Long‐term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B‐YOND extension study

Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG studies. However, long‐term rFIXFc safety and efficacy data have not yet been reported. Aim To report long‐term rFIXFc safety and efficacy in s...

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Published inHaemophilia : the official journal of the World Federation of Hemophilia Vol. 26; no. 6; pp. e262 - e271
Main Authors Pasi, K. John, Fischer, Kathelijn, Ragni, Margaret, Kulkarni, Roshni, Ozelo, Margareth C., Mahlangu, Johnny, Shapiro, Amy, P’Ng, Stephanie, Chambost, Hervé, Nolan, Beatrice, Bennett, Carolyn, Matsushita, Tadashi, Winding, Bent, Fruebis, Joachim, Yuan, Huixing, Rudin, Dan, Oldenburg, Johannes
Format Journal Article
LanguageEnglish
Published England Wiley Subscription Services, Inc 01.11.2020
Wiley
Subjects
bleed rate
Coagulation factors
extended half‐life
factor IX
Factor IX deficiency
Fc receptors
Fusion protein
haemophilia B
Hematology
Hemophilia
Human health and pathology
individualized prophylaxis
Life Sciences
Pediatrics
perioperative haemostasis
Prophylaxis
rFIXFc
Safety
factor IX
haemophilia B
bleed rate
rFIXFc
extended half-life
perioperative haemostasis
individualized prophylaxis
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Abstract Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG studies. However, long‐term rFIXFc safety and efficacy data have not yet been reported. Aim To report long‐term rFIXFc safety and efficacy in subjects with haemophilia B. Methods B‐YOND (NCT01425723) was an open‐label extension for eligibl previously treated subjects who completed B‐LONG or Kids B‐LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development. Results Ninety‐three subjects from B‐LONG and 27 from Kids B‐LONG (aged 3‐63 years) were enrolled. Most subjects received WP (B‐LONG: n = 51; Kids B‐LONG: n = 23). For subjects from B‐LONG, median (range) treatment duration was 4.0 (0.3‐5.4) years and median (range) number of exposure days (EDs) was 146 (8‐462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2‐3.9) years and 132 (50‐256) EDs. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended‐dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5). Conclusions B‐YOND results confirm the long‐term (up to 5 years, with cumulative duration up to 6.5 years) well‐characterized safety and efficacy of rFIXFc treatment for haemophilia B.
AbstractList Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported. To report long-term rFIXFc safety and efficacy in subjects with haemophilia B. B-YOND (NCT01425723) was an open-label extension for eligibl previously treated subjects who completed B-LONG or Kids B-LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development. Ninety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63 years) were enrolled. Most subjects received WP (B-LONG: n = 51; Kids B-LONG: n = 23). For subjects from B-LONG, median (range) treatment duration was 4.0 (0.3-5.4) years and median (range) number of exposure days (EDs) was 146 (8-462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2-3.9) years and 132 (50-256) EDs. No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended-dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5). B-YOND results confirm the long-term (up to 5 years, with cumulative duration up to 6.5 years) well-characterized safety and efficacy of rFIXFc treatment for haemophilia B.
Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported.INTRODUCTIONRecombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported.To report long-term rFIXFc safety and efficacy in subjects with haemophilia B.AIMTo report long-term rFIXFc safety and efficacy in subjects with haemophilia B.B-YOND (NCT01425723) was an open-label extension for eligibl previously treated subjects who completed B-LONG or Kids B-LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development.METHODSB-YOND (NCT01425723) was an open-label extension for eligibl previously treated subjects who completed B-LONG or Kids B-LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development.Ninety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63 years) were enrolled. Most subjects received WP (B-LONG: n = 51; Kids B-LONG: n = 23). For subjects from B-LONG, median (range) treatment duration was 4.0 (0.3-5.4) years and median (range) number of exposure days (EDs) was 146 (8-462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2-3.9) years and 132 (50-256) EDs. No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended-dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5).RESULTSNinety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63 years) were enrolled. Most subjects received WP (B-LONG: n = 51; Kids B-LONG: n = 23). For subjects from B-LONG, median (range) treatment duration was 4.0 (0.3-5.4) years and median (range) number of exposure days (EDs) was 146 (8-462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2-3.9) years and 132 (50-256) EDs. No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended-dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5).B-YOND results confirm the long-term (up to 5 years, with cumulative duration up to 6.5 years) well-characterized safety and efficacy of rFIXFc treatment for haemophilia B.CONCLUSIONSB-YOND results confirm the long-term (up to 5 years, with cumulative duration up to 6.5 years) well-characterized safety and efficacy of rFIXFc treatment for haemophilia B.
Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG studies. However, long‐term rFIXFc safety and efficacy data have not yet been reported. Aim To report long‐term rFIXFc safety and efficacy in subjects with haemophilia B. Methods B‐YOND (NCT01425723) was an open‐label extension for eligibl previously treated subjects who completed B‐LONG or Kids B‐LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development. Results Ninety‐three subjects from B‐LONG and 27 from Kids B‐LONG (aged 3‐63 years) were enrolled. Most subjects received WP (B‐LONG: n = 51; Kids B‐LONG: n = 23). For subjects from B‐LONG, median (range) treatment duration was 4.0 (0.3‐5.4) years and median (range) number of exposure days (EDs) was 146 (8‐462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2‐3.9) years and 132 (50‐256) EDs. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended‐dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5). Conclusions B‐YOND results confirm the long‐term (up to 5 years, with cumulative duration up to 6.5 years) well‐characterized safety and efficacy of rFIXFc treatment for haemophilia B.
Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported.Aim To report long-term rFIXFc safety and efficacy in subjects with haemophilia B.Methods B-YOND (NCT01425723) was an open-label extension for eligibl previously treated subjects who completed B-LONG or Kids B-LONG. Subjects received >= 1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development.Results Ninety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63 years) were enrolled. Most subjects received WP (B-LONG: n = 51; Kids B-LONG: n = 23). For subjects from B-LONG, median (range) treatment duration was 4.0 (0.3-5.4) years and median (range) number of exposure days (EDs) was 146 (8-462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2-3.9) years and 132 (50-256) EDs. No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended-dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5).Conclusions B-YOND results confirm the long-term (up to 5 years, with cumulative duration up to 6.5 years) well-characterized safety and efficacy of rFIXFc treatment for haemophilia B.
IntroductionRecombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG studies. However, long‐term rFIXFc safety and efficacy data have not yet been reported.AimTo report long‐term rFIXFc safety and efficacy in subjects with haemophilia B.MethodsB‐YOND (NCT01425723) was an open‐label extension for eligibl previously treated subjects who completed B‐LONG or Kids B‐LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development.ResultsNinety‐three subjects from B‐LONG and 27 from Kids B‐LONG (aged 3‐63 years) were enrolled. Most subjects received WP (B‐LONG: n = 51; Kids B‐LONG: n = 23). For subjects from B‐LONG, median (range) treatment duration was 4.0 (0.3‐5.4) years and median (range) number of exposure days (EDs) was 146 (8‐462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2‐3.9) years and 132 (50‐256) EDs. No inhibitors were observed (0 per 1000 subject‐years; 95% confidence interval, 0‐8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended‐dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5).ConclusionsB‐YOND results confirm the long‐term (up to 5 years, with cumulative duration up to 6.5 years) well‐characterized safety and efficacy of rFIXFc treatment for haemophilia B.
Author Ragni, Margaret
Mahlangu, Johnny
Oldenburg, Johannes
Kulkarni, Roshni
P’Ng, Stephanie
Yuan, Huixing
Winding, Bent
Pasi, K. John
Matsushita, Tadashi
Nolan, Beatrice
Rudin, Dan
Chambost, Hervé
Fischer, Kathelijn
Fruebis, Joachim
Shapiro, Amy
Bennett, Carolyn
Ozelo, Margareth C.
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Issue 6
Keywords factor IX
haemophilia B
bleed rate
rFIXFc
extended half-life
perioperative haemostasis
individualized prophylaxis
Language English
License Attribution-NonCommercial-NoDerivs
2020 The Authors. Haemophilia published by John Wiley & Sons Ltd.
Distributed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0
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Snippet Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG...
Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies....
IntroductionRecombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B‐LONG and Kids B‐LONG...
Introduction Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG...
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SubjectTerms bleed rate
Coagulation factors
extended half‐life
factor IX
Factor IX deficiency
Fc receptors
Fusion protein
haemophilia B
Hematology
Hemophilia
Human health and pathology
individualized prophylaxis
Life Sciences
Pediatrics
perioperative haemostasis
Prophylaxis
rFIXFc
Safety
Title Long‐term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B‐YOND extension study
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fhae.14036
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Volume 26
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