Fiche publication
Date publication
janvier 2016
Journal
CNS drugs
Auteurs
Membres identifiés du Cancéropôle Est :
Pr DE SEZE Jérôme
Tous les auteurs :
Chan A, de Seze J, Comabella M
Lien Pubmed
Résumé
Teriflunomide is a once-daily oral agent that has been licensed in the EU since August 2013 for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). More recently (September 2014), the EU summary of product characteristics (SmPC) was updated to include data from patients with a first clinical demyelinating event. This review examines the EU SmPC for teriflunomide, with reference to key clinical and safety outcomes and practical considerations for prescribing physicians. In two phase III trials (TEMSO and TOWER) in patients with relapsing forms of MS, teriflunomide 14 mg significantly reduced the annualized relapse rate and the risk of confirmed disability progression sustained for at least 12 weeks. Magnetic resonance imaging (MRI) total lesion volume, gadolinium-enhancing lesions, and unique active lesions were reduced with teriflunomide treatment in TEMSO. In the TOPIC study, in patients with a first clinical demyelinating event, teriflunomide treatment significantly reduced the time to a second clinical episode (relapse). Across the clinical studies, teriflunomide was generally well tolerated; adverse events reported in ≥ 10% of teriflunomide-treated patients were diarrhea, nausea, increased alanine aminotransferase, and alopecia. Data from the clinical development program support the use of teriflunomide in a broad spectrum of patients with RRMS.
Mots clés
Administration, Oral, Clinical Trials, Phase III as Topic, Crotonates, administration & dosage, Drug Administration Schedule, Humans, Multiple Sclerosis, Relapsing-Remitting, drug therapy, Randomized Controlled Trials as Topic, Toluidines, administration & dosage, Treatment Outcome
Référence
CNS Drugs. 2016 Jan;30(1):41-51
