A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Identifieur interne : 001161 ( PubMed/Curation ); précédent : 001160; suivant : 001162A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Auteurs : Gérard Socié [France] ; Stéphane Vigouroux [France] ; Ibrahim Yakoub-Agha [France] ; Jacques-Olivier Bay [France] ; Sabine Fürst [France] ; Karin Bilger [France] ; Felipe Suarez [France] ; Mauricette Michallet [France] ; Dominique Bron [Belgique] ; Philippe Gard [France] ; Zakaria Medeghri [France] ; Philippe Lehert [Australie] ; Chinglin Lai [États-Unis] ; Tim Corn ; Jean-Paul Vernant [France]Source :
- Blood [ 1528-0020 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Analyse de survie, Anticorps monoclonaux (effets indésirables), Anticorps monoclonaux (usage thérapeutique), Femelle, Humains, Immunosuppresseurs (effets indésirables), Immunosuppresseurs (usage thérapeutique), Maladie aigüe, Maladie du greffon contre l'hôte (traitement médicamenteux), Modèles de hasards proportionnels, Mâle, Résistance aux substances, Résultat thérapeutique, Stéroïdes (usage thérapeutique), Sérum antilymphocyte (effets indésirables), Sérum antilymphocyte (usage thérapeutique).
- MESH :
- effets indésirables : Anticorps monoclonaux, Immunosuppresseurs, Sérum antilymphocyte.
- traitement médicamenteux : Maladie du greffon contre l'hôte.
- usage thérapeutique : Anticorps monoclonaux, Immunosuppresseurs, Stéroïdes, Sérum antilymphocyte.
- Adulte, Adulte d'âge moyen, Analyse de survie, Femelle, Humains, Maladie aigüe, Modèles de hasards proportionnels, Mâle, Résistance aux substances, Résultat thérapeutique.
English descriptors
- KwdEn :
- Acute Disease, Adult, Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (therapeutic use), Antilymphocyte Serum (adverse effects), Antilymphocyte Serum (therapeutic use), Drug Resistance, Female, Graft vs Host Disease (drug therapy), Humans, Immunosuppressive Agents (adverse effects), Immunosuppressive Agents (therapeutic use), Male, Middle Aged, Proportional Hazards Models, Steroids (therapeutic use), Survival Analysis, Treatment Outcome.
- MESH :
- chemical , adverse effects : Antibodies, Monoclonal, Antilymphocyte Serum, Immunosuppressive Agents.
- chemical , therapeutic use : Antibodies, Monoclonal, Antilymphocyte Serum, Immunosuppressive Agents, Steroids.
- drug therapy : Graft vs Host Disease.
- Acute Disease, Adult, Drug Resistance, Female, Humans, Male, Middle Aged, Proportional Hazards Models, Survival Analysis, Treatment Outcome.
Abstract
Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.
DOI: 10.1182/blood-2016-09-738625
PubMed: 27899357
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Tim Corn<affiliation><nlm:affiliation>Jazz Pharmaceuticals, Oxford, United Kingdom; and.</nlm:affiliation><wicri:noCountry code="subField">United Kingdom; and</wicri:noCountry></affiliation>Le document en format XML
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Institut Jules Bordet (ULB), Bruxelles, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Service d'hématologie, Institut Jules Bordet (ULB), Bruxelles</wicri:regionArea></affiliation></author><author><name sortKey="Gard, Philippe" sort="Gard, Philippe" uniqKey="Gard P" first="Philippe" last="Gard">Philippe Gard</name><affiliation wicri:level="1"><nlm:affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Medeghri, Zakaria" sort="Medeghri, Zakaria" uniqKey="Medeghri Z" first="Zakaria" last="Medeghri">Zakaria Medeghri</name><affiliation wicri:level="1"><nlm:affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</nlm:affiliation><country 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Paris</wicri:regionArea></affiliation></author><author><name sortKey="Vigouroux, Stephane" sort="Vigouroux, Stephane" uniqKey="Vigouroux S" first="Stéphane" last="Vigouroux">Stéphane Vigouroux</name><affiliation wicri:level="1"><nlm:affiliation>Service d'hématologie clinique et thérapie cellulaire, Hôpital Haut-Lévêque, Pessac, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'hématologie clinique et thérapie cellulaire, Hôpital Haut-Lévêque, Pessac</wicri:regionArea></affiliation></author><author><name sortKey="Yakoub Agha, Ibrahim" sort="Yakoub Agha, Ibrahim" uniqKey="Yakoub Agha I" first="Ibrahim" last="Yakoub-Agha">Ibrahim Yakoub-Agha</name><affiliation wicri:level="1"><nlm:affiliation>CHU de Lille, LIRIC INSERM U995, Université Lille2, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>CHU de Lille, LIRIC INSERM U995, Université Lille2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Bay, Jacques Olivier" sort="Bay, Jacques Olivier" uniqKey="Bay J" first="Jacques-Olivier" last="Bay">Jacques-Olivier Bay</name><affiliation wicri:level="1"><nlm:affiliation>Service thérapie cellulaire et hématologie clinique, CHU, Clermont-Ferrand, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service thérapie cellulaire et hématologie clinique, CHU, Clermont-Ferrand</wicri:regionArea></affiliation></author><author><name sortKey="Furst, Sabine" sort="Furst, Sabine" uniqKey="Furst S" first="Sabine" last="Fürst">Sabine Fürst</name><affiliation wicri:level="1"><nlm:affiliation>Unité de Transplantation et de Thérapie Cellulaire, Institut Paoli Calmettes, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Unité de Transplantation et de Thérapie Cellulaire, Institut