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Tecfidera® and Tysabri® data show improved outcomes in early MS treatment

Posted in Neurology News on 28th Apr 2017


Real-World Data Further Support Efficacy of Dimethyl Fumarate in Newly Diagnosed and Early Switch Patients

MS Patients with High Disease Activity Benefit from Early and Continued Natalizumab Treatment.

Biogen have announced new real-world data that show treatment with its leading 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) in Boston, U.S.

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.1,2

Comparative Effectiveness Data Further Support Use of Dimethyl Fumarate in Early MS

A retrospective real-world study provides further comparison of the impact of dimethyl fumarate on risk of relapse relative to other oral MS therapies.3 Researchers used U.S. 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).3 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.4  

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 years 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),5 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]).6

Early and Continued Natalizumab Treatment Leads to Better Outcomes in MS Patients with High Disease Activity

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 confirmed 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).7

Additional TOP data presented at the meeting show patients who continued natalizumab treatment experienced better clinical outcomes than those who switched to another therapy.8


  1. Kappos, L., Freedman, M., Polman, C., et al. (2007). Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: A 3-year follow-up analysis of the BENEFIT study. The Lancet, 389-397.
  2. 2.Goodin, D., & Bates, D. (2009). Review: Treatment of early multiple sclerosis: The value of treatment initiation after a first clinical episode.Multiple Sclerosis, 1175-1182.
  3. Nicholas J, et al. Comparative Effectiveness of Delayed-release Delayed dimethyl fumarate Versus Fingolimod and Teriflunomide on Risk of Relapse. American Academy of Neurology (AAN) 2017 Annual Meeting, Boston, 22-28 April 2017.
  4. Spelman T, et al.Comparative analysis of MS outcomes in delayed dimethyl fumarate-treated patients relative to propensity matched fingolimod, interferon, glatiramer acetate, or teriflunomide. P1157. The 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), London, England, 14–19 September 2016.
  5. Berger T, et al.Effectiveness of Delayed-release Delayed dimethyl fumarate on Clinical Measures and Patient-Reported Outcomes in Newly Diagnosed and Other Early Relapsing-Remitting Multiple Sclerosis Patients: Subgroup Analysis of PROTEC. American Academy of Neurology (AAN) 2017 Annual Meeting, Boston, 22-28 April 2017.
  6. Kresa-Reahl K, et al.Effectiveness of Delayed-release Delayed dimethyl fumarate on Clinical Measures and Patient-Reported Outcomes in Relapsing Multiple Sclerosis (RMS) Patients Switching After Suboptimal Response to Glatiramer Acetate, Including Patients With Early MS: Subgroup Analysis of RESPOND. American Academy of Neurology (AAN) 2017 Annual Meeting, Boston, 22-28 April 2017.
  7. Spelman T, et al.In Treatment-Naive Patients With Relapsing-Remitting Multiple Sclerosis (RRMS), Initiating Natalizumab Earlier Is Associated With Greater Disability Improvement than Delaying Treatment: Real-World Results From the TYSABRI® Observational Program (TOP). American Academy of Neurology (AAN) 2017 Annual Meeting, Boston, 22-28 April 2017.
  8. Trojano M, et al. Real-World Relapsing-Remitting Multiple Sclerosis (RRMS) Patients in the  TYSABRI®  Observational Program (TOP) Who Discontinued Natalizumab: Why They Stopped, Which Therapies They Switched To, and How Their Disease Activity Changed. American Academy of Neurology (AAN) 2017 Annual Meeting, Boston, 22-28 April 2017.