Teriflunomide in Patients with Relapsing-Remitting Forms of Multiple Sclerosis.

Chan, Andrew; de Seze, Jérôme; Comabella, Manuel (2016). Teriflunomide in Patients with Relapsing-Remitting Forms of Multiple Sclerosis. CNS drugs, 30(1), pp. 41-51. Springer 10.1007/s40263-015-0299-y

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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.

Item Type:

Journal Article (Review Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DCR Unit Sahli Building > Forschungsgruppe Neurologie
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Chan, Andrew

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1172-7047

Publisher:

Springer

Language:

English

Submitter:

Stefanie Hetzenecker

Date Deposited:

03 May 2017 11:03

Last Modified:

03 May 2017 11:03

Publisher DOI:

10.1007/s40263-015-0299-y

PubMed ID:

26758290

BORIS DOI:

10.7892/boris.94731

URI:

https://boris.unibe.ch/id/eprint/94731

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