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

Mark S Freedman; Julia Morawski; Karthinathan Thangavelu

doi:10.1177/2055217318775236

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

Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

Authors

Mark S Freedman¹, Julia Morawski², Karthinathan Thangavelu³

Affiliations

¹ Multiple Sclerosis Research Clinic, University of Ottawa and the Ottawa Hospital Research Institute, Canada.
² MS Global Health Economics and Value Assessment, Sanofi, USA.
³ Biostatistics, Sanofi, USA.

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.

Associated data

ClinicalTrials.gov/NCT00751881