TECFIDERA Efficacy Was Sustained Over 5 Years in an
Extension Study1


ENDORSE Extension Study Design

  • A multicenter, randomized, dose-comparison, extension study of RRMS patients who completed the 2-year DEFINE or CONFIRM study and enrolled in ENDORSE
  • Patients had a minimum follow-up of 3 years in ENDORSE in this report
  • 501 patients in the intention-to-treat (ITT) population received continuous TECFIDERA treatment (240 mg BID), and 249 patients (ITT) received delayed TECFIDERA treatment (2 years placebo followed by 3 years TECFIDERA 240 mg BID)
  • Primary objective: to evaluate the long-term safety of TECFIDERA
  • Two secondary objectives: ARR and disability progression

Limitations and Disclosures

  • These are interim data of an ongoing study and results are subject to change until the study is completed
  • Complete study design and results are not presented
  • Bias could result because not all patients randomized in the DEFINE or CONFIRM study were enrolled and dosed in ENDORSE
  • No sample size was calculated for ENDORSE


ARR by yearly interval

Continuous TECFIDERA Treatment vs Delayed TECFIDERA Treatment
Continuous TECFIDERA Treatment vs Delayed TECFIDERA Treatment

Adapted with permission from SAGE Publications, Inc.

 


Disability progression estimated after 5 years

Continuous TECFIDERA
Treatment

18.6%

of patients had confirmed EDSS progression sustained over 24 weeks (95% CI: 15.3%–22.4%)

Delayed TECFIDERA
Treatment

21.1%

of patients had confirmed EDSS progression sustained over 24 weeks (95% CI: 16.2%–27.1%)

Safety in ENDORSE1

  • Incidence of adverse events (AEs), serious adverse events, and discontinuations was similar among the continuous and delayed treatment groups
  • A higher proportion of patients in the delayed treatment group discontinued due to AEs, primarily flushing and gastrointestinal events

 

ENDORSE=A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis2; RRMS=relapsing-remitting multiple sclerosis; DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS3; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis4; ITT=intention-to-treat; BID=twice-daily; PBO=placebo; EDSS=Expanded Disability Status Scale; CI=confidence interval.

 

References: 1. Gold R, et al. Mult Scler. 2017;23(2):253-265. 2. BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT00835770. Accessed April 22, 2019. 3. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107. Erratum in: N Engl J Med. 2012;367(24):2362. 4. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097. Erratum in: N Engl J Med. 2012;367(17):1673.