Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children
Identifieur interne : 001B85 ( Main/Curation ); précédent : 001B84; suivant : 001B86Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children
Auteurs : Gili Kenet [Israël] ; Hervé Chambost [France] ; Christoph Male [Autriche] ; Thierry Lambert [France] ; Susan Halimeh [Allemagne] ; Tatiana Chernova [Russie] ; Maria Elisa Mancuso [Italie] ; Julie Curtin [Australie] ; Christine Voigt [États-Unis] ; Yanyan Li [États-Unis] ; Iris Jacobs [États-Unis] ; Elena Santagostino [Italie]Source :
- Thrombosis and Haemostasis [ 0340-6245 ] ; 2016.
Abstract
A global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1–11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any bleeding episodes on-demand. The mean terminal half-life of rIX-FP was 91.4 hours (h), 4.3-fold longer than previous FIX treatment and clearance was 1.11 ml/h/kg, 6.4-fold slower than previous FIX treatment. The median (Q1, Q3) annualised spontaneous bleeding rate was 0.00 (0.00, 0.91) and was similar between the <6 years and ≥6 years age groups, with a weekly median prophylactic dose of 46 IU/kg. In addition, patients maintained a median trough level of 13.4 IU/dl FIX activity on weekly prophylaxis. Overall, 97.2% of bleeding episodes were successfully treated with one or two injections of rIX-FP (95% CI: 92% to 99%), 88.7% with one injection, and 96% of the treatments were rated effective (excellent or good) by the Investigator. No patient developed FIX inhibitors and no safety concerns were identified. These results indicate that rIX-FP is safe and effective for preventing and treating bleeding episodes in children with haemophilia B with weekly prophylaxis. Routine prophylaxis with rIX-FP at treatment intervals of up to 14 days are currently being investigated in children with severe and moderately severe haemophilia B. Clinicaltrials.gov (NCT01662531)
Url:
DOI: 10.1160/TH16-03-0179
PubMed: 27583313
PubMed Central: 5039316
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wicri:level="1"><nlm:aff id="aff002">Pediatric Hematology Oncology Department,<institution>Children Hospital La Timone, APHM, Aix Marseille University</institution>,<addr-line>Marseille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Marseille</wicri:regionArea></affiliation></author><author><name sortKey="Male, Christoph" sort="Male, Christoph" uniqKey="Male C" first="Christoph" last="Male">Christoph Male</name><affiliation wicri:level="1"><nlm:aff id="aff003">Department of Pediatrics,<institution>Medical University of Vienna</institution>,<addr-line>Vienna, Austria</addr-line></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Lambert, Thierry" sort="Lambert, Thierry" uniqKey="Lambert T" first="Thierry" last="Lambert">Thierry Lambert</name><affiliation wicri:level="3"><nlm:aff id="aff004"><institution>Centre de Traitement des ’Hémophilies</institution>,<addr-line>Hôpital Bicetre, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Bicetre, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Halimeh, Susan" sort="Halimeh, Susan" uniqKey="Halimeh S" first="Susan" last="Halimeh">Susan Halimeh</name><affiliation wicri:level="1"><nlm:aff id="aff005"><institution>CRC Coagulation Research Centre GmbH</institution>,<addr-line>Duisburg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Duisburg</wicri:regionArea></affiliation></author><author><name sortKey="Chernova, Tatiana" sort="Chernova, Tatiana" uniqKey="Chernova T" first="Tatiana" last="Chernova">Tatiana Chernova</name><affiliation wicri:level="1"><nlm:aff id="aff006"><institution>Kirov Research Institute of Hematology and Blood Transfusion</institution>,<addr-line>Kirov, Russia</addr-line></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>Kirov</wicri:regionArea></affiliation></author><author><name sortKey="Mancuso, Maria Elisa" sort="Mancuso, Maria Elisa" uniqKey="Mancuso M" first="Maria Elisa" last="Mancuso">Maria Elisa Mancuso</name><affiliation wicri:level="1"><nlm:aff id="aff007"><institution>Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico</institution>,<addr-line>Milan, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Milan</wicri:regionArea></affiliation></author><author><name sortKey="Curtin, Julie" sort="Curtin, Julie" uniqKey="Curtin J" first="Julie" last="Curtin">Julie Curtin</name><affiliation wicri:level="1"><nlm:aff id="aff008"><institution>Children’s Hospital at Westmead, Sydney Children’s Hospital Network</institution>,<addr-line>Sydney, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney</wicri:regionArea></affiliation><affiliation><nlm:aff id="aff009"><institution>Discipline of Paediatrics and Child Health, University of Sydney</institution>,<addr-line>Australia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Voigt, Christine" sort="Voigt, Christine" uniqKey="Voigt C" first="Christine" last="Voigt">Christine Voigt</name><affiliation wicri:level="1"><nlm:aff id="aff010"><institution>CSL Behring, CRD, King of Prussia</institution>,<addr-line>Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Li, Yanyan" sort="Li, Yanyan" uniqKey="Li Y" first="Yanyan" last="Li">Yanyan Li</name><affiliation wicri:level="1"><nlm:aff id="aff010"><institution>CSL Behring, CRD, King of Prussia</institution>,<addr-line>Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Jacobs, Iris" sort="Jacobs, Iris" uniqKey="Jacobs I" first="Iris" last="Jacobs">Iris Jacobs</name><affiliation wicri:level="1"><nlm:aff id="aff010"><institution>CSL Behring, CRD, King