Long-term outcomes with teriflunomide in patients with clinically isolated syndrome: Results of the TOPIC extension study^★★

Highlights

• We assessed the efficacy/safety of teriflunomide (TFM) extended treatment in TOPIC.

• Early TFM 14 mg treatment reduced CDMS conversion risk by 47.1% vs delayed treatment.

• Low MRI activity was maintained in the extension with early TFM treatment.

• No new safety signals were seen with TFM extended treatment.

• Results support the importance of early/continuous treatment on the disease course.

Abstract

Background

In the phase 3 TOPIC study, teriflunomide significantly reduced the risk of relapse determining conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome, versus placebo. We assessed clinical and safety outcomes associated with extended teriflunomide treatment in the TOPIC extension study.

Methods

Patients who completed the TOPIC core study (including those still on study at early termination) or converted to CDMS after at least 24 weeks in the core study were eligible to participate in the extension. The primary efficacy endpoint in the extension was time to conversion to CDMS.

Results

Risk of relapse determining conversion to CDMS was 47.1% lower in patients treated with teriflunomide 14 mg during the core and extension studies compared with patients treated with placebo during the core study and teriflunomide 14 mg during the extension. The incidence of adverse events was 75.8% and 81.9% for 7 and 14 mg teriflunomide, respectively.

Conclusions

Reduced risk of relapse determining conversion to CDMS in patients with early MS receiving teriflunomide 14 mg in the core study remained throughout the extension supporting the benefits of early treatment. No new safety signals were observed for teriflunomide 7 or 14 mg.