Single-arm study to assess comprehensive infusion guidance for the prevention and management of the infusion associated reactions (IARs) in relapsing-remitting multiple sclerosis (RRMS) patients treated with alemtuzumab (EMERALD).
Fiche publication
Date publication
janvier 2019
Journal
Multiple sclerosis and related disorders
Auteurs
Membres identifiés du Cancéropôle Est :
Pr DE SEZE Jérôme
Tous les auteurs :
Vukusic S, Brassat D, de Seze J, Izquierdo G, Lysandropoulos A, Moll W, Vanopdenbosch L, Arque MJ, Kertous M, Rufi P, Oreja-Guevara C
Lien Pubmed
Résumé
Alemtuzumab is a humanized IgG monoclonal antibody approved in more than 60 countries for patients with relapsing remitting multiple sclerosis (RRMS). In phase 2 and 3 clinical trials (CAMMS223 (NCT00050778), CARE-MS I (NCT00530348), and CARE-MS II (NCT00548405)), patients receiving alemtuzumab demonstrated significantly greater improvements on clinical and MRI outcomes versus SC IFNβ-1a; mild to moderate infusion-associated reactions (IARs) were the most frequently reported adverse events (AEs) associated with alemtuzumab. EMERALD (NCT02205489) was a phase 4, multicenter, multinational, single-arm study designed to assess an algorithm for the prevention and management of IARs in RRMS patients treated with alemtuzumab.
Mots clés
Alemtuzumab, Induction therapy, Infusion-associated reaction (IAR), Methylprednisolone treatment, Multiple sclerosis, Rash
Référence
Mult Scler Relat Disord. 2019 Jan 6;29:7-14