No Factor VIII inhibitors were detected during the XTEND-Kids study1*
Primary endpoint: Incidence of neutralizing antibodies to Factor VIII2
0.0% (95% Cl: 0.0-4.9)2
Formation of inhibitors to Factor VIII is possible following administration of ALTUVIIIO.1
* Defined as an inhibitor of ≥0.6 BU/mL and confirmed by a second test result from a separate sample drawn 2 to 4 weeks following the date of the original sample.2
Effective bleed protection with a once-weekly infusion1
In the XTEND-Kids trial:
ALTUVIIIO demonstrated proven bleed protection in children <12 years (n=72)*
0.0 Median ABR
(Q1, Q3: 0.0, 1.0)
0.6 Mean ABR
(95% Cl: 0.4-0.9)
* Based on treated bleeds.
Most patients experienced zero bleeds when treated with ALTUVIIIO prophylaxis1
In the XTEND-Kids trial*:
Zero bleeds
63.9% of patients (n=46/72) had zero bleeds
Zero spontaneous bleeds
87.5% of patients (n=63/72) had zero spontaneous bleeds
Zero joint bleeds
83.3% of patients (n=60/72) had zero joint bleeds
* Based on treated bleeds.
Effective on-demand bleed management with only 1 infusion1
Treatment of bleeding episodes in the XTEND-Kids trial1,2
95.3% of bleeds* resolved with 1 infusion (n=41/43)
* Percentage based on the number of treated bleeding episodes in the sensitivity analysis set, which excluded two patients.1,2
Safety from the pediatric study
Find out more about the ALTUVIIIO safety profile in the XTEND-Kids clinical trial.
Learn the mechanism of ALTUVIIIO
Discover more about this high sustained factor therapy in pediatric patients.
Indication
ABR=annualized bleed rate; BU=Bethesda unit; CI=confidence interval; IU=international unit; Q1=25th percentile; Q3=75th percentile.
References: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 2. Malec L, et al. Efanesoctocog Alfa Prophylaxis for Previously Treated Patients <12 Years of Age With Severe Hemophilia A. Oral presentation at: 2023 International Society on Thrombosis and Haemostasis (ISTH); June, 2023; Montreal, Canada.