Paoli Calmettes, Marseille</wicri:regionArea></affiliation></author><author><name sortKey="Bilger, Karin" sort="Bilger, Karin" uniqKey="Bilger K" first="Karin" last="Bilger">Karin Bilger</name><affiliation wicri:level="1"><nlm:affiliation>Service d'Onco-Hématologie, CHU Hautepierre, Strasbourg, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'Onco-Hématologie, CHU Hautepierre, Strasbourg</wicri:regionArea></affiliation></author><author><name sortKey="Suarez, Felipe" sort="Suarez, Felipe" uniqKey="Suarez F" first="Felipe" last="Suarez">Felipe Suarez</name><affiliation wicri:level="1"><nlm:affiliation>Service d'hématologie adulte, Hôpital Necker, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'hématologie adulte, Hôpital Necker, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Michallet, Mauricette" sort="Michallet, Mauricette" uniqKey="Michallet M" first="Mauricette" last="Michallet">Mauricette Michallet</name><affiliation wicri:level="1"><nlm:affiliation>Service d'hématologie, Hôpital Lyon Sud, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'hématologie, Hôpital Lyon Sud, Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name><affiliation wicri:level="1"><nlm:affiliation>Service d'hématologie, Institut Jules Bordet (ULB), Bruxelles, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Service d'hématologie, Institut Jules Bordet (ULB), Bruxelles</wicri:regionArea></affiliation></author><author><name sortKey="Gard, Philippe" sort="Gard, Philippe" uniqKey="Gard P" first="Philippe" last="Gard">Philippe Gard</name><affiliation wicri:level="1"><nlm:affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Medeghri, Zakaria" sort="Medeghri, Zakaria" uniqKey="Medeghri Z" first="Zakaria" last="Medeghri">Zakaria Medeghri</name><affiliation wicri:level="1"><nlm:affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Medicine, University of Melbourne, Melbourne, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Lai, Chinglin" sort="Lai, Chinglin" uniqKey="Lai C" first="Chinglin" last="Lai">Chinglin Lai</name><affiliation wicri:level="2"><nlm:affiliation>Jazz Pharmaceuticals, Palo Alto, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Jazz Pharmaceuticals, Palo Alto</wicri:cityArea></affiliation></author><author><name sortKey="Corn, Tim" sort="Corn, Tim" uniqKey="Corn T" first="Tim" last="Corn">Tim Corn</name><affiliation><nlm:affiliation>Jazz Pharmaceuticals, Oxford, United Kingdom; and.</nlm:affiliation><wicri:noCountry code="subField">United Kingdom; and</wicri:noCountry></affiliation></author><author><name sortKey="Vernant, Jean Paul" sort="Vernant, Jean Paul" uniqKey="Vernant J" first="Jean-Paul" last="Vernant">Jean-Paul Vernant</name><affiliation wicri:level="1"><nlm:affiliation>Service d'hématologie clinique, Hôpital Pitié Salpêtrière, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'hématologie clinique, Hôpital Pitié Salpêtrière, Paris</wicri:regionArea></affiliation></author></analytic><series><title level="j">Blood</title><idno type="eISSN">1528-0020</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute Disease</term><term>Adult</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Antilymphocyte Serum (adverse effects)</term><term>Antilymphocyte Serum (therapeutic use)</term><term>Drug Resistance</term><term>Female</term><term>Graft vs Host Disease (drug therapy)</term><term>Humans</term><term>Immunosuppressive Agents (adverse effects)</term><term>Immunosuppressive Agents (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Proportional Hazards Models</term><term>Steroids (therapeutic use)</term><term>Survival Analysis</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Anticorps monoclonaux (effets indésirables)</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Femelle</term><term>Humains</term><term>Immunosuppresseurs (effets indésirables)</term><term>Immunosuppresseurs (usage thérapeutique)</term><term>Maladie aigüe</term><term>Maladie du greffon contre l'hôte (traitement médicamenteux)</term><term>Modèles de hasards proportionnels</term><term>Mâle</term><term>Résistance aux substances</term><term>Résultat thérapeutique</term><term>Stéroïdes (usage thérapeutique)</term><term>Sérum antilymphocyte (effets indésirables)</term><term>Sérum antilymphocyte (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antilymphocyte Serum</term><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antilymphocyte Serum</term><term>Immunosuppressive Agents</term><term>Steroids</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Graft vs Host Disease</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Immunosuppresseurs</term><term>Sérum antilymphocyte</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Maladie du greffon contre l'hôte</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Immunosuppresseurs</term><term>Stéroïdes</term><term>Sérum antilymphocyte</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Acute Disease</term><term>Adult</term><term>Drug Resistance</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Proportional Hazards Models</term><term>Survival Analysis</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Femelle</term><term>Humains</term><term>Maladie aigüe</term><term>Modèles de hasards proportionnels</term><term>Mâle</term><term>Résistance aux substances</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27899357</PMID><DateCreated><Year>2016</Year><Month>11</Month><Day>30</Day></DateCreated><DateCompleted><Year>2017</Year><Month>08</Month><Day>18</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1528-0020</ISSN><JournalIssue CitedMedium="Internet"><Volume>129</Volume><Issue>5</Issue><PubDate><Year>2017</Year><Month>Feb</Month><Day>02</Day></PubDate></JournalIssue><Title>Blood</Title><ISOAbbreviation>Blood</ISOAbbreviation></Journal><ArticleTitle>A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.