of Prussia</institution>,<addr-line>Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Santagostino, Elena" sort="Santagostino, Elena" uniqKey="Santagostino E" first="Elena" last="Santagostino">Elena Santagostino</name><affiliation wicri:level="1"><nlm:aff id="aff007"><institution>Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico</institution>,<addr-line>Milan, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Milan</wicri:regionArea></affiliation></author></analytic><series><title level="j">Thrombosis and Haemostasis</title><idno type="ISSN">0340-6245</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><p>A global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1–11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any bleeding episodes on-demand. The mean terminal half-life of rIX-FP was 91.4 hours (h), 4.3-fold longer than previous FIX treatment and clearance was 1.11 ml/h/kg, 6.4-fold slower than previous FIX treatment. The median (Q1, Q3) annualised spontaneous bleeding rate was 0.00 (0.00, 0.91) and was similar between the <6 years and ≥6 years age groups, with a weekly median prophylactic dose of 46 IU/kg. In addition, patients maintained a median trough level of 13.4 IU/dl FIX activity on weekly prophylaxis. Overall, 97.2% of bleeding episodes were successfully treated with one or two injections of rIX-FP (95% CI: 92% to 99%), 88.7% with one injection, and 96% of the treatments were rated effective (excellent or good) by the Investigator. No patient developed FIX inhibitors and no safety concerns were identified. These results indicate that rIX-FP is safe and effective for preventing and treating bleeding episodes in children with haemophilia B with weekly prophylaxis. Routine prophylaxis with rIX-FP at treatment intervals of up to 14 days are currently being investigated in children with severe and moderately severe haemophilia B. Clinicaltrials.gov (NCT01662531)</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bolton Maggs, Phb" uniqKey="Bolton Maggs P">PHB Bolton-Maggs</name></author><author><name sortKey="Pasi, Kj" uniqKey="Pasi K">KJ. Pasi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Srivastava, A" uniqKey="Srivastava A">A Srivastava</name></author><author><name sortKey="Brewer, Ak" uniqKey="Brewer A">AK Brewer</name></author><author><name sortKey="Mauser Bunschoten, Ep" uniqKey="Mauser Bunschoten E">EP Mauser-Bunschoten</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Santagostino, E" uniqKey="Santagostino E">E Santagostino</name></author><author><name sortKey="Mancuso, Me" uniqKey="Mancuso M">ME. Mancuso</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Santagostino, E" uniqKey="Santagostino E">E Santagostino</name></author><author><name sortKey="Negrier, C" uniqKey="Negrier C">C Negrier</name></author><author><name sortKey="Klamroth, R" uniqKey="Klamroth R">R Klamroth</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Martinowitz, U" uniqKey="Martinowitz U">U Martinowitz</name></author><author><name sortKey="Lissitchkov, T" uniqKey="Lissitchkov T">T Lissitchkov</name></author><author><name sortKey="Lubetsky, A" uniqKey="Lubetsky A">A Lubetsky</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Verbruggen, B" uniqKey="Verbruggen B">B Verbruggen</name></author><author><name sortKey="Novakova, I" uniqKey="Novakova I">I Novakova</name></author><author><name sortKey="Wessels, H" uniqKey="Wessels H">H Wessels</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Windyga, J" uniqKey="Windyga J">J Windyga</name></author><author><name sortKey="Lissitchkov, T" uniqKey="Lissitchkov T">T Lissitchkov</name></author><author><name sortKey="Stasyshyn, O" uniqKey="Stasyshyn O">O Stasyshyn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Morfini, M" uniqKey="Morfini M">M Morfini</name></author><author><name sortKey="Lee, M" uniqKey="Lee M">M Lee</name></author><author><name sortKey="Messori, A" uniqKey="Messori A">A. 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Roth</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Journeycake, Jm" uniqKey="Journeycake J">JM. Journeycake</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Price, Ve" uniqKey="Price V">VE Price</name></author><author><name sortKey="Carcao, M" uniqKey="Carcao M">M Carcao</name></author><author><name sortKey="Connolly, B" uniqKey="Connolly B">B Connolly</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ranta, S" uniqKey="Ranta S">S Ranta</name></author><author><name sortKey="Kalajoki Helmio, T" uniqKey="Kalajoki Helmio T">T Kalajoki-Helmiö</name></author><author><name sortKey="Pouttu, J" uniqKey="Pouttu J">J Pouttu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Blanchette, Vs" uniqKey="Blanchette V">VS Blanchette</name></author><author><name sortKey="Key, Ns" uniqKey="Key N">NS Key</name></author><author><name sortKey="Ljung, Lr" uniqKey="Ljung L">LR Ljung</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Goodeve, Ac" uniqKey="Goodeve A">AC Goodeve</name></author><author><name sortKey="Reitsma, Ph" uniqKey="Reitsma P">PH Reitsma</name></author><author><name sortKey="Mcvey, Jh" uniqKey="Mcvey J">JH. McVey</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Broderick, Cr" uniqKey="Broderick C">CR Broderick</name></author><author><name sortKey="Herbert, Rd" uniqKey="Herbert R">RD Herbert</name></author><author><name sortKey="Latimer, J" uniqKey="Latimer J">J. Latimer</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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