Janssen Pharmaceutical has reported new data from the Phase III EINSTEIN-Jr clinical trial that assessed Xarelto (rivaroxaban) in treating venous thromboembolism (VTE) in paediatric patients.
According to the results, treatment with the drug resulted in a low recurrent VTE or blood clots risk and bleeding rates similar to those seen with current standard anticoagulation therapy.
In addition, the safety and efficacy profile of Xarelto was found comparable to that reported in prior adult patient studies.
Xarelto is a prescription medicine for reducing the risk of blood clots. The randomised, open-label EINSTEIN-Jr study compared the drug to standard anticoagulation therapy in 500 subjects.
It enrolled children aged up to 17 years who had acute VTE and were on heparin therapy at 107 sites across 28 countries.
The trial, which met all prespecified endpoints, evaluated symptomatic recurrent VTE as the primary efficacy outcome and composite of major and clinically relevant non-major bleeding as the primary safety outcome.
Data showed similar recurrent VTE in both treatment arms, while patients on Xarelto had numerically lower number of events. No fatal events were reported in either group.
Clinically relevant bleeding was also observed to be similar. Data revealed that 3% of the patients on Janssen’s drug experienced bleeding compared to 1.9% in the standard anticoagulation group.
The composite of recurrent VTE and major bleeding was reported in 1.2% of the Xarelto group versus 4.2% of the standard anticoagulation arm.
In addition, Xarelto led to a decrease in clot burden on imaging tests performed at baseline and at the end of the treatment period.
Janssen Research and Development Cardiovascular and Metabolism global therapeutic area head James List said: “VTE affects people of all ages, which is why we are committed to advancing new research and uncovering ways for Xarelto to help people in need.
“The EINSTEIN-Jr results offer important insights on the efficacy and safety of Xarelto in managing blood clots in our youngest patients.”
The EINSTEIN-Jr study, which was funded by Janssen and Bayer, is one of the five trials under the paediatric research programme for the drug in VTE.