A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Identifieur interne : 001274 ( Main/Exploration ); précédent : 001273; suivant : 001275A 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
Affiliations:
- Australie, Belgique, France, États-Unis
- Alsace (région administrative), Auvergne (région administrative), Auvergne-Rhône-Alpes, Californie, Grand Est, Hauts-de-France, Nord-Pas-de-Calais, Provence-Alpes-Côte d'Azur, Rhône-Alpes, Région de Bruxelles-Capitale, Victoria (État), Île-de-France
- Bruxelles, Clermont-Ferrand, Lille, Lyon, Marseille, Melbourne, Paris, Strasbourg
- Université de Melbourne
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Le document en format XML
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steroid-resistant acute GVHD.</title><author><name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gérard" last="Socié">Gérard Socié</name><affiliation wicri:level="3"><nlm:affiliation>Service d'Hématologie-Greffe, Assistance Publique-Hôpitaux de Paris, Hôpital St-Louis Lariboisière, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'Hématologie-Greffe, Assistance Publique-Hôpitaux de Paris, Hôpital St-Louis Lariboisière, 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="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><wicri:noRegion>Pessac</wicri:noRegion><wicri:noRegion>Pessac</wicri:noRegion></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="3"><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><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></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="3"><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><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Auvergne (région administrative)</region><settlement type="city">Clermont-Ferrand</settlement></placeName></affiliation></author><author><name sortKey="Furst, Sabine" sort="Furst, Sabine" uniqKey="Furst S" first="Sabine" last="Fürst">Sabine Fürst</name><affiliation wicri:level="3"><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><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Bilger, Karin" sort="Bilger, Karin" uniqKey="Bilger K" first="Karin" last="Bilger">Karin Bilger</name><affiliation wicri:level="3"><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><placeName><region type="region">Grand Est</region><region type="old region">Alsace (région administrative)</region><settlement type="city">Strasbourg</settlement></placeName></affiliation></author><author><name sortKey="Suarez, Felipe" sort="Suarez, Felipe" uniqKey="Suarez F" first="Felipe" last="Suarez">Felipe Suarez</name><affiliation wicri:level="3"><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><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="Michallet, Mauricette" sort="Michallet, Mauricette" uniqKey="Michallet M" first="Mauricette" last="Michallet">Mauricette Michallet</name><affiliation wicri:level="3"><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><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Gard, Philippe" sort="Gard, Philippe" uniqKey="Gard P" first="Philippe" last="Gard">Philippe Gard</name><affiliation wicri:level="3"><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><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Medeghri, Zakaria" sort="Medeghri, Zakaria" uniqKey="Medeghri Z" first="Zakaria" last="Medeghri">Zakaria Medeghri</name><affiliation wicri:level="3"><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><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name><affiliation wicri:level="4"><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><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></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="3"><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><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></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><affiliations><list><country><li>Australie</li><li>Belgique</li><li>France</li><li>États-Unis</li></country><region><li>Alsace (région administrative)</li><li>Auvergne (région administrative)</li><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Grand Est</li><li>Hauts-de-France</li><li>Nord-Pas-de-Calais</li><li>Provence-Alpes-Côte d'Azur</li><li>Rhône-Alpes</li><li>Région de Bruxelles-Capitale</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Bruxelles</li><li>Clermont-Ferrand</li><li>Lille</li><li>Lyon</li><li>Marseille</li><li>Melbourne</li><li>Paris</li><li>Strasbourg</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><noCountry><name sortKey="Corn, Tim" sort="Corn, Tim" uniqKey="Corn T" first="Tim" last="Corn">Tim Corn</name></noCountry><country name="France"><region name="Île-de-France"><name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gérard" last="Socié">Gérard Socié</name></region><name sortKey="Bay, Jacques Olivier" sort="Bay, Jacques Olivier" uniqKey="Bay J" first="Jacques-Olivier" last="Bay">Jacques-Olivier Bay</name><name sortKey="Bilger, Karin" sort="Bilger, Karin" uniqKey="Bilger K" first="Karin" last="Bilger">Karin Bilger</name><name sortKey="Furst, Sabine" sort="Furst, Sabine" uniqKey="Furst S" first="Sabine" last="Fürst">Sabine Fürst</name><name sortKey="Gard, Philippe" sort="Gard, Philippe" uniqKey="Gard P" first="Philippe" last="Gard">Philippe Gard</name><name sortKey="Medeghri, Zakaria" sort="Medeghri, Zakaria" uniqKey="Medeghri Z" first="Zakaria" last="Medeghri">Zakaria Medeghri</name><name sortKey="Michallet, Mauricette" sort="Michallet, Mauricette" uniqKey="Michallet M" first="Mauricette" last="Michallet">Mauricette Michallet</name><name sortKey="Suarez, Felipe" sort="Suarez, Felipe" uniqKey="Suarez F" first="Felipe" last="Suarez">Felipe Suarez</name><name sortKey="Vernant, Jean Paul" sort="Vernant, Jean Paul" uniqKey="Vernant J" first="Jean-Paul" last="Vernant">Jean-Paul Vernant</name><name sortKey="Vigouroux, Stephane" sort="Vigouroux, Stephane" uniqKey="Vigouroux S" first="Stéphane" last="Vigouroux">Stéphane Vigouroux</name><name sortKey="Yakoub Agha, Ibrahim" sort="Yakoub Agha, Ibrahim" uniqKey="Yakoub Agha I" first="Ibrahim" last="Yakoub-Agha">Ibrahim Yakoub-Agha</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name></region></country><country name="États-Unis"><region name="Californie"><name sortKey="Lai, Chinglin" sort="Lai, Chinglin" uniqKey="Lai C" first="Chinglin" last="Lai">Chinglin Lai</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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