Annualized Bleeding Rates Reduced Using Treatment with Turoctocog Alfa

March 30, 2015
Rachel Lutz

Hemophilia Reports, March 2015, Volume 2, Issue 1

Turoctocog alfa reduced annualized bleeding rates in hemophilia A patients in a phase 3 clinical trial from Novo Nordisk.

Treatment with turoctocog alfa reduced the annualized bleeding rate (ABR) the most in patients with hemophilia A, drug maker Novo Nordisk announced in a press release.

NovoEight, a recombinant factor VIII drug from Novo Nordisk, was used in a phase 3 trial of patients with hemophilia A. The study, called the guardian™2 trial, was presented at the 56th Annual Meeting of the American Society of Hematology.

The guardian™ trial included more than 210 hemophilia A patients who were treated, and this guardtian™ 2 analysis is an extension of the original. This second trial included 166 patients who had previously participated in guardian™1 or 3, had a <=1 week of surgery in the guardian™1 or 3 (initial period), and had =>3 months of exposure to turoctocog alfa prophylaxis during the selected time period of January 2012 to June 2013 in the guardian™2 trial.

“This post hoc analysis gives an indication that patients with high baseline bleed rate can benefit from prophylaxis with NovoEight®, as well as patients who maintain low ABR,” said lead investigator Margareth Ozelo, MD, PhD, Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil.

In the analysis of the study, researchers found that with continued treatment with turoctocog alfa, adults and adolescents demonstrated reductions of 69 percent and 63 percent, respectively, in ABR from guardian™1 to guardian™2.

The guardian™1 and 3 trials demonstrated turoctocog alfa was efficacious in preventing and reducing bleeds without confirmed inhibitor development in 213 treatment naïve patients.

The most common adverse reactions found in the study were injection site reactions, increased hepatic enzymes, and fever.