New Data Shows Improved Prophylactic Efficacy with Sobi’s Elocta

The annualized bleeding rate in patients with hemophilia A was significantly lower in the real world

Positive results from the Elocta – A-SURE – study were presented at the 30th Congress of the International Society on Thrombosis and Haemostasis (ISTH) in London.

They demonstrated improved prophylactic efficacy when patients used Swedish Orphan Biovitrum AB’s (Sobi) Elocta therapy.

A-SURE was a 24-month prospective non-interventional European multicenter study including more than 350 participants in 45 centers. This was the largest directly comparative study in people with haemophilia A. The results were reported by Professor Johannes Oldenburg, the study’s principal investigator.

The A-SURE study was designed with a matched control group in a prospective observational study and provided balanced and comparable study groups. Almost all patients had severe haemophilia and all patients had been on prophylaxis with a factor 8 product for at least 12 months prior to inclusion.

The results showed statistically significant improvements for all three primary endpoints. During this time, Elocta was well tolerated and met the established safety profile. Moreover, no inhibitors occurred, including in patients with a history of inhibitors.

“The results show that Eocta is significantly superior to SHL FVIII treatments on all three endpoints,” explained Professor Johannes Oldenburg, also Chairman of the Institute for Experimental Hematology and Transfusion Medicine.

“Furthermore, A-SURE’s real-world, direct-comparison study design is unique in the hemophilia field and provides a robust new addition for confidently making treatment decisions based on results,” he added.

“These new data further expand the already considerable body of evidence supporting Eocta’s potential to improve the protection of people with hemophilia A,” said Anders Ullman, Head of R&D and Chief Medical Officer at Sobi. “We remain committed to continuously strengthening the evidence for treatment. of hemophilia through clinical data and real-world outcomes. »

Hemophilia A is a rare genetic disease in which the ability of a person’s blood to clot is impaired due to a lack of factor 8. Hemophilia A occurs in approximately one in every 5,000 boys born per year and above rarely in women.

Sara H. Byrd