ECTRIMS 2016: Biogen Presents New TECFIDERA Data - Drug Discovery and Development

New real-world and clinical evidence demonstrates that TECFIDERA (dimethyl fumarate) consistently delivered strong, sustained efficacy in newly-diagnosed and previously treated patients with relapsing-remitting multiple sclerosis (RRMS) and affirms its well-characterized safety profile in patients who have had up to nine years of treatment. Biogen (NASDAQ: BIIB) will present these data at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London.

“As we continue to gather both clinical and real-world data, evidence shows that TECFIDERA consistently demonstrates strong efficacy in reducing MS disease activity over the long term,” said Ralph Kern, M.D., senior vice president, Worldwide Medical, Biogen. “The findings presented at ECTRIMS confirm the results we observed in the TECFIDERA clinical trial program, further supporting its early use to improve outcomes for people living with MS.”

Comparative Real-World Data Echo Strong Efficacy of TECFIDERA Observed in Clinical Trials
Real-world evidence affirms the positive effects of TECFIDERA treatment observed in clinical trials, and demonstrates effectiveness versus multiple MS therapies.

Using data sourced from the global MSBase registry and propensity score matching, researchers compared relapse rates and discontinuation outcomes in 415 TECFIDERA-treated patients to those treated with another widely-used disease-modifying therapy (fingolimod, teriflunomide, interferon β and glatiramer acetate). MSBase is an ongoing, longitudinal, observational registry that includes data from nearly 40,000 MS patients across 72 countries.

Real-world evidence from the MSBase analysis shows significant benefits with TECFIDERA on time to first relapse relative to interferon β (26%; hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.57, 0.97), glatiramer acetate (28%; HR 0.72; 95% CI 0.54, 0.95) and teriflunomide (34%; HR 0.66; 95% CI 0.45, 0.99). Time to first relapse between TECFIDERA and fingolimod was similar.

“The MSBase registry is one of the largest sources of real-world data, contributed by physicians with the ultimate goal of improving MS quality of care,” said professor Helmut Butzkueven, joint director of the Multiple Sclerosis Service at the Royal Melbourne Hospital and associate professor in the Department of Medicine, University of Melbourne. “When we conducted this comparative effectiveness research, propensity score matching helped ensure the similarity of the patient populations, which strengthened the analysis. The data showed that TECFIDERA significantly reduced the time to first relapse compared to platform therapies and teriflunomide and had comparable efficacy to fingolimod.”

The MSBase analysis also evaluated two secondary endpoints, annualized relapse rate (ARR) and treatment persistence. Longer follow-up of TECFIDERA in the real-world setting will strengthen this analysis and may clarify the effects seen on ARR across treatment groups. An increase of treatment discontinuation with TECFIDERA relative to fingolimod and interferon was also observed. A separate real-world retrospective analysis of TECFIDERA patients presented at ECTRIMS suggests that providing patient coaching can offer a potentially effective means to reduce treatment discontinuations.

Additional efficacy data presented at ECTRIMS include:

New U.S. health claims data from a large commercial insurance database, which demonstrate the real-world effectiveness of TECFIDERA compared to other MS therapies, as supported by the MSBase registry. A new analysis of these data also shows consistent results in a subgroup of newly-diagnosed patients.
Data from the ongoing Phase 3 ENDORSE study that show the ARR and 24-week confirmed disability progression remained low in newly-diagnosed patients treated with TECFIDERA over a minimum of seven years.

Favorable Benefit-Risk Profile Strengthened by Nine Years of Treatment Data
The safety profile of TECFIDERA remains unchanged and the overall benefit-risk remains favorable, as demonstrated by up to nine years of clinical study results and real-world evidence presented at the congress. Further, the data continue to substantiate current guidance for monitoring absolute lymphocyte counts (ALC) to effectively identify patients at risk of severe and prolonged lymphopenia.