A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.
Fiche publication
Date publication
février 2017
Journal
Blood
Auteurs
Membres identifiés du Cancéropôle Est :
Dr BILGER Karin
Tous les auteurs :
Socié G, Vigouroux S, Yakoub-Agha I, Bay JO, Fürst S, Bilger K, Suarez F, Michallet M, Bron D, Gard P, Medeghri Z, Lehert P, Lai C, Corn T, Vernant JP
Lien Pubmed
Résumé
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.
Mots clés
Acute Disease, Adult, Antibodies, Monoclonal, adverse effects, Antilymphocyte Serum, adverse effects, Drug Resistance, Female, Graft vs Host Disease, drug therapy, Humans, Immunosuppressive Agents, adverse effects, Male, Middle Aged, Proportional Hazards Models, Steroids, therapeutic use, Survival Analysis, Treatment Outcome
Référence
Blood. 2017 Feb;129(5):643-649