-demand arm was 28.7 (32.3) compared to 7.9 (8.1) for the prophylaxis arm, which amounts to a 72.5% reduction and a statistically significant difference in ABRs between arms (P = 0.0003, see Fig.2). These results support the primary objective of this study.