Table 11.
Rate of total and high-titer inhibitors in PTPs and PUPs using rFVIII products in Italy.
| Recombinant product | Total incidence of inhibitors in PTPs (%) | Incidence of high-titer inhibitors in PTPs (%) | Total incidence of inhibitors in PUPs (%) | Incidence of high-titer inhibitors in PUPs (%) |
|---|---|---|---|---|
| Recombinate® (Baxter-Bioviiix): first-generation full-length rFVIII | 0.123a | 0.55 | 30.5a | 12.9 |
| ReFacto AF® (Pfizer): third-generation BDD-rFVIII | – | – | 33 | 14.5 |
| Advate AF® (Bayer): third generation full-length rFVIII | – | – | 29.1 | 12.7 |
| Kovaltry® (Bayer): third-generation full-length rFVIII | 0 | 0 | Ongoing LEOPOLD KIDs (Part B) study |
Ongoing LEOPOLD KIDs (Part B) study |
| Novoeight® (Novo Nordisk): third-generation BDT rFVIII | 0 | 0 | Ongoing guardian 4 study |
Ongoing guardian 4 study |
| Nuwiq® (Octapharma-Kedrion): third-generation BDD-rFVIII | 0 | 0 | 20.8 | 12.8 |
| Afstyla® (CSL Behring): third-generation single-chain rFVIII | 0 | 0 | Ongoing CSL627 UNDERSCORE 3001 extension study |
Ongoing CSL627 UNDERSCORE 3001 extension study |
| Elocta® (Biogen-Sobi): extended half-life BDD- rFVIIIb | 0 | 0 | 30.9 | 14.7b |
rFVIII, recombinant factor VIII; BDD, B-domain-deleted; PUPs, previously untreated patients; PTPs, previously treated patients.
a
Including high titer, low titer, and transient inhibitors.
b
Interim analysis of A LONG study PUPs.