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New Insights into Current MS Treatment NMSS 20th Annual Research Symposium Robert Shin, MD Maryland Center for MS Impact of MS Leading non-traumatic cause of disability in young adults 250,000 to 350,000 affected in US* National cost of nearly $10 billion per year* MS treatment 1990

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new insights into current ms treatment

New Insights intoCurrent MS Treatment

NMSS 20th Annual Research Symposium

Robert Shin, MD

Maryland Center for MS

impact of ms
Impact of MS
  • Leading non-traumatic cause of disability in young adults
  • 250,000 to 350,000 affected in US*
  • National cost of nearly $10 billion per year*
ms treatment 2000
MS treatment 2000
  • Betaseron
  • Avonex
  • Copaxone
ms treatment 2005
MS treatment 2005
  • Betaseron
  • Avonex
  • Copaxone
  • Rebif
  • Novantrone
  • Tysabri
ms relapse rates
MS relapse rates

-33%

-29%

-34%

-18%

-66%

-54%

current ms treatment
Current MS treatment
  • Long-term efficacy
  • Safety/Tolerability
  • Early treatment
  • Head-to-head comparisons
long term efficacy12
Long-term efficacy
  • Ideally demonstrated by long term, controlled, comparative trials
  • Such studies are impractical and possibly unethical
extension studies
Extension studies
  • PRISMS-4 (Rebif)
    • 7 to 8 years
    • Relapse rate 1.02 (crossover) vs 0.72 (44mcg)
    • Disability progression delayed by 18 months
  • CHAMPS/CHAMPIONS (Avonex)
    • 5 years (extended to 10 years)
    • 44% reduction in CDMS at 1.5 years
    • 43% reduction in CDMS at 5 years
long term follow up
Long-term follow up
  • Copaxone at 10 years
    • 108 on Copaxone therapy
    • 47 patients withdrew but were followed
    • 77 patients lost to follow up
    • 92% still walking without assistance
long term follow up15
Long-term follow up
  • Copaxone at 26* years
    • 46 followed
    • 28 patients withdrew
    • Average follow-up 10.5 years
    • 26.7% required assistance to walk
long term follow up16
Long-term follow up
  • Betaseron at 16 years
    • Identified 331/372 original patients
    • 51% (treated) vs 45% (placebo) ambulatory
    • 95% (treated) vs 83% (placebo) alive
long term follow up17
Long-term follow up
  • Avonex at 8 years
    • 160 patients, at least 2 years of Avonex
    • Sustained disability at 6 months predicted disability at 8 years
    • 67% required assistance vs 24%
neutralizing antibodies
Neutralizing antibodies
  • Protein or peptide based therapies may lead to the production of antibodies
  • When antibodies block the biologic effect of the protein/peptide they are referred to as “neutralizing antibodies” (NAbs)
nabs to beta interferon
NAbs to beta interferon
  • Betaseron (beta interferon 1b)
    • 28% to 47%
  • Rebif (beta interferon 1a)
    • 13% to 24%
  • Avonex (beta interferon 1a)
    • 2% to 6%
nabs to beta interferon20
NAbs to beta interferon
  • Typically appear within 3 to 18 months of initiation of treatment
  • Reduction in efficacy may be delayed
    • Increased relapses
    • Increased MRI disease burden
  • NAbs may disappear over time?
conclusions
Conclusions
  • Both beta interferon and glatiramer may be effective even after 5 to 15 years of treatment
  • Neutralizing antibodies may appear in a minority of patients taking beta interferon
safety issues beta interferon
Safety issues: beta interferon
  • Depression/suicidal ideation
  • Leukopenia/thrombocytopenia
  • Liver enzyme elevation/hepatic injury
  • Thyroid dysfunction
  • Pregnancy category C
safety issues beta interferon24
Safety issues: beta interferon
  • CBC and liver panel
  • Thyroid function tests
  • Monitor for depression
rebif new formulation rnf
Rebif new formulation (RNF)
  • Human serum albumin-free
  • Fetal bovine serum-free
  • Reduced injection site reactions
    • 30.8% vs 85.8%
  • Increase in flu-like side effects
    • 71% vs 48%
conclusions27
Conclusions
  • Beta interferon and glatiramer are generally well-tolerated
damage occurs early in ms
Damage occurs early in MS
  • Loss of N-acetylaspartate (NAA)
  • Diffusion tensor imaging (DTI) changes
  • White and gray matter magnetization transfer ratio (MTR) abnormalities
  • Cerebral atrophy
  • Time is brain!
ms treatments
MS treatments
  • Reduce relapse rate
  • Reduce disability
  • Reduce new/active MRI lesions
  • Earlier treatment is better!
clinically isolated syndrome cis
Clinically Isolated Syndrome (CIS)
  • A single episode of neurologic dysfunction caused by a single demyelinating lesion
  • Optic neuritis
  • Brainstem syndrome
  • Spinal cord syndrome
cis and mri
CIS and MRI
  • Patients with CIS are at increased risk to develop MS in the future
  • An abnormal MRI is associated with a greatly increased risk to develop MS in the future
question
Question
  • Can MS treatments benefit patients with CIS?
ms medications for cis
MS medications for CIS
  • ETOMS (Early Treatment of MS)
  • CHAMPS (Controlled High-risk Avonex MS Prevention Study)
  • BENEFIT (Betaseron in Newly Emerging MS For Initial Treatment)
  • PreCISe*
ms medications for cis35
MS medications for CIS
  • Randomized controlled trials consistently show fewer relapses among CIS patients treated with DMT
  • Avonex and Betaseron now carry FDA indications for treatment of CIS
conclusions36
Conclusions
  • Early treatment of MS is preferable to a delay in treatment
  • CIS may be the first occurrence of MS
  • MS treatments can be considered in CIS
need for direct comparison
Need for direct comparison
  • Different studies should not be compared to each other
  • Different inclusion/exclusion criteria
  • Different outcome measures
  • Different populations
ms relapse rates39
MS relapse rates

-33%

-29%

-34%

-18%

-66%

-54%

beta interferons
Beta interferons
  • Betaseron (beta interferon 1b)
  • Avonex (beta interferon 1a)
  • Rebif (beta interferon 1a)
incomin
INCOMIN
  • Beta interferon
    • Betaseron vs Avonex
  • 188 patients followed for 2 years
  • Betaseron 42% more likely to be relapse-free
    • 51% (Betaseron) vs 36% (Avonex)
  • Betaseon more likely to be free of MRI activity
    • 55% (Betaseron) vs 26% (Avonex)
evidence
EVIDENCE
  • Beta interferon 1a
    • 44 mcg tiw (Rebif) vs 30 mcg weekly (Avonex)
  • 677 patients followed for 48 weeks
  • 27% fewer relapses in Rebif group
  • One third reduction in MRI activity
interferon vs glatiramer
Interferon vs glatiramer?
  • Rebif vs Copaxone
  • Almost 800 patients randomized
  • Followed for 96 weeks
  • No significant difference*
interferon vs glatiramer44
Interferon vs glatiramer?
  • CombiRX
    • Copaxone + Avonex
    • Copaxone + placebo
    • Avonex + placebo
  • Is Copaxone + Avonex superior to either drug alone?
conclusions45
Conclusions
  • Higher dose, higher frequence beta interferon appears to be more effective than lower dose interferon
  • We do not know whether beta interferon or glatiramer acetate is more effective
summary
Summary
  • There have been great advances in treating MS over the past 15 years
  • Clinical research has been crucial in helping us better understand and refine MS treatment