Long-term safety and efficacy of sustained eculizumab treatment in patients with paroxysmal nocturnal haemoglobinuria
Identifieur interne : 004E31 ( Main/Exploration ); précédent : 004E30; suivant : 004E32Long-term safety and efficacy of sustained eculizumab treatment in patients with paroxysmal nocturnal haemoglobinuria
Auteurs : Peter Hillmen [Royaume-Uni] ; Petra Muus [Pays-Bas] ; Alexander Röth [Allemagne] ; Modupe O. Elebute [Royaume-Uni] ; Antonio M. Risitano [Italie] ; Hubert Schrezenmeier [Allemagne] ; Jeffrey Szer [Australie] ; Paul Browne [Irlande (pays)] ; Jaroslaw P. Maciejewski [États-Unis] ; Jörg Schubert [Allemagne] ; Alvaro Urbano-Ispizua [Espagne] ; Carlos De Castro [États-Unis] ; Gérard Socie [France] ; Robert A. Brodsky [États-Unis]Source :
- British journal of haematology [ 0007-1048 ] ; 2013.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Paroxysmal nocturnal haemoglobinuria (PNH) is characterized by chronic, uncontrolled complement activation resulting in elevated intravascular haemolysis and morbidities, including fatigue, dyspnoea, abdominal pain, pulmonary hypertension, thrombotic events (TEs) and chronic kidney disease (CKD). The long-term safety and efficacy of eculizumab, a humanized monoclonal antibody that inhibits terminal complement activation, was investigated in 195 patients over 66 months. Four patient deaths were reported, all unrelated to treatment, resulting in a 3-year survival estimate of 97.6%. All patients showed a reduction in lactate dehydrogenase levels, which was sustained over the course of treatment (median reduction of 86.9% at 36 months), reflecting inhibition of chronic haemolysis. TEs decreased by 81.8%, with 96.4% of patients remaining free of TEs. Patients also showed a time-dependent improvement in renal function: 93.1% of patients exhibited improvement or stabilization in CKD score at 36 months. Transfusion independence increased by 90.0% from baseline, with the number of red blood cell units transfused decreasing by 54.7%. Eculizumab was well tolerated, with no evidence of cumulative toxicity and a decreasing occurrence of adverse events over time. Eculizumab has a substantial impact on the symptoms and complications of PNH and results a significant improvement in patient survival.
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Affiliations:
- Allemagne, Australie, Espagne, France, Irlande (pays), Italie, Pays-Bas, Royaume-Uni, États-Unis
- Angleterre, Bade-Wurtemberg, Catalogne, District de Tübingen, Grand Londres, Gueldre, Victoria (État), Île-de-France
- Barcelone, Londres, Melbourne, Nimègue, Paris, Ulm
- Université d'Ulm
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Elebute</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Haematological Medicine, King's College Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Risitano, Antonio M" sort="Risitano, Antonio M" uniqKey="Risitano A" first="Antonio M." last="Risitano">Antonio M. Risitano</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Federico II University</s1><s2>Naples</s2><s3>ITA</s3><sZ>5 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Federico II University</wicri:noRegion></affiliation></author><author><name sortKey="Schrezenmeier, Hubert" sort="Schrezenmeier, Hubert" uniqKey="Schrezenmeier H" first="Hubert" last="Schrezenmeier">Hubert Schrezenmeier</name><affiliation wicri:level="4"><inist:fA14 i1="06"><s1>Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and Institute of Transfusion Medicine, University of Ulm</s1><s2>Ulm</s2><s3>DEU</s3><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement><settlement type="city">Ulm</settlement></placeName><orgName type="university">Université d'Ulm</orgName></affiliation></author><author><name sortKey="Szer, Jeffrey" sort="Szer, Jeffrey" uniqKey="Szer J" first="Jeffrey" last="Szer">Jeffrey Szer</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Royal Melbourne Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Browne, Paul" sort="Browne, Paul" uniqKey="Browne P" first="Paul" last="Browne">Paul Browne</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>St. James's Hospital, Trinity College Dublin</s1><s2>Dublin</s2><s3>IRL</s3><sZ>8 aut.</sZ></inist:fA14><country>Irlande (pays)</country><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Maciejewski, Jaroslaw P" sort="Maciejewski, Jaroslaw P" uniqKey="Maciejewski J" first="Jaroslaw P." last="Maciejewski">Jaroslaw P. Maciejewski</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Taussig Cancer Center, Cleveland Clinic</s1><s2>Cleveland, OH</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Cleveland, OH</wicri:noRegion></affiliation></author><author><name sortKey="Schubert, Jorg" sort="Schubert, Jorg" uniqKey="Schubert J" first="Jörg" last="Schubert">Jörg Schubert</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Saarland University Medical School</s1><s2>Homburg-Saarland</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Homburg-Saarland</wicri:noRegion><wicri:noRegion>Saarland University Medical School</wicri:noRegion><wicri:noRegion>Saarland University Medical School</wicri:noRegion></affiliation></author><author><name sortKey="Urbano Ispizua, Alvaro" sort="Urbano Ispizua, Alvaro" uniqKey="Urbano Ispizua A" first="Alvaro" last="Urbano-Ispizua">Alvaro Urbano-Ispizua</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Grupo de Trabajo de HPN de la Sociedad Española de Hematologia y Hemoterapia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="De Castro, Carlos" sort="De Castro, Carlos" uniqKey="De Castro C" first="Carlos" last="De Castro">Carlos De Castro</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Duke University Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gérard" last="Socie">Gérard Socie</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Hôpital Saint-Louis and Institut National de la Santé et de la Recherche Médicale (INSERM)</s1><s2>Paris</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><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="Brodsky, Robert A" sort="Brodsky, Robert A" uniqKey="Brodsky R" first="Robert A." last="Brodsky">Robert A. Brodsky</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Johns Hopkins University School of Medicine</s1><s2>Baltimore, MD</s2><s3>USA</s3><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Johns Hopkins University School of Medicine</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">British journal of haematology</title><title level="j" type="abbreviated">Br. j. haematol.