ADVATE Safety ADVATE Safety

low risk of inhibitor development in PTPs with advate

Inhibitor development has been seen with all FVIII products, including ADVATE [Octocog alfa (Recombinant Coagulation Factor VIII)]

ADVATE Safety Inhibitor Rate

Clinical development spanning over a decade in previously treated patients (PTPs) with moderately severe to severe haemophilia A1-7:

(95% confidence interval, 0.009%-2.002%7)

1 inhibitor

(low-titre, non-persistent)7

276 ptps

with ≥10 EDs7

proven real-world experience

Safety in PTPs

ADVATE [Octocog alfa (Recombinant Coagulation Factor VIII)] Post-Authorisation Safety Surveillance (PASS) programme (N=1188) was designed to determine the safety profile and effectiveness of ADVATE under conditions of routine clinical practice (as opposed to the carefully controlled setting of an investigational trial)8:

ADVATE Safety in PTPs

0.15%

Incidence of de novo inhibitor development in PTPs with severe haemophilia A.*8

All inhibitors in severe PTPs (n=774) were 11.8

*1.5 per 1000 with Cl:0.2, 10.6 per 1000.

study details8

  • Five PASS studies followed 1188 haemophilia A patients with FVIII <5% for a median of 384 days
  • Primary outcome: Evaluation of de novo inhibitors in PTPs with severe haemophilia A (FVIII <1%) and >150 exposure days at enrolment
  • Secondary outcomes included evaluation of de novo and all observed inhibitors according to prior exposure and disease severity, and effectiveness in terms of ABR in all patients
  • Less than 1% of patients enrolled in the ADVATE-PASS studies presented with a non-inhibitor AE related to the product:
    • Five serious AEs in 5 patients were reported as product related: 2 hypersensitivity reactions (oedema and exanthema), 1 cerebral haemorrhage, 1 anaemia and abnormal hepatic function, and 1 anxiety

safety in pups

ADVATE Safety in PUPs

These studies demonstrated the extensive real-world experience of ADVATE in previously untreated patients (PUPs) and adds to the wealth of safety data.9-11

Study Details12

A prospective trial of 55 previously untreated and minimally treated patients that studied the immunogenicity, efficacy, and safety of ADVATE found that 29% of those patients developed inhibitors.12