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About EXTAVIA

Confidence in a therapy with proven efficacy

In clinically isolated syndrome (CIS), EXTAVIA is proven effective in delaying the second exacerbation

EXTAVIA is proven effective in delaying the second exacerbation
EXTAVIA is proven effective in delaying the second exacerbation

Results from the Betaseron® (interferon beta-1b) BENEFIT Study, a 2-year, multicenter, randomized, double-blind, placebo-controlled trial in patients who had recently experienced an isolated demyelinating event suggestive of MS CIS. The primary end point was time to the development of a second clinical exacerbation. Secondary end points were brain MRI measures. Patients received either interferon beta-1b (0.25 mg every other day) or placebo (N=468).1

*By proportional hazards regression adjusted for age/sex/steroids/T2-lesions/Gd-lesions.3

72% of patients did not experience a second exacerbation
72% of patients did not experience a second exacerbation

of interferon beta-1b patients

with clinically isolated syndrome (CIS) did not experience a second exacerbation at year 22

92% of patients completed the 2-year study
92% of patients completed the 2-year study

of patients

randomized to interferon beta-1b completed the 2-year study2

EXTAVIA is effective in relapsing-remitting MS

EXTAVIA is effective in relapsing-remitting MS
EXTAVIA is effective in relapsing-remitting MS

Results from the Betaseron® IFNB Study, a 2-year, double-blind, multicenter, randomized, parallel placebo-controlled clinical trial in patients with RRMS. Patients were randomized to interferon beta-1b (0.05 mg every other day), interferon beta-1b (0.25 mg every other day), or placebo. Results shown here compare the interferon beta-1b 0.25 mg arm with the placebo arm. The primary end points were the frequency of exacerbations per patient and the proportion of exacerbation-free patients. A number of secondary clinical and MRI measures were also employed, including prolongation of median time to first exacerbation. (N=372)1

31% reduction in annualized exacerbation rate
31% reduction in annualized exacerbation rate

reduction

in annualized exacerbation rate1 (p=0.0001)

25% of patients taking interferon beta-1b remained exacerbation free
25% of patients taking interferon beta-1b remained exacerbation free

of patients taking interferon beta-1b

0.25 mg remained exacerbation free vs 16% of placebo patients1 (p=0.094)

Interferon beta-1b 0.25 mg vs placebo (secondary end points):

  • 51% reduction in rate of moderate or severe exacerbations per year1 (p=0.001)
  • 80% increase in median time to first exacerbation1 (p=0.010)
  • 75% reduction of newly active MRI lesions3 (p=0.0026)
  • 83% reduction in median number of T2 active lesions3 (p=0.0089)

The exact relationship between MRI findings and the clinical status of patients is unknown. Changes in lesion area often do not correlate with changes in disability progression. The prognostic significance of the MRI findings in this study has not been evaluated.

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References:
1. Extavia [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Betaseron [Prescribing Information]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc; 2016. 3. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249. 4. Fingertip Formulary®. Analytics report. Extavia: Percentage of covered lives. Accessed October 2017.