Bayer and Janssen presented new results from the Phase 3 EINSTEIN-Jr study, showing pediatric patients (aged birth to 17 years) treated with Xarelto (rivaroxaban) had a similar low risk of recurrent venous thromboembolism (VTE)—or blood clots—and similar rates of bleeding when compared to current standard anticoagulation therapy. These results from the largest pediatric study ever conducted for the treatment of VTE also show that the efficacy and safety profile of Xarelto in a pediatric population with VTE is comparable to what has been observed in previous studies of adults with VTE. The full findings were presented during a late-breaking session at the 27th Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Melbourne, Australia.
EINSTEIN-Jr was a randomized, open-label study and included 500 children aged from birth to 17 years with documented acute VTE who had started heparin therapy. Children were assigned, in a 2:1 ratio, to receive body weight-adjusted rivaroxaban (tablets or suspension) in a 20 mg-equivalent dose, or standard of care with (low molecular weight) heparin or fondaparinux with or without vitamin K antagonist therapy. The main treatment period was 3 months, but children younger than 2 years with catheter-related VTE received 1 month of treatment. Repeat imaging was carried out at the end of the treatment period. Results were also interpreted in the context of previous studies evaluating rivaroxaban in adults with VTE.
Recurrent VTE occurred in 4 of the 335 (1.2%) children assigned to rivaroxaban and in 5 of the 165 (3.0%) children assigned to standard of care. Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard of care. Clinically relevant bleeding occurred in 10 children (3.0%; all non-major bleeds) with rivaroxaban and in 3 children (1.9%; two major and one non-major bleeds) with standard of care.
Bayer plans to submit an application to the European Medicines Agency (EMA) for the extension of the Xarelto marketing authorization to make this new treatment option, including the granules for oral suspension, available for children with venous thromboembolism.
About Venous Thromboembolism (VTE)
VTE includes cerebral vein and sinus thrombosis, a blood clot in the brain, pulmonary embolism (PE), a blood clot that travels to the lung, and deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs). VTE is an increasingly common complication among hospitalized children with the most common risk factor for VTE being venous catheterization. Currently recommended treatment options for VTE include unfractionated heparin, low molecular weight heparin, fondaparinux with or without vitamin K antagonist therapy. No non-vitamin K oral anticoagulant is currently approved for use in this setting.