Data at EAHAD 2021 Highlight Value of Takeda’s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements
− Seven Year Data Reinforce Long-term Efficacy and Safety Review of ADVATE (Antihemophilic Factor [Recombinant])
− Abstracts Support Use of Real World Evidence to Advance Treatment and Patient Outcomes
− Takeda’s Heritage in Bleeding Disorders and Commitment to Investing in Innovation Support Our Passion for Helping Patients and Our Vision of a Bleed-free World
Osaka, Japan, February 3, 2021 – Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“Takeda”) today announced that 14 abstracts from the company’s Hematology portfolio and pipeline are being presented as electronic posters at the Virtual European Association for Haemophilia and Allied Disorders Congress (EAHAD 2021). Data include multiple abstracts reinforcing the long-term efficacy and safety of Takeda’s hematology portfolio in clinical practice, supporting the value of these treatments in a real world setting.
Seven year AHEAD study data [ABS034] showed that prophylactic antihemophilic factor (recombinant), rAHF (ADVATE), achieved lower annualized bleeding rates (ABRs) and annualized joint bleeding rates (AJBRs) than on-demand treatment in all patients with severe hemophilia A. Key outcomes included ABRs (all bleeds), AJBRs, joint health (evaluated by Gilbert score), and adverse events (AEs). AEs occurred in 414/702 (59.0%) patients (serious AEs in 141/702). 12 patients developed de novo FVIII inhibitors (high titer [>5 BU], n=2 [transient]; low titer [≤5 BU], n=10 [1 transient, 9 persistent]. A separate analysis of patients with moderate or severe hemophilia A and target joints [ABS170] showed that prophylactic rAHF maintained lower bleed rates than on-demand treatment over seven years.
A further retrospective study [ABS039] investigated the impact of switching patients with moderate or severe hemophilia A in US clinical practice (without inhibitors) from Factor VIII prophylaxis to rurioctocog alfa pegol (ADYNOVATE) or emicizumab. Results showed that there were no statistically significant differences in prophylactic effectiveness between treatments.
“For rare diseases such as hemophilia, gathering evidence from clinical practice is crucial to advance treatment and reduce gaps in patient care,” commented Professor Margareth Ozelo, Director of the WFH International Haemophilia Training Centre, University of Campinas, Brazil. “These data add to the body of evidence for the management of hemophilia, and reinforce the value of using evidence from real world settings to personalized care, improve patient outcomes, and address the unique needs of every single patient.”
Additional abstracts presented at EAHAD 2021 further reinforce the efficacy and safety of Takeda’s portfolio for both on-demand and prophylaxis treatment in real world settings [ABS093, ABS113, ABS181, ABS070, ABS112], illustrate the benefit of PK-guided, personalized prophylaxis to help support patient outcomes in hemophilia [ABS120, ABS190], and demonstrate our ongoing commitment to innovation in hematology [ABS185].