The FINANCIAL — Biogen on April 20 announced new data that continue to support TECFIDERA (dimethyl fumarate) as an effective, long-term treatment for people who are living with relapsing forms of multiple sclerosis (MS).
Data show TECFIDERA significantly reduced relapses and disability progression in newly-diagnosed relapsing-remitting MS (RRMS) patients who had highly active disease. Additional data indicate TECFIDERA showed strong and sustained efficacy over five years in RRMS patients who were previously treated with an interferon (interferon beta-1a/b [IFN]) or glatiramer acetate (GA). These results will be presented at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C., according to Biogen.
“Taken together, these studies reinforce that TECFIDERA delivers robust efficacy when used as a first-line therapy, as well as when it is used after a patient has discontinued interferon or glatiramer acetate treatment,” said J. Theodore Phillips, M.D., Ph.D., research investigator at the Baylor Institute for Immunology Research and clinical professor of Neurology at the University of Texas Southwestern Medical Center. “In addition, strong efficacy was observed with TECFIDERA treatment in various patient populations including those with highly active MS.”
Robust Efficacy in Newly-Diagnosed Patients with Highly Active MS
TECFIDERA provided robust efficacy in newly-diagnosed patients who have highly active MS, as seen in a post-hoc analysis of two years of integrated data from the Phase 3 DEFINE and CONFIRM studies. Patients included in the analysis were diagnosed with RRMS within one year prior to enrolling in the DEFINE or CONFIRM studies, were either treatment-naïve or previously treated with corticosteroids alone, and met the criteria for highly active MS (two or more relapses within one year prior to enrolling in DEFINE or CONFIRM). Compared to placebo (n=77) at two years, TECFIDERA (n=84) significantly reduced annualized relapse rate (ARR) (56% reduction, p<0.0040), the proportion of patients who relapsed (56% reduction, p=0.0037) and time to sustained 12-week progression of disability (78% reduction, p=0.0067).
“TECFIDERA continues to demonstrate consistently strong efficacy and favorable safety results that we believe support its position as the new oral standard of care,” said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen. “More than 135,000 patients have been treated with TECFIDERA worldwide since it was introduced to the market two years ago.”
Long-Term Efficacy of TECFIDERA in Treatment-Naïve Patients and Those with Prior IFN/GA Treatment Experience
TECFIDERA provided consistent, long-term efficacy in patients with RRMS who were previously treated with IFN or GA, according to an integrated post-hoc analysis in a subset of patients from the Phase 3 DEFINE, CONFIRM and ENDORSE studies. Patients included in the analysis were followed for a minimum of five years (two years in DEFINE/CONFIRM plus three or more years in ENDORSE).
Throughout the study period, the ARR remained low in patients who received continuous treatment with TECFIDERA compared to those who initially received two years of placebo in DEFINE/CONFIRM. In patients who switched from placebo in DEFINE/CONFIRM to TECFIDERA in ENDORSE, improvements were observed in ARR whether they were treatment-naïve or had treated their MS with IFN or GA.
Treatment-naïve patients:
Patients receiving five years of TECFIDERA (n=267): ARR was 0.123 (95% confidence interval [CI]: 0.097, 0.157)
Patients who switched to TECFIDERA in year three (n=133): ARR was 0.207 (95% CI: 0.152, 0.283)
Patients treated with one or more prior IFN/GA therapy:
Patients receiving five years of TECFIDERA (n=124): ARR was 0.195 (95% CI: 0.151, 0.252)
Patients who switched to TECFIDERA in year three (n=68): ARR was 0.253 (95% CI: 0.181, 0.353)
The safety profile of TECFIDERA observed in ENDORSE in the presented analysis was consistent with the favorable findings reported in the DEFINE and CONFIRM studies, reflecting a minimum of five years of observation. There was no overall increased risk for serious infections, including opportunistic infections.
These data will be presented in poster presentations on Thursday, April 23 at 2:00 p.m. ET:
Long-Term Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis According to Prior Therapy: Integrated Analysis of the DEFINE, CONFIRM, and ENDORSE Studies (poster P7.229)
Clinical Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Relapsing-Remitting Multiple Sclerosis Patients with Highly Active Disease: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies (poster P7.228)
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