#ECTRIMS2018 — Biogen’s MS Treatments Found Safe, Effective in Clinical and Real-world Data

Clinical data and real-world results support the long-term efficacy of Biogen’s medications for multiple sclerosis (MS), according to scientific presentations being released by the company.

Specifically, findings support the effectiveness of Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) used early in the disease’s course, as well as the safety of Avonex (interferon-beta 1a), and Plegridy (peginterferon beta-1a) in pregnancy.

Biogen will also present data showing the potential utility of serum neurofilament light (sNfL) as a biomarker of MS disease activity and as a tool for monitoring treatment. Updates on ways to improve assessing changes in cognition and other crucial MS outcomes through Biogen-sponsored MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions) will also be shared.

The company will hold more than 70 oral and poster presentations on its MS medications and research efforts to improve patient care at the 34^th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place Oct. 10-12 in Berlin.

“Biogen believes the need for finding new approaches to treat MS is as important as ever,” Michael Ehlers, MD, PhD, Biogen’s executive vice president of research and development, said in a press release. Ehlers added that the research being presented at ECTRIMS reflects the company’s “proven track record of developing innovative medicines for MS,” as well as its pursuit of “new clinical approaches aimed at generating data that will encourage more individualized treatment decisions to help meet the needs of people living with MS today and into the future.”

 Among four presentations on Tecfidera, results from the long-running Phase 3 ENDORSE trial (NCT00835770) showed that treatment of newly diagnosed relapsing-remitting MS patients was associated with low annualized relapse rates — the number of confirmed relapses per year. Most patients remained free of confirmed disability progression, including some treated for up to nine years.

This will be the subject of “P920 – Delayed-release Dimethyl Fumarate Demonstrates Sustained Efficacy over Nine Years in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis,” to be presented on Thursday afternoon.

The ongoing five-year, real-world ESTEEM study (NCT02047097) showed similar benefits in RRMS patients treated with Tecfidera early in their disease course. The presentation “P595 – Real-world efficacy of delayed-release dimethyl fumarate in early multiple sclerosis: interim results from ESTEEM” will cover these results on Wednesday. ESTEEM, an observational study of people in clinical care, is still enrolling patients; details are available here.

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New safety results for Tecfidera will be the subject of two poster presentations. Among most patients experiencing lymphopenia (low lymphocyte levels in the blood) while on treatment, meaningful lymphocyte reconstitution — or increased levels — occurred after stopping Tecfidera for three months. According to Biogen, this reinforces the importance of monitoring absolute lymphocyte counts as mentioned on the product’s label.

Biogen will also present data showing Tysabri’s effectiveness over 10 years, especially in patients being treated earlier in their disease course. Safety results were consistent with the medication’s well-established safety profile, with no new concerns being identified. These were the findings of the TYSABRI Observational Program (TOP; NCT00493298), which is the largest ongoing, real-world study of Tysabri-treated patients. It, too, is still recruiting participants, and more information can be found here.

The presentation, “Real-world Data from Over 10 years in the TYSABRI Observational Program: Long-term Safety and Effectiveness of Natalizumab in Relapsing-remitting Multiple Sclerosis Patients,” will cover TOP’s results on Thursday afternoon.

Biogen will also show results from the European Interferon Beta Pregnancy Registry and Nordic EPID MS Pregnancy Study (NCT02749396), which demonstrated that treatment with interferon beta formulations — including Plegridy and Avonex — before conception or during pregnancy did not affect outcomes for the pregnancy or for the infant. “P1753 – Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and Population Based Registries in Finland and Sweden” will be presented on Friday.

Two other presentations will show the efficacy of Plegridy based on results from the Phase 3 trials ADVANCE (NCT00906399) and CONFIRM (NCT00451451). Data from the ADVANCE study found treatment lowered the risk of chronic “black holes” evolving from acute lesions, as seen using magnetic resonance imaging, and CONFIRM showed Plegridy-treated patients had better clinical outcomes compared with Copaxone (glatiramer acetate, by Teva Pharmaceuticals).

Company researchers will also discuss the current opportunities and paths to bring sNfL into MS clinical practice. New results from MS PATHS will detail cognitive changes, and show the importance of clinically meaningful benchmarks of disease progression on patients’ daily lives. MS PATHS is a collaboration involving 10 MS centers in the U.S. and Europe that are producing real-world data at the point-of-care to promote personalized treatment.

For more details on Biogen’s presentations at ECTRIMS, please click here.