</title><idno type="ISSN">0007-1048</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of haematology</title><title level="j" type="abbreviated">Br. j. haematol.</title><idno type="ISSN">0007-1048</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cancerology</term><term>Eculizumab</term><term>Hematology</term><term>Hemolysis</term><term>Human</term><term>Long term</term><term>Nocturnal paroxystic anemia</term><term>Treatment</term><term>Treatment efficiency</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Eculizumab</term><term>Long terme</term><term>Efficacité traitement</term><term>Anémie hémolytique de Marchiafava-Micheli</term><term>Traitement</term><term>Homme</term><term>Hémolyse</term><term>Cancérologie</term><term>Hématologie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Paroxysmal nocturnal haemoglobinuria (PNH) is characterized by chronic, uncontrolled complement activation resulting in elevated intravascular haemolysis and morbidities, including fatigue, dyspnoea, abdominal pain, pulmonary hypertension, thrombotic events (TEs) and chronic kidney disease (CKD). The long-term safety and efficacy of eculizumab, a humanized monoclonal antibody that inhibits terminal complement activation, was investigated in 195 patients over 66 months. Four patient deaths were reported, all unrelated to treatment, resulting in a 3-year survival estimate of 97.6%. All patients showed a reduction in lactate dehydrogenase levels, which was sustained over the course of treatment (median reduction of 86.9% at 36 months), reflecting inhibition of chronic haemolysis. TEs decreased by 81.8%, with 96.4% of patients remaining free of TEs. Patients also showed a time-dependent improvement in renal function: 93.1% of patients exhibited improvement or stabilization in CKD score at 36 months. Transfusion independence increased by 90.0% from baseline, with the number of red blood cell units transfused decreasing by 54.7%. Eculizumab was well tolerated, with no evidence of cumulative toxicity and a decreasing occurrence of adverse events over time. Eculizumab has a substantial impact on the symptoms and complications of PNH and results a significant improvement in patient survival.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Espagne</li><li>France</li><li>Irlande (pays)</li><li>Italie</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>Catalogne</li><li>District de Tübingen</li><li>Grand Londres</li><li>Gueldre</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Barcelone</li><li>Londres</li><li>Melbourne</li><li>Nimègue</li><li>Paris</li><li>Ulm</li></settlement><orgName><li>Université d'Ulm</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name></noRegion><name sortKey="Elebute, Modupe O" sort="Elebute, Modupe O" uniqKey="Elebute M" first="Modupe O." last="Elebute">Modupe O. Elebute</name></country><country name="Pays-Bas"><region name="Gueldre"><name sortKey="Muus, Petra" sort="Muus, Petra" uniqKey="Muus P" first="Petra" last="Muus">Petra Muus</name></region></country><country name="Allemagne"><noRegion><name sortKey="Roth, Alexander" sort="Roth, Alexander" uniqKey="Roth A" first="Alexander" last="Röth">Alexander Röth</name></noRegion><name sortKey="Schrezenmeier, Hubert" sort="Schrezenmeier, Hubert" uniqKey="Schrezenmeier H" first="Hubert" last="Schrezenmeier">Hubert Schrezenmeier</name><name sortKey="Schubert, Jorg" sort="Schubert, Jorg" uniqKey="Schubert J" first="Jörg" last="Schubert">Jörg Schubert</name></country><country name="Italie"><noRegion><name sortKey="Risitano, Antonio M" sort="Risitano, Antonio M" uniqKey="Risitano A" first="Antonio M." last="Risitano">Antonio M. Risitano</name></noRegion></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Szer, Jeffrey" sort="Szer, Jeffrey" uniqKey="Szer J" first="Jeffrey" last="Szer">Jeffrey Szer</name></region></country><country name="Irlande (pays)"><noRegion><name sortKey="Browne, Paul" sort="Browne, Paul" uniqKey="Browne P" first="Paul" last="Browne">Paul Browne</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Maciejewski, Jaroslaw P" sort="Maciejewski, Jaroslaw P" uniqKey="Maciejewski J" first="Jaroslaw P." last="Maciejewski">Jaroslaw P. Maciejewski</name></noRegion><name sortKey="Brodsky, Robert A" sort="Brodsky, Robert A" uniqKey="Brodsky R" first="Robert A." last="Brodsky">Robert A. Brodsky</name><name sortKey="De Castro, Carlos" sort="De Castro, Carlos" uniqKey="De Castro C" first="Carlos" last="De Castro">Carlos De Castro</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Urbano Ispizua, Alvaro" sort="Urbano Ispizua, Alvaro" uniqKey="Urbano Ispizua A" first="Alvaro" last="Urbano-Ispizua">Alvaro Urbano-Ispizua</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gérard" last="Socie">Gérard Socie</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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