A Look Inside New MS Data With Biogen’s Medical Director of Clinical Development


There is a lot of anticipated excitement for multiple sclerosis treatments unveiled by Biogen at the 34th Congress of the European Committee for Treatment and Research in MS in Berlin.

During ECTRIMS, which is scheduled to end Friday, Cambridge, Mass.-based Biogen announced several key updates to its MS research at the conference, including long-term efficacy studies for Tecfidera (dimethyl fumarate) and Tysabri (natalizumab). That long-term data was something that particularly excited Bernd Kieseier, medical director of clinical development at Biogen, who spoke with BioSpace from the conference and shared his enthusiasm over the advances being made in multiple sclerosis research.

“There are so many things to be excited about… in this complex field of MS,” Kieseier said.

For Biogen particularly, the company presented data that supported the long-term use of its two leading MS drugs, Tysabri and Tecfidera. Study information Biogen presented showed that patients continue to benefit from Tysabri 10 years after beginning treatment and nine years after beginning treatment with Tecfidera. The clinical data shared, Kieseier said, is an important one for treating physicians, as well as patients.

“It’s an important message that if you treat patients for 10 years, the medications are still potent and clinically effective,” Kieseier said.

In addition to the long-term data for the two MS drugs, Biogen also presented data that supported treatment with Tysabri and Tecfidera in the early stages of disease diagnosis. Biogen’s data showed that newly diagnosed patients who were treated with Tecfidera experienced low annualized relapse rates. Additionally, the data showed that the majority of patients remained free from confirmed disability.

Kieseier also noted that the long-term data for Tysabri showed that the safety findings are consistent with the medication’s safety profile. He said that gives clinicians and prescribers the confidence to use the mediation to treat MS patients.

Not only is Biogen showing off the latest Tecfidera and Tysabri data, the company is also showcasing the safety and efficacy profiles of Plegridy (peginterferon beta-1a)‎ and Avonex (interferon beta-1a), two widely prescribed MS interferon beta treatments. One of the key findings of the latest studies of the interferons showed that exposure to interferon beta treatment, which includes the two Biogen medications, before conception and/or during pregnancy did not adversely affect pregnancy or infant outcomes.

Additionally, a subgroup analysis from a clinical study showed that Plegridy also lowered the risk of chronic black holes, or atrophy of the brain, evolving from acute MRI lesions.

Not only was he excited about the research supporting Biogen’s MS pipeline, Kieseier was also eager to talk about the potential of sNfL a biomarker for MS disease activity that has potential to be used as a treatment monitoring tool. At one time it was a difficult biomarker to measure, but Kieseier said over the years different assays have been developed that allow it to be measured.

“There’s huge excitement that this marker could become something meaningful in clinical practice, but there’s still much work to be done before that,” Kieseier said.

Kieseier said researchers will continue to conduct tests to establish norms with the biomarker. The hope is that at some point, a blood test to measure the biomarker would be able to replace an MRI scan for MS patients. He said this would be easier and could “easily change the way how we assess the disease.”

If a patient has high levels of the biomarker, physicians could choose to be more aggressive in how they might want to treat the disease. The test, should it become a norm, could allow a higher frequency of patient monitoring, he added. Such a disease monitoring tool combined with the efficacy of Biogen’s MS medications, would be beneficial weapons in the fight against the disease, Kieseier said.

“In general, we’re heavily supporting the ongoing activities around the new biomarker and will try to make this happen. It can be a game changer,” he said,

Biogen also shared results from MS PATHS to detail cognitive changes, and show the importance of clinically meaningful benchmarks of disease progression on patients’ daily lives. MS patients express cognitive decline early on, Kieseier said. The data being gathered will help with personalized treatment options, he added.

As Biogen and other researchers continue to unlock the complexities of multiple sclerosis, Kieseier said he is optimistic that they will be able to “solve many of the questions around the disease” and ultimately develop treatments that will benefit patients.


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