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

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...

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Detalles Bibliográficos
Autores principales: Freedman, Mark S, Morawski, Julia, Thangavelu, Karthinathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5960864/
https://www.ncbi.nlm.nih.gov/pubmed/29796289
http://dx.doi.org/10.1177/2055217318775236
Descripción
Sumario: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.