Data publicerade på AAN visar att Biogens MS-portfölj har positiv effekt på MS-patienters liv
- New findings from MS PATHS show that treatment with TYSABRI®(natalizumab) can lead to improvements in mental and social health compared to Ocrevus® (ocrelizumab)
- Real-world data from VUMERITY® (diroximel fumarate) reinforce the treatment’s gastrointestinal tolerability profile
- Biogen including new information on the clinical profile of extended interval dosing with natalizumab
Biogen announced new data from its portfolio of multiple sclerosis (MS) therapies to be presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, April 17-22. The presentations include data on quality of life and analyses of extended interval dosing (EID) with NATALIZUMAB as well as new real-world experience data from DIROXIMEL FUMARATE. The research adds to the vast clinical knowledge Biogen as part of its commitment to the care of people living with MS.
Analyses Demonstrate Improved Quality of Life Outcomes with NATALIZUMAB and Further Evaluate Extended Interval Dosing
To better understand clinically meaningful quality of life parameters following treatment with NATALIZUMAB, MS PATHS (Partners Advancing Technology and Health Solutions) researchers analyzed patient reported data on 12 different domains on the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire such as sleep disturbance, anxiety, fatigue, depression and participation in daily activities. Results included:
- In people treated with NATALIZUMAB or ocrelizumab with baseline impairment, statistically significant improvements were seen in 10 of 12 and 8 of 12 Neuro-QoL domains, respectively.
- The difference between the two therapies was statistically significant in favor of NATALIZUMAB 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.
