A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Identifieur interne : 001164 ( PubMed/Corpus ); précédent : 001163; suivant : 001165A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Auteurs : Gérard Socié ; Stéphane Vigouroux ; Ibrahim Yakoub-Agha ; Jacques-Olivier Bay ; Sabine Fürst ; Karin Bilger ; Felipe Suarez ; Mauricette Michallet ; Dominique Bron ; Philippe Gard ; Zakaria Medeghri ; Philippe Lehert ; Chinglin Lai ; Tim Corn ; Jean-Paul VernantSource :
- Blood [ 1528-0020 ] ; 2017.
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
Links to Exploration step
pubmed:27899357Le document en format XML
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<term>Antilymphocyte Serum (therapeutic use)</term>
<term>Drug Resistance</term>
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<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>
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<Month>11</Month>
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<ArticleTitle>A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.</ArticleTitle>
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<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>
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<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>
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<ForeName>Stéphane</ForeName>
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</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>
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<Author ValidYN="Y"><LastName>Bay</LastName>
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</AffiliationInfo>
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<ForeName>Sabine</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Unité de Transplantation et de Thérapie Cellulaire, Institut Paoli Calmettes, Marseille, France.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Bilger</LastName>
<ForeName>Karin</ForeName>
<Initials>K</Initials>
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</AffiliationInfo>
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</AffiliationInfo>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Bron</LastName>
<ForeName>Dominique</ForeName>
<Initials>D</Initials>
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</AffiliationInfo>
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<ForeName>Philippe</ForeName>
<Initials>P</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Medeghri</LastName>
<ForeName>Zakaria</ForeName>
<Initials>Z</Initials>
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</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Chinglin</ForeName>
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</AffiliationInfo>
</Author>
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<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>
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<Month>11</Month>
<Day>29</Day>
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<MedlineTA>Blood</MedlineTA>
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<ISSNLinking>0006-4971</ISSNLinking>
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<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000961">Antilymphocyte Serum</NameOfSubstance>
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