Long-term confidence

A comparative study of PK profiles shows higher plasma levels for longer with ELOCTA vs standard half-life rFVIII*,1

  • On average, 50% more time to target trough levels vs standard half-life rFVIII in A-LONG (P<0.001)†,1
Data

ELOCTA® can give people with haemophilia the confidence to actively participate in a life full of possibilities

FVIII; Factor VIII; IU, international units; PK, pharmacokinetics; rFVIII, recombinant Factor VIII.

*As shown in A-LONG trial, sequential PK analysis demonstrated higher factor levels for ELOCTA than standard half-life rFVIII, at any given time point at equal doses.1

†Times to 1 and 3 IU/dL above baseline (95% CI) were 4.9 (4.4-5.5) and 3.7 (3.3-4.1) days for ELOCTA vs 3.3 (3.0-3.7) and 2.5 (2.2-2.7) days for rFVIII, respectively (P<0.001).

Reference 

1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25

Effective prevention of bleeds is key, but acute bleeds may occur in patients on prophylaxis and need effective and fast control
 

Most acute bleeds in A-LONG were resolved with just one injection of ELOCTA*,1

Data

ELOCTA® has shown to effectively prevent bleeds as well as to resolve acute and traumatic bleeds when required2

*All bleeds in all trial groups (prophylaxis/on-demand treatment).

References

1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.  

2. ELOCTA Summary of Product Characteristics. 2019.

Robust surgical data from the pivotal ELOCTA® trials (A-LONG and Kids A-LONG)1 and the ASPIRE extension trial (final data cut analysis)2 are available

 

The most common major surgeries included: unilateral knee (n=15); elbow (n=4) and ankle (n=4) arthroplasties; arthroscopy (n=3), appendectomy (n=2); laparoscopic herniorrhaphy (n=2); thoracotomy (n=2); spinal surgery (n=2); ureteroscopy (n=2)2

Data
Data

Prophylaxis with ELOCTA® provides perioperative haemostatic control across a wide spectrum of major and minor surgeries in subjects of all ages with severe haemophilia A1,2

*One major surgery did not have information on ELOCTA dosing on the day of surgery. One major surgery did not use ELOCTA on the day of surgery.

†Six minor surgeries did not use ELOCTA on the day of surgery.

Effective haemostatic response2,3
Icon
  • Haemostatic response to ELOCTA prophylaxis during surgery was rated as excellent or good in 100% of major (n=42/42) and minor (n=65/65) surgeries2
  • Zero serious vascular thrombotic events2
  • Zero adverse events were judged to be related to ELOCTA2

ELOCTA® was well-tolerated and efficacious in the perioperative management of major and minor surgeries2

References 

1.     Mahlangu JN, Ragni M, Gupta N, Rangarajana S, Klamroth R, Oldenburg J, et al. Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A. Thromb Haemost 2016;116(01):1-8. 

2.     Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.

3.     ELOCTA Summary of Product Characteristics. 2019.

8-year clinical trial programme supported by >5 years of real-world experience in switching from prophylaxis with standard half-life rFVIII to ELOCTA®1-3

 

  • A retrospective UK switch study of patients switching from standard half-life (SHL) rFVIII to ELOCTA (n=81) showed reductions in median injection frequency (from 3.2 to 2.3 infusions/week) and factor consumption (from 79 to 69 units/Kg/wk)*,4
  • In another retrospective US switch study (n=17), the joint ABR was reduced from 1.8 on standard half-life rFVIII to 0.71 on ELOCTA†,5
  • Real-world evidence suggests that ELOCTA can reduce injection frequency, factor consumption and bleed rates, as well as improve quality of life compared with SHL rFVIII therapy4-9

Real-world experience shows there are benefits in switching patients from prophylaxis with standard half-life rFVIII to ELOCTA® 

ABR, annualised bleeding rate; rFVIII, recombinant Factor VIII.

*Data from the UK National Haemophilia Database, all UK patients switching from rFVIII to rFVIIIFc prophylaxis, 01/09/16 - 31/03/19 were identified. A within-patient comparison was conducted in patients with ≥12-months pre-switch and 6-months post-switch, compliant Haemtrack (HT) data.4
†Retrospective review of existing medical records of patients with haemophilia A who had been prescribed ELOCTA was conducted from the Children’s Hospital Los Angeles Haemostasis and Thrombosis Centre database.5

References 

1. FDA. Eloctate® (rFVIIIFc) Prescribing Information.  https://www.fda.gov/media/88746/download. Last accessed, May 2019.

