New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis - Seite 2

• In people treated with TYSABRI or Ocrevus (ocrelizumab) with baseline impairment, statistically significant improvements were seen in 10 of 12 and 8 of 12 Neuro-QoL domains, respectively. In 11 of 12 domains on the Neuro-QoL questionnaire, the adjusted annualized rate of improvement was greater with TYSABRI as compared to Ocrevus.
• The difference between the two therapies was statistically significant in favor of TYSABRI in three of the domains: satisfaction with social roles and activities (p=0.02), participation in social roles and activities (p=0.0001) and emotional and behavioral dyscontrol (p=0.01).

Neuro-QoL is an independently validated set of patient-reported outcome measurements that assess the physical, mental and social effects of people living with neurological conditions such as MS. Biogen established the MS PATHS network to foster collaboration between leading MS centers in Europe and the U.S. to help transform patient care by generating standardized data from a diverse, real-world patient population.

Additionally, results from two new analyses investigating EID with natalizumab may help further inform the drug’s benefit-risk profile. Biogen continues to evaluate the efficacy, safety and tolerability of natalizumab EID through the prospective NOVA trial (NCT03689972) with initial results expected in 2021.

• From an analysis of data in MS PATHS, natalizumab patients receiving either EID or Standard Interval Dosing (SID) had comparable real-world effectiveness on quantitative magnetic resonance imaging (MRI) outcomes (p>0.05 for all MRI outcomes).
• An updated analysis of data from the TOUCH Prescribing Program demonstrated in the primary analysis that EID is associated with a significant (P<0.0001) 88% reduction in the risk of progressive multifocal leukoencephalopathy (PML) in comparison to the approved every four-week dose. The data, which included more patients followed for a longer period and with slightly greater exposures, reinforces results from earlier analyses of EID.

Data Confirm Positive Gastrointestinal Tolerability Profile With VUMERITY in Real-World Setting
New findings on the use of VUMERITY in a real-world setting reinforce the benefits of improved gastrointestinal (GI) tolerability and confirm that the experience in clinical trials is consistent with clinical practice. In a retrospective analysis of data from December 2019 to August 2020 of 160 patients with relapsing MS, the treatment discontinuation rate due to GI side effects was low (3.8%) with 88.6% estimated to still be on therapy at the end of analysis and a high rate of adherence (91.4%). In a subgroup of patients who switched from TECFIDERA (dimethyl fumarate) to VUMERITY, the majority of patients switched as a result of gastrointestinal tolerability with most remaining on therapy (92.3%).