Dataset Information

Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience.

ABSTRACT: Key objectives in the treatment of multiple sclerosis (MS) include prevention of relapses, a reduction in the accumulation of disability and slowing of the brain volume loss that occurs from the earliest stages of the disease. Teriflunomide, a once-daily, oral immunomodulatory therapy, has demonstrated efficacy across multiple measures of disease activity and worsening in patients with relapsing forms of MS and in those with a first clinical episode suggestive of MS. In this review, the latest evidence relating to the proposed mechanism of action of teriflunomide in MS is explored, including novel insights provided from the recently completed Teri-DYNAMIC study. Key clinical and magnetic resonance imaging data from the completed long-term extensions of the phase II and III (TEMSO, TOWER and TOPIC) studies are highlighted, and the long-term safety profile of teriflunomide, as evidenced by data from these extension studies, is presented. Although randomized clinical trials represent the highest level of evidence to support the use of therapeutic interventions, it is also important to understand the performance of a particular treatment in the real-world setting. In this regard, the results of the recently completed, global, phase IV Teri-PRO study are of particular interest and provide further insights into the benefits of teriflunomide treatment from the patient perspective. Collectively, the data presented in this review demonstrate a favorable benefit-risk profile for teriflunomide, thereby supporting its long-term use for the treatment of patients with relapsing forms of MS.

SUBMITTER: Miller AE

PROVIDER: S-EPMC5703103 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience.

Miller Aaron E AE

Therapeutic advances in neurological disorders 20170913 12

Key objectives in the treatment of multiple sclerosis (MS) include prevention of relapses, a reduction in the accumulation of disability and slowing of the brain volume loss that occurs from the earliest stages of the disease. Teriflunomide, a once-daily, oral immunomodulatory therapy, has demonstrated efficacy across multiple measures of disease activity and worsening in patients with relapsing forms of MS and in those with a first clinical episode suggestive of MS. In this review, the latest e ...[more]

PMID: 29204190

Similar Datasets

Project description:BackgroundDisease-modifying therapy is the standard treatment for patients with multiple sclerosis (MS) in remission. The primary objective of the current analysis was to assess the efficacy and safety of two teriflunomide doses (7 mg and 14 mg) in the subgroup of Chinese patients with relapsing MS included in the TOWER study.MethodsTOWER was a multicenter, multinational, randomized, double-blind, parallel-group (three groups), placebo-controlled study. This subgroup analysis includes 148 Chinese patients randomized to receive either teriflunomide 7 mg (n = 51), teriflunomide 14 mg (n = 43), or placebo (n = 54).ResultsOf the 148 patients in the intent-to-treat population, adjusted annualized relapse rates were 0.63 (95% confidence interval [CI]: 0.44, 0.92) in the placebo group, 0.48 (95% CI: 0.33, 0.70) in the teriflunomide 7 mg group, and 0.18 (95% CI: 0.09, 0.36) in the teriflunomide 14 mg group; this corresponded to a significant relative risk reduction in the teriflunomide 14 mg group versus placebo (-71.2%, P = 0.0012). Teriflunomide 14 mg also tended to reduce 12-week confirmed disability worsening by 68.1% compared with placebo (hazard ratio: 0.319, P = 0.1194). There were no differences across all treatment groups in the proportion of patients with treatment-emergent adverse events (TEAEs; 72.2% in the placebo group, 74.5% in the teriflunomide 7 mg group, and 69.8% in the teriflunomide 14 mg group); corresponding proportions for serious adverse events were 11.1%, 3.9%, and 11.6%, respectively. The most frequently reported TEAEs with teriflunomide versus placebo were neutropenia, increased alanine aminotransferase, and hair thinning.ConclusionsTeriflunomide was as effective and safe in the Chinese subpopulation as it was in the overall population of patients in the TOWER trial. Teriflunomide has the potential to meet unmet medical needs for MS patients in China.Trial registrationClinicalTrials.gov, NCT00751881; https://clinicaltrials.gov/ct2/show/NCT00751881?term=NCT00751881&rank=1.

Dataset Information

Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience.

Publications

Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets