Study 1 included 1234 patients with RRMS randomized to receive Tecfidera 240 mg twice a day (n=410), Tecfidera 240 mg three times a day (n=416), or placebo (n=408) for up to 2 years with 69%, 69%, and 65% completing the study, respectively.  In a subgroup of patients tested by MRI at various points in time throughout the study, 45% experienced no new or newly enlarging lesions.  In patients taking Tecfidera twice daily, only 27% experienced relapses, representing a 49% relative risk reduction rate, and 84% experienced no disability progression, representing a 38% relative risk reduction.  

In Study 2, patients were randomized to receive Tecfidera 240 mg twice a day (n=359), Tecfidera 240 mg three times a day (n=345), an open-label comparator (n=350), or placebo (n=363) for up to 2 years with 64-72% of participants completing the study.  In Study 2, Tecfidera had a positive statistically significant effect on relapse rate and number of new and/or enlarging lesions as seen on MRI.  In patients taking Tecfidera twice daily, annualized relapse rate at two years was reduced by 44%.  Although there was no statistically significant effect on disability progression in Study 2, only 13% of patients taking the twice daily dose experienced confirmed disability progress as measured by at least a 1 point increase in EDSS score which was sustained for 12 weeks.

What do you think about Tecfidera?

At my recent visit at the neurology clinic, I asked for opinions on Tecfidera.  My nurse practitioner expressed that patients and neurologists have been anxiously awaiting the approval of Tecfidera (BG12).  They are excited about the safety profile, efficacy, and ease of administration.  My nurse expressed that she would not be surprised if Tecfidera became one of the first go-to treatments for newly diagnosed patients.

What do you think about the arrival of Tecfidera?  Do you plan to stick with your current treatment or do you think you might consider switching drugs?

SOURCES:

Tecfidera, full prescribing information, accessed at http://tecfidera.com/tecfidera-prescribing-information.html

FDA announcement regarding approval of Tecfidera accessed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm

Lisa Emrich is author of the blog Brass and Ivory: Life with MS and RA and founder of the Carnival of MS Bloggers.