2. ELOCTA Summary of Product Characteristics. 2019.

3. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

4. Scott M, Wall C, Xiang H, Collins P, et al. A within-patient and matched-pair comparison of real-world outcomes in patients using rFVIII and rFVIIIFc prophylaxis, in the UK. Abstract presented at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2020 Feb 5-7; The Hague, Netherlands. P073.  

5. Wang C, Young G. Clinical use of recombinant factor VIII Fc and recombinant factor IX Fc in patients with haemophilia A and B. Haemophilia. 2018 May; 24(3):414–19.

6. Tagliaferri A, Quintavalle G, Riccardi F, Matichecchia A, Benegiamo A, Rossi R. Benefits of switch to FVIII-FC: Experience of prophylaxis in eight patients. Abstract presented at the 9th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2018 Feb 7–9; Madrid, Spain. P051.

7. Jimenez R, Nunez R, Jimenez P, Rodriguez-Martorelli FJ, Perez-Simon JA. Switch to extended half-life recombinant factor VIII FC in severe hemophilia A patients under prophylaxis. Experience in one centre. Abstract presented at the 9th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2018 Feb 7–9; Madrid, Spain. P176.

8. Peyvandi F, Garagiola I, Boscarino M, Ryan A, et al. Real-life experience in switching to new extended half-life products at European haemophilia centres. Haemophilia 2019;25(6):946-952.

9. Wang M, Alvarez-Roman MT, Chowdary P, Quon DV, Schafer K. Physical activity in individuals with haemophilia and experience with recombinant factors VIII FC fusion protein and recombinant factor IX Fc fusion protein for the treatment of active patients: a literature review and case reports. Blood Coagul Fibrinolysis 2016;27(27):737-744.

Long-term confidence

A comparative study of PK profiles shows higher plasma levels for longer with ELOCTA vs standard half-life rFVIII*,1

  • On average, 50% more time to target trough levels vs standard half-life rFVIII in A-LONG (P<0.001)†,1
Data

ELOCTA® can give people with haemophilia the confidence to actively participate in a life full of possibilities

FVIII; Factor VIII; IU, international units; PK, pharmacokinetics; rFVIII, recombinant Factor VIII.

*As shown in A-LONG trial, sequential PK analysis demonstrated higher factor levels for ELOCTA than standard half-life rFVIII, at any given time point at equal doses.1

†Times to 1 and 3 IU/dL above baseline (95% CI) were 4.9 (4.4-5.5) and 3.7 (3.3-4.1) days for ELOCTA vs 3.3 (3.0-3.7) and 2.5 (2.2-2.7) days for rFVIII, respectively (P<0.001).

Reference 

1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25

Effective prevention of bleeds is key, but acute bleeds may occur in patients on prophylaxis and need effective and fast control
 

Most acute bleeds in A-LONG were resolved with just one injection of ELOCTA*,1

Data

ELOCTA® has shown to effectively prevent bleeds as well as to resolve acute and traumatic bleeds when required2

*All bleeds in all trial groups (prophylaxis/on-demand treatment).

References

1. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.  

2. ELOCTA Summary of Product Characteristics. 2019.

Robust surgical data from the pivotal ELOCTA® trials (A-LONG and Kids A-LONG)1 and the ASPIRE extension trial (final data cut analysis)2 are available

 

The most common major surgeries included: unilateral knee (n=15); elbow (n=4) and ankle (n=4) arthroplasties; arthroscopy (n=3), appendectomy (n=2); laparoscopic herniorrhaphy (n=2); thoracotomy (n=2); spinal surgery (n=2); ureteroscopy (n=2)2

Data
Data

Prophylaxis with ELOCTA® provides perioperative haemostatic control across a wide spectrum of major and minor surgeries in subjects of all ages with severe haemophilia A1,2

*One major surgery did not have information on ELOCTA dosing on the day of surgery. One major surgery did not use ELOCTA on the day of surgery.

†Six minor surgeries did not use ELOCTA on the day of surgery.

Effective haemostatic response2,3
Icon
  • Haemostatic response to ELOCTA prophylaxis during surgery was rated as excellent or good in 100% of major (n=42/42) and minor (n=65/65) surgeries2
  • Zero serious vascular thrombotic events2
  • Zero adverse events were judged to be related to ELOCTA2

ELOCTA® was well-tolerated and efficacious in the perioperative management of major and minor surgeries2

References 

1.     Mahlangu JN, Ragni M, Gupta N, Rangarajana S, Klamroth R, Oldenburg J, et al. Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A. Thromb Haemost 2016;116(01):1-8. 

2.     Chowdary P, Ragni MV, Pabinger I, Feng J, Lethagan S, Barnowski C, Mahlangu JN. Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A. Poster preseted at the World Federation of Hemophilia 16th International Musculoskeletal Congress, May 10–12, 2019, Madrid, Spain. P-14.

3.     ELOCTA Summary of Product Characteristics. 2019.

8-year clinical trial programme supported by >5 years of real-world experience in switching from prophylaxis with standard half-life rFVIII to ELOCTA®1-3

 

  • A retrospective UK switch study of patients switching from standard half-life (SHL) rFVIII to ELOCTA (n=81) showed reductions in median injection frequency (from 3.2 to 2.3 infusions/week) and factor consumption (from 79 to 69 units/Kg/wk)*,4
  • In another retrospective US switch study (n=17), the joint ABR was reduced from 1.8 on standard half-life rFVIII to 0.71 on ELOCTA†,5
  • Real-world evidence suggests that ELOCTA can reduce injection frequency, factor consumption and bleed rates, as well as improve quality of life compared with SHL rFVIII therapy4-9

Real-world experience shows there are benefits in switching patients from prophylaxis with standard half-life rFVIII to ELOCTA® 

ABR, annualised bleeding rate; rFVIII, recombinant Factor VIII.

*Data from the UK National Haemophilia Database, all UK patients switching from rFVIII to rFVIIIFc prophylaxis, 01/09/16 - 31/03/19 were identified. A within-patient comparison was conducted in patients with ≥12-months pre-switch and 6-months post-switch, compliant Haemtrack (HT) data.4
†Retrospective review of existing medical records of patients with haemophilia A who had been prescribed ELOCTA was conducted from the Children’s Hospital Los Angeles Haemostasis and Thrombosis Centre database.5

References 

1. FDA. Eloctate® (rFVIIIFc) Prescribing Information.  https://www.fda.gov/media/88746/download. Last accessed, May 2019.

2. ELOCTA Summary of Product Characteristics. 2019.

3. Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan;123(3):317–25.

4. Scott M, Wall C, Xiang H, Collins P, et al. A within-patient and matched-pair comparison of real-world outcomes in patients using rFVIII and rFVIIIFc prophylaxis, in the UK. Abstract presented at the 13th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2020 Feb 5-7; The Hague, Netherlands. P073.  

5. Wang C, Young G. Clinical use of recombinant factor VIII Fc and recombinant factor IX Fc in patients with haemophilia A and B. Haemophilia. 2018 May; 24(3):414–19.

6. Tagliaferri A, Quintavalle G, Riccardi F, Matichecchia A, Benegiamo A, Rossi R. Benefits of switch to FVIII-FC: Experience of prophylaxis in eight patients. Abstract presented at the 9th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2018 Feb 7–9; Madrid, Spain. P051.

7. Jimenez R, Nunez R, Jimenez P, Rodriguez-Martorelli FJ, Perez-Simon JA. Switch to extended half-life recombinant factor VIII FC in severe hemophilia A patients under prophylaxis. Experience in one centre. Abstract presented at the 9th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD); 2018 Feb 7–9; Madrid, Spain. P176.

8. Peyvandi F, Garagiola I, Boscarino M, Ryan A, et al. Real-life experience in switching to new extended half-life products at European haemophilia centres. Haemophilia 2019;25(6):946-952.

9. Wang M, Alvarez-Roman MT, Chowdary P, Quon DV, Schafer K. Physical activity in individuals with haemophilia and experience with recombinant factors VIII FC fusion protein and recombinant factor IX Fc fusion protein for the treatment of active patients: a literature review and case reports. Blood Coagul Fibrinolysis 2016;27(27):737-744.