Biogen Releases Update on Multiple Sclerosis Therapies Profile

April 22, 2021 - Biogen recently announced new data from its portfolio of multiple sclerosis (MS) therapies.

The updates include data on quality of life benefits and findings from analyses on extended interval dosing with Tysabri, a prescription medicine used to treat relapsing forms of MS. Additionally, Biogen released new real-world experience data from Vumerity, an oral fumarate that is approved in the US for the treatment of relapsing forms of MS.  

“With chronic conditions like MS, where every patient has a different experience with the disease, it is critically important to understand how treatment impacts their daily living and quality of life,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said in the announcement. 

Biogen researchers found that in individuals with baseline impairment who were treated with Tysabri or another MS treatment, Ocrevus, statistically significant improvements were seen in 10 to 12 and 8 to 12 Neuro-Qol domains, respectively. 

Additionally, in 10 to 12 domains of the Neuro-QoL questionnaire, the adjusted annualized rate of improvement was greater with Tysabri as compared to Ocrevus. 

Neuro-Qol is a measurement that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions.

Overall, the difference between the therapies was statistically significant in favor of Tysabri in three domains, including satisfaction with social roles and activities, participation in social roles and activities, and emotional and behavioral dyscontrol. 

In neurology, there are no blood tests or numbers to carefully monitor disease progression beyond diagnosis. 

Therefore, Biogen established the MS Paths network to foster collaboration between MS centers in the EU and the US. The collaboration helps to transform patient care by generating standardized data from a diverse, real-world patient population, the company explained.  

In a recent analysis, MS Paths researchers found that patients receiving either extended interval dosing or standard interval dosing had comparable real-world effectiveness on quantitative magnetic resonance imaging outcomes.

Specifically, extended interval dosing was associated with a notable 88 percent reduction in the risk of progressive multifocal leukoencephalopathy in comparison to the approved dosage of every four weeks.

The data included more patients followed for a longer period and with greater exposers, a Biogen spokesperson explained. This reinforces results from earlier analyses of extended interval dosing. 

Results from two new analyses investigating extended interval dosing with Tysabri may help further inform the drug’s benefit-risk profile, the company said. 

Biogen will also continue to evaluate the efficacy, safety, and tolerability of extended interval dosing of Tysabri through the prospective NOVA trial, with initial results expected in 2021.

Additionally, Biogen’s new findings on the use of Vumerity in a real-world setting reinforced the benefits of improved gastrointestinal tolerability. Researchers also confirmed that experience in clinical trials is consistent with clinical practice.

Data collected from December 2019 to August 2020 showed that out of 160 patients with relapsing MS, about 88.6 percent were still on therapy at the end of the analysis. And 91.4 percent of patients had a high adherence rate.

Treatment discontinuation rate due to gastrointestinal side effects was just 3.8 percent.

“These data show that the benefits TYSABRI provides in terms of a patient’s quality of life are substantial and that the positive gastrointestinal tolerability profile of VUMERITY can help people with relapsing MS continue with treatment, which is essential to delay its progression,” Radhakrishnan continued. 

Biogen’s updates are part of its ongoing commitment to improve overall understanding of MS and advance treatment through innovation. 

Additional trial outcomes expected to be reported later this year include the impact of Tysabri on quality of life in a real-world cohort of patients with MS, outcomes of Tysabri in patients on extended interval dosing compared with standard interval dosing, and MS patients treated with diroxiel fumarate in the real-world setting.