Biogen Inc. announced new data from its portfolio of multiple sclerosis (MS) therapies being presented at the American Academy of Neurology (AAN) 2022 Annual Meeting. The presentations include new real-world, long-term data on TYSABRI® (natalizumab), as well as persistence and adherence learnings with VUMERITY® (diroximel fumarate). Additional presentations highlight the use of digital tools to potentially predict MS disease progression.

These data build on ongoing work to advance the understanding and treatment of serious neurological and neurodegenerative diseases, and highlight Biogen's commitment to science that strives to address the diverse needs of people living with MS. Two presentations contribute to the understanding of extended interval dosing (EID) with intravenous (IV) natalizumab in real-world and clinical trial settings. An updated analysis of the U.S. TOUCH® (TYSABRI Outreach: Unified Commitment to Health) database as of June 30, 2021, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing. In the updated analysis, which included more patients and longer exposures, EID was associated with a significant 87% reduction (hazard ratio 0.127; P<0.0001) in the probability of PML in comparison to the approved Q4W dose.

Primary results from the Phase 3b NOVA study of every six-week (Q6W) IV dosing with natalizumab were also presented during a platform session, showing that Q6W administration of natalizumab maintains control of MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. Topline data were first reported in August 2021, and additional results were shared at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual congress last year. The approved dose of TYSABRI is 300mg on a Q4W dosing regimen.

In addition to the data presented on Q6W IV dosing with natalizumab, a new analysis of the observational STRIVE study using the approved Q4W IV TYSABRI dosing schedule found that treatment-naïve patients with early relapsing-remitting multiple sclerosis (RRMS) had improved clinical outcomes in comparison with patients who had received prior disease-modifying therapies (DMTs). These findings provide useful information on the added clinical benefit that initiating treatment early in the disease course with TYSABRI may provide. At four years, the cumulative probability of 24-week confirmed disability worsening (CDW) was significantly lower in treatment-naïve patients than in patients with prior DMT treatment (11.5% vs 29.0%; P=0.0015).

In the treatment of MS, high levels of adherence and persistence with DMTs are associated with improved clinical outcomes and reduced treatment costs.1 Two claims analyses from AcariaHealth Specialty Pharmacy Program and Optum showed high rates of persistence and adherence with VUMERITY, consistent with clinical trial experience and further supporting VUMERITY as a well-tolerated oral fumarate option due to its gastrointestinal (GI) tolerability profile. A retrospective analysis of the AcariaHealth Specialty Pharmacy Program included 1,143 patients who initiated therapy with VUMERITY between Dec. 1, 2019, and Jan.

30, 2021. Persistence as measured by the overall estimated proportion of patients remaining on VUMERITY at 16 months was 82.3%; 4.5% discontinued VUMERITY due to GI side effects. Adherence, as measured by proportion of days covered (PDC), was 90.8%, and 85.4% of patients achieved a PDC =80%.

Consistent findings were also observed in a subgroup of 433 patients who switched from TECFIDERA® (dimethyl fumarate) to VUMERITY. An Optum claims analysis included 1,885 patients with at least one MS-related claim between Oct. 1, 2019, and March 31, 2021: 224 were treated with VUMERITY, 746 with TECFIDERA, 601 with teriflunomide, 182 with fingolimod and 132 with siponimod.

Persistence and adherence rates for VUMERITY after 90 days were 84% and 88%, respectively, consistent with or higher than those for other DMTs; 79% of patients achieved a PDC =80%.