Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study

Mark S Freedman, Julia Morawski, Karthinathan Thangavelu, Mark S Freedman, Julia Morawski, Karthinathan Thangavelu

Abstract

Patients enrolled in the phase 3 TOWER study (NCT00751881) of teriflunomide had variable treatment durations (48-173 weeks). This has led to challenges when interpreting results in the context of other phase 3 trials of disease-modifying therapies for multiple sclerosis, which typically have a fixed 2-year duration. This communication reports clinical outcomes in TOWER over a fixed 2-year period. Reductions in annualised relapse rates and 12-week confirmed disability worsening associated with teriflunomide were comparable between overall intent-to-treat and fixed 2-year study populations in TOWER. Consistency in outcomes supports the inclusion of TOWER data in comparative analyses with other disease-modifying therapies. ClinicalTrials.gov: NCT00751881.

Keywords: Teriflunomide; clinical trial; disease-modifying therapy; multiple sclerosis; outcomes assessment; phase 3.

Figures

Figure 1.
Figure 1.
Efficacy results in the overall intent-to-treat (ITT) and 2-year study populations. aThe overall ITT population includes all patients randomly assigned to placebo or teriflunomide 14 mg in the core TOWER study, who received at least one dose of study drug. bThe 2-year study population includes patients treated for 96 weeks relative to individual randomisation dates and is extracted from the TOWER ITT population; the same statistical analysis was used as for the overall ITT population. cObserved number of patients (%) with 12-week confirmed disability worsening in placebo versus teriflunomide 14 mg groups: in ITT population, 65/388 (16.8%) versus 44/370 (11.9%); in 2-year study population, 42/228 (18.4%) versus 26/223 (11.7%). The 12-week confirmation of disability worsening should have occurred within the 2-year study period. ARR: annualised relapse rate; CI: confidence interval; RR: relative risk; RRR: relative risk reduction.

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Source: PubMed

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