Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) data demonstrate improved outcomes with early MS treatment

101

Biogen has announced new real-world data that show treatment with its multiple sclerosis (MS) therapies, Tecfidera (dimethyl fumarate) and Tysabri (natalizumab), early in the course of the disease may improve outcomes for people living with relapsing-remitting MS. These data were presented at the 69th annual meeting of the American Academy of Neurology (AAN; 22–28 April, Boston, USA).

MS is a chronic, often disabling disease that attacks and causes inflammation within the central nervous system. Initiating an appropriate disease modifying therapy (DMT) soon after diagnosis has been shown to slow the physical and cognitive decline associated with MS and may prevent the accumulation of future disability, allowing people living with MS to stay active longer.

A retrospective real-world study provides further comparison of the impact of dimethyl fumarate on risk of relapse relative to other oral MS therapies. Researchers used US insurance claims data to compare the risk of relapse among patients initiating dimethyl fumarate (n=5,600) versus fingolimod (n=1,110) or teriflunomide (n=795). These results show that dimethyl fumarate significantly reduced the risk of relapse by 30% compared to teriflunomide (hazard ratio [HR]: 1.302; p<0.01) in patients with no DMT exposure in the year prior to the study and those treated with a DMT in the year prior to the study, and had comparable efficacy to fingolimod (HR: 0.995; p=0.94). These data are consistent with other real-world comparative effectiveness data showing similar annualised relapse rate (ARR) and risk of relapse compared to fingolimod and greater efficacy in these measurements compared to teriflunomide, interferon beta and glatiramer acetate. 

A post-hoc, subgroup analyses of the open-label studies PROTEC and RESPOND assessed dimethyl fumarate in newly diagnosed MS and early switch patients, respectively. Results show that dimethyl fumarate significantly reduced the ARR over one year in patients diagnosed ≤1 year prior to study entry and naïve to MS approved therapies (unadjusted ARR after 12-months of treatment was 0.18 (95% confidence interval [CI]: 0.13, 0.26) compared to 1.13 (n=184, 95% CI: 1.04, 1.23) 12-months prior to treatment initiation), as well as those who switched to dimethyl fumarate from glatiramer acetate (a 78% reduction was demonstrated 12-months following switch to dimethyl fumarate [n=231, 0.11, 95% CI: 0.06, 0.18], versus 12-months prior to switch [0.48, 95% CI: 0.40, 0.58]).

Further, new data from the Tysabri  Observational Program (TOP), a 10-year real-world study into the effects of natalizumab on patient groups according to time since symptom onset, demonstrate that early and continued treatment leads to better clinical outcomes.

A subgroup analysis from TOP compared outcomes for treatment-naive patients who began taking natalizumab shortly after MS symptom onset (≤1 year, n=233) with those who initiated natalizumab after experiencing MS symptoms for some time (>1 and ≤5 years [n=179], or >5 years [n=144]). ARR and disability worsening or improvement, as measured by the Expanded Disability Status Scale (EDSS), were assessed. Results show that, over three years, the likelihood of confirmed 24-week EDSS improvement was significantly greater for patients treated with natalizumab within one year of MS symptom onset (49.3%), than for those treated between one to five years (38.1%, p=0.0212) or more than five years (26.3%, p=0.0029) following symptom onset. ARR was significantly reduced over a three year period with natalizumab compared with the year prior to natalizumab treatment in all three cohorts (92.6%–92.8%; p<0.0001).

Additional TOP data presented at the AAN meeting show patients who continued natalizumab treatment experienced better clinical outcomes than those who switched to another therapy.