TERIFLUNOMIDE IN EARLY STAGE MS: RESULTS FROM TOPIC. Issue 10 (9th September 2014)

• Record Type: Journal Article
• Authors: Turner, Benjamin; Bauer, Deborah; Benamor, Myriam; Truffinet, Philippe; Miller, Aaron
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 85:Issue 10(2014)
• Page Start: e4
• Page End: e4
• Publication Date: 2014-09-09
• Subjects: EPILEPSY; Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2014-309236.150
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Introduction: Teriflunomide is a once-daily oral immunomodulator approved for relapsing–remitting multiple sclerosis (RRMS). Here we report the efficacy and safety outcomes from the TOPIC trial (NCT00622700 ). Methods: TOPIC was a double-blind, placebo-controlled, parallel-group study in patients with a first clinical episode consistent with MS. Patients were randomised to teriflunomide 14 mg, 7 mg or placebo. The primary endpoint was occurrence of a new clinical relapse, and the key secondary endpoint was occurrence of a new clinical relapse or MRI lesion. Safety and tolerability were also assessed. Results: Baseline characteristics were generally well balanced across groups. Teriflunomide 14mg significantly reduced the risk of a new clinical relapse by 42.6% (p=0.0087) and the risk of a new clinical relapse or MRI lesion by 34.9% (p=0.0003) versus placebo. Teriflunomide 14 mg significantly reduced total lesion volume increase from baseline at every time point and the number of gadolinium-enhancing T1 lesions per scan versus placebo. Safety observations were similar to those of TEMSO and TOWER. Conclusions: Teriflunomide demonstrated efficacy in patients with early stage MS. Together with outcomes from TEMSO and TOWER, these findings support the beneficial effect of teriflunomide across a broad range of patients and disease activity.