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Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A

Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A
Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A
The Phase 3 A-LONG and Kids A-LONG studies demonstrated the prolonged half-life of rFVIIIFc compared with rFVIII, and the safety and efficacy of rFVIIIFc in subjects with severe haemophilia A. Eligible subjects from A-LONG and Kids A-LONG continued rFVIIIFc treatment by enrolling in ASPIRE, an ongoing extension study. Based on combined data from the primary studies and ASPIRE interim data, the safety and efficacy of rFVIIIFc in subjects requiring surgery were evaluated. Perioperative dosing regimens were determined by investigators with guidance based on pharmacokinetic data and recommendations from a clinical dosing committee. In addition to dosing frequency, factor consumption, blood loss, transfusions, bleeding episodes, and haemostatic response were assessed. Across studies, 21 subjects underwent 23 evaluable major surgeries, including 19 orthopaedic surgeries; 41 subjects underwent 52 minor surgeries, including 30 dental procedures. No major and 10 minor surgeries were performed in paediatric subjects. Of the major (n = 22) and minor (n = 32) surgeries assessed for haemostatic response, all were rated as excellent or good by the investigator/surgeon. During most major surgeries (95.7 %), haemostasis was maintained with one rFVIIIFc infusion. Blood loss in major surgeries was consistent with similar surgeries in subjects without haemophilia. Across studies, rFVIIIFc was well tolerated; no subject developed an inhibitor.
0340-6245
1-8
Mahlangu, Johnny
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Ragni, Margaret
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Gupta, Naresh
a2ba37b2-9e67-44cf-af7a-54cabbd9bd2e
Rangarajan, Savita
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Klamroth, Robert
bd0b69ea-9c87-43d5-a10e-b87911b1daef
Oldenburg, Johannes
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Nogami, Keiji
dadf38e7-8c3f-41a6-afeb-b888f8ec0565
Young, Guy
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Cristiano, Lynda
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Dong, Yingwen
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Allen, Geoffrey
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Pierce, Glenn
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Robinson, Brian
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Mahlangu, Johnny
d9dbd61a-b94a-4fbc-812d-55c6434fbc09
Ragni, Margaret
4d645780-54d2-4f72-954e-7b57cfed1165
Gupta, Naresh
a2ba37b2-9e67-44cf-af7a-54cabbd9bd2e
Rangarajan, Savita
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Klamroth, Robert
bd0b69ea-9c87-43d5-a10e-b87911b1daef
Oldenburg, Johannes
64d59642-cce6-461f-a557-bb8fc982e367
Nogami, Keiji
dadf38e7-8c3f-41a6-afeb-b888f8ec0565
Young, Guy
a7d770f7-b217-4fe8-8051-7b88c7460f62
Cristiano, Lynda
b4fc68b8-3893-4909-b0dd-b1dfcfa206ab
Dong, Yingwen
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Allen, Geoffrey
a92039ed-f5de-4fd7-945b-359a80027dd8
Pierce, Glenn
fa4102f0-d5f8-465b-bb17-7b7e111225d1
Robinson, Brian
16aa8d37-8b4b-4426-91ac-47f9bfb30a04

Mahlangu, Johnny, Ragni, Margaret, Gupta, Naresh, Rangarajan, Savita, Klamroth, Robert, Oldenburg, Johannes, Nogami, Keiji, Young, Guy, Cristiano, Lynda, Dong, Yingwen, Allen, Geoffrey, Pierce, Glenn and Robinson, Brian (2016) Long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A. Thrombosis and Haemostasis, 116 (07), 1-8. (doi:10.1160/TH15-10-0780).

Record type: Article

Abstract

The Phase 3 A-LONG and Kids A-LONG studies demonstrated the prolonged half-life of rFVIIIFc compared with rFVIII, and the safety and efficacy of rFVIIIFc in subjects with severe haemophilia A. Eligible subjects from A-LONG and Kids A-LONG continued rFVIIIFc treatment by enrolling in ASPIRE, an ongoing extension study. Based on combined data from the primary studies and ASPIRE interim data, the safety and efficacy of rFVIIIFc in subjects requiring surgery were evaluated. Perioperative dosing regimens were determined by investigators with guidance based on pharmacokinetic data and recommendations from a clinical dosing committee. In addition to dosing frequency, factor consumption, blood loss, transfusions, bleeding episodes, and haemostatic response were assessed. Across studies, 21 subjects underwent 23 evaluable major surgeries, including 19 orthopaedic surgeries; 41 subjects underwent 52 minor surgeries, including 30 dental procedures. No major and 10 minor surgeries were performed in paediatric subjects. Of the major (n = 22) and minor (n = 32) surgeries assessed for haemostatic response, all were rated as excellent or good by the investigator/surgeon. During most major surgeries (95.7 %), haemostasis was maintained with one rFVIIIFc infusion. Blood loss in major surgeries was consistent with similar surgeries in subjects without haemophilia. Across studies, rFVIIIFc was well tolerated; no subject developed an inhibitor.

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More information

Accepted/In Press date: 28 February 2016
Published date: 2016

Identifiers

Local EPrints ID: 442894
URI: http://eprints.soton.ac.uk/id/eprint/442894
ISSN: 0340-6245
PURE UUID: 71fb8628-f021-4d55-9e1f-990c6400ab9e
ORCID for Savita Rangarajan: ORCID iD orcid.org/0000-0001-7367-133X

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Date deposited: 30 Jul 2020 16:31
Last modified: 28 Apr 2022 02:30

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Contributors

Author: Johnny Mahlangu
Author: Margaret Ragni
Author: Naresh Gupta
Author: Robert Klamroth
Author: Johannes Oldenburg
Author: Keiji Nogami
Author: Guy Young
Author: Lynda Cristiano
Author: Yingwen Dong
Author: Geoffrey Allen
Author: Glenn Pierce
Author: Brian Robinson

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