</ArticleTitle><Pagination><MedlinePgn>643-649</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1182/blood-2016-09-738625</ELocationID><Abstract><AbstractText>Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.</AbstractText><CopyrightInformation>© 2017 by The American Society of Hematology.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Socié</LastName><ForeName>Gérard</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Service d'Hématologie-Greffe, Assistance Publique-Hôpitaux de Paris, Hôpital St-Louis Lariboisière, Paris, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, Université Paris 7 Denis Diderot, Paris, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>INSERM UMR 1160, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vigouroux</LastName><ForeName>Stéphane</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Service d'hématologie clinique et thérapie cellulaire, Hôpital Haut-Lévêque, Pessac, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yakoub-Agha</LastName><ForeName>Ibrahim</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>CHU de Lille, LIRIC INSERM U995, Université Lille2, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bay</LastName><ForeName>Jacques-Olivier</ForeName><Initials>JO</Initials><AffiliationInfo><Affiliation>Service thérapie cellulaire et hématologie clinique, CHU, Clermont-Ferrand, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fürst</LastName><ForeName>Sabine</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Unité de Transplantation et de Thérapie Cellulaire, Institut Paoli Calmettes, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bilger</LastName><ForeName>Karin</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Service d'Onco-Hématologie, CHU Hautepierre, Strasbourg, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suarez</LastName><ForeName>Felipe</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Service d'hématologie adulte, Hôpital Necker, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Michallet</LastName><ForeName>Mauricette</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Service d'hématologie, Hôpital Lyon Sud, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bron</LastName><ForeName>Dominique</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Service d'hématologie, Institut Jules Bordet (ULB), Bruxelles, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gard</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Medeghri</LastName><ForeName>Zakaria</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>EUSA Pharma (Europe) Limited (a Jazz Pharmaceuticals company), Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lehert</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lai</LastName><ForeName>Chinglin</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Jazz Pharmaceuticals, Palo Alto, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Corn</LastName><ForeName>Tim</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Jazz Pharmaceuticals, Oxford, United Kingdom; and.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vernant</LastName><ForeName>Jean-Paul</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>Service d'hématologie clinique, Hôpital Pitié Salpêtrière, Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>11</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Blood</MedlineTA><NlmUniqueID>7603509</NlmUniqueID><ISSNLinking>0006-4971</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000961">Antilymphocyte Serum</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013256">Steroids</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C079843">inolimomab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000208" MajorTopicYN="N">Acute Disease</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000961" MajorTopicYN="N">Antilymphocyte Serum</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004351" MajorTopicYN="N">Drug Resistance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006086" MajorTopicYN="N">Graft vs Host Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007166" MajorTopicYN="N">Immunosuppressive Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013256" MajorTopicYN="N">Steroids</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016019" MajorTopicYN="N">Survival Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>09</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>11</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>12</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27899357</ArticleId><ArticleId IdType="pii">blood-2016-09-738625</ArticleId><ArticleId IdType="doi">10.1182/blood-2016-09-738625</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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