Braune, et al 2018 Study Design and Methodology:
Relapse rate based on TTFR was lower in the TECFIDERA population vs the interferons, Copaxone, and Aubagio populations, and similar to Gilenya populations
TECFIDERA had a lower ARR vs the interferons, Copaxone, and Aubagio populations, and a similar ARR to Gilenya
*PSM is a method that helps reduce the impact of confounding and selection/indication biases to better balance the distributions of covariates across treatment groups, approximating a randomized study design.
†Covariates in this study included age, gender, disease duration, treatment history, baseline EDSS score, and total number of relapses in the past 12 and 24 months.
‡Pairwise data are not shown, but can be found in the Braune study manuscript.
§All relapse results from the non-pairwise censored analysis were confirmed by the pairwise censoring relapse results.
Results of the analysis comparing TECFIDERA to Gilenya showed no evidence of a difference in time to first relapse (TTFR) in the all-comer population. TTFR was also similar in patients meeting the EU label criteria for Gilenya and who had failed prior therapy with interferons, Copaxone, or Aubagio with an on-therapy relapse in the last 12 months and a treatment gap of up to 6 months.
Adapted with permission of the authors.