IDEAL study: A real‐world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX‐FP) in patients with haemophilia B in Italy

Introduction Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic...

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Published inHaemophilia : the official journal of the World Federation of Hemophilia Vol. 29; no. 1; pp. 135 - 144
Main Authors Tagliaferri, Annarita, Molinari, Angelo Claudio, Peyvandi, Flora, Coppola, Antonio, Demartis, Francesco, Biasoli, Chiara, Borchiellini, Alessandra, Cultrera, Dorina, De Cristofaro, Raimondo, Daniele, Filomena, Giordano, Paola, Marchesini, Emanuela, Margaglione, Maurizio, Marino, Renato, Pollio, Berardino, Radossi, Paolo, Santoro, Cristina, Santoro, Rita Carlotta, Siragusa, Sergio, Sottilotta, Gianluca, Tosetto, Alberto, Piscitelli, Lydia, Villa, Maria Rosaria, Zanon, Ezio, Finardi, Adele, Schiavetti, Irene, Vaccari, Daniella, Castaman, Giancarlo
Format Journal Article
LanguageEnglish
Published England Wiley Subscription Services, Inc 01.01.2023
John Wiley and Sons Inc
Subjects
ABR
Adult
Albumin
Albumins
annual consumption
Bleeding
Coagulation factor IX
Coagulation factors
Disease prevention
Dosage
extended half‐life FIX
Factor IX - therapeutic use
Factor IX deficiency
Fusion protein
Hemophilia
Hemophilia B - drug therapy
Hemorrhage - drug therapy
Hemorrhage - prevention & control
Humans
infusion frequency
Italy
Male
Original
Patients
Prophylaxis
Prospective Studies
real life
Recombinant Fusion Proteins - therapeutic use
Retrospective Studies
Trough levels
Italy
infusion frequency
ABR
Trough levels
real life
annual consumption
extended half-life FIX
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Abstract Introduction Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit. Aims To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX‐FP treatment during routine clinical practice in Italy. Methods Patients with moderate/severe haemophilia B on prophylaxis with rIX‐FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed‐up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX‐FP). Results Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2–3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX‐FP at the 2nd‐year follow‐up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX‐FP. Conclusion Treatment with rIX‐FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.
AbstractList IntroductionFactor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit.AimsTo describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX‐FP treatment during routine clinical practice in Italy.MethodsPatients with moderate/severe haemophilia B on prophylaxis with rIX‐FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed‐up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX‐FP).ResultsData were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2–3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX‐FP at the 2nd‐year follow‐up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX‐FP.ConclusionTreatment with rIX‐FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.
Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit.INTRODUCTIONFactor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit.To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX-FP treatment during routine clinical practice in Italy.AIMSTo describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX-FP treatment during routine clinical practice in Italy.Patients with moderate/severe haemophilia B on prophylaxis with rIX-FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed-up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX-FP).METHODSPatients with moderate/severe haemophilia B on prophylaxis with rIX-FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed-up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX-FP).Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2-3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX-FP at the 2nd-year follow-up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX-FP.RESULTSData were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2-3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX-FP at the 2nd-year follow-up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX-FP.Treatment with rIX-FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.CONCLUSIONTreatment with rIX-FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.
Introduction Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit. Aims To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX‐FP treatment during routine clinical practice in Italy. Methods Patients with moderate/severe haemophilia B on prophylaxis with rIX‐FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed‐up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX‐FP). Results Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2–3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX‐FP at the 2nd‐year follow‐up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX‐FP. Conclusion Treatment with rIX‐FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.
Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein, which, in clinical studies, has demonstrated prolonged dosing intervals up to 21 days for routine prophylaxis, providing therapeutic benefit. To describe dosing frequency and consumption (primary endpoint), efficacy and safety of rIX-FP treatment during routine clinical practice in Italy. Patients with moderate/severe haemophilia B on prophylaxis with rIX-FP for ≥6 months, were enrolled in this observational study from October 2017 to February 2019 and followed-up for 2 years. Descriptive analysis included prospective and retrospective data (12 months prior to switching to rIX-FP). Data were collected from 59 male patients (median age 30.1 years) enrolled by 23 Italian centres. Of them, 50 were on prophylaxis during the entire observation period and completed the study. The infusion frequency changed from 2-3 times/week in 86.0% of patients with previous treatment, to less than once a week in 84.0% of patients treated with rIX-FP at the 2nd-year follow-up. The annual number of infusions decreased by about 70%, whereas the mean FIX activity trough level increased from 3.8% to 14.4% (mean > 10% in all the infusion regimens). Median Annualised Bleeding Rate of .0 was achieved across all prophylaxis regimens. Subjects with zero bleedings increased from 66.0% to 78.0% with rIX-FP. Treatment with rIX-FP reduced infusion frequency, while providing higher FIX trough levels with substantial benefit in terms of annualised bleeding rate and a good safety profile.
Author De Cristofaro, Raimondo
Tosetto, Alberto
Santoro, Cristina
Piscitelli, Lydia
Marchesini, Emanuela
Peyvandi, Flora
Marino, Renato
Villa, Maria Rosaria
Molinari, Angelo Claudio
Giordano, Paola
Schiavetti, Irene
Tagliaferri, Annarita
Finardi, Adele
Vaccari, Daniella
Siragusa, Sergio
Biasoli, Chiara
Daniele, Filomena
Borchiellini, Alessandra
Margaglione, Maurizio
Radossi, Paolo
Coppola, Antonio
Castaman, Giancarlo
Sottilotta, Gianluca
Santoro, Rita Carlotta
Cultrera, Dorina
Pollio, Berardino
Demartis, Francesco
Zanon, Ezio
AuthorAffiliation 17 Regional Reference Centre for Haemophilia and Coagulation Diseases Azienda Ospedaliera Pugliese‐Ciaccio Catanzaro Italy
23 Department of Medicine Haemophilia Centre University Hospital of Padua Padua Italy
8 Haemorrhagic and Thrombotic Disease Service Area of Haematological and Oncological Sciences IRCCS Fondazione Policlinico Universitario “A. Gemelli” Rome Italy
16 Department of Haematology University Hospital Policlinico Umberto I Rome Italy
5 Haemophilia and Transfusion Centre “Bufalini” Hospital Cesena Italy
12 Department of Clinical and Experimental Medicine University of Foggia Foggia Italy
18 Haematology Unit Thrombosis and Haemostasis Reference Regional Centre University of Palermo Palermo Italy
11 Haemophilia Centre, Internal and Cardiovascular Medicine “Santa Maria della Misericordia” University Hospital Perugia Italy
2 Regional Reference Centre for Haemorrhagic Diseases IRCCS Istituto Giannina Gaslini Genova Italy
15 Onco‐Haematology Unit Istituto Oncologico Veneto Castelfranco V
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/36423202$$D View this record in MEDLINE/PubMed
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Issue 1
Keywords infusion frequency
ABR
Trough levels
real life
annual consumption
extended half-life FIX
Language English
License Attribution-NonCommercial
2022 CSL Behring S.p.A. Haemophilia published by John Wiley & Sons Ltd.
This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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Snippet Introduction Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion...
Factor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX-FP is an extended half-life albumin-fusion protein,...
IntroductionFactor IX replacement therapy is used for treatment and prophylaxis of bleeding in haemophilia B. rIX‐FP is an extended half‐life albumin‐fusion...
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SubjectTerms ABR
Adult
Albumin
Albumins
annual consumption
Bleeding
Coagulation factor IX
Coagulation factors
Disease prevention
Dosage
extended half‐life FIX
Factor IX - therapeutic use
Factor IX deficiency
Fusion protein
Hemophilia
Hemophilia B - drug therapy
Hemorrhage - drug therapy
Hemorrhage - prevention & control
Humans
infusion frequency
Italy
Male
Original
Patients
Prophylaxis
Prospective Studies
real life
Recombinant Fusion Proteins - therapeutic use
Retrospective Studies
Trough levels
Title IDEAL study: A real‐world assessment of pattern of use and clinical outcomes with recombinant coagulation factor IX albumin fusion protein (rIX‐FP) in patients with haemophilia B in Italy
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fhae.14689
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