The following is an excerpt from a press release from Octapharma. Read the full press release here.
Octapharma announced the final results from the NuProtect study on the immunogenicity of Nuwiq® in previously untreated patients with severe hamophilia A have been published in the medical journal Thrombosis and Haemostasis (Liesner RJ et al. “Simoctocog Alfa (Nuwiq®) in Previously Untreated Patients with Severe Haemophilia A: Final Results of the NuProtect Study”).
The NuProtect study was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®. The study recruited patients of any age and ethnicity at 38 sites in 17 countries and followed patients for 100 exposure days or up to five years. With enrolment of 110 patients, the NuProtect study was the largest clinical study to investigate a single product in true PUPs.
Of 105 evaluable PUPs with severe hemophilia A who received Nuwiq® for the prevention and treatment of bleeding:
- 2% of patients developed high-titre inhibitors
- 5% (of patients developed low-titre inhibitors, five of which were transient
- 7% (of patients developed any inhibitor
“The NuProtect study showed that there was a low risk of inhibitor development in PUPs starting treatment with Nuwiq®,” commented Dr Ri Liesner, coordinating investigator of the NuProtect study and clinician at Great Ormond Street Hospital for Children in London, UK. “These data indicate Nuwiq® may be an attractive option for people newly diagnosed with severe hemophilia A, who are young children and represent a vulnerable patient subset.”
The development of inhibitors to replacement factor VIII (FVIII) is a concern for doctors, as well as for patients and their families, particularly when first starting treatment. Inhibitors render FVIII therapy ineffective and limit treatment options.
These data complement the wealth of clinical experience in patients with haemophilia A receiving Nuwiq® for the treatment and prevention of bleeding.