ECTRIMS Congress 2013
Biogen
Idec BIIB -5.03% today announced results from several new analyses of
TYSABRI(R) (natalizumab) data that demonstrate its effectiveness in
reducing multiple sclerosis (MS) disease activity. This effect was
particularly significant in people with relapsing MS who initiated
treatment when they had lower Expanded Disability Status Scale (EDSS)
scores as well as in those who have been treated for more than two
years. These data will be presented at the 29th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Copenhagen, Denmark from 2-5 October.
"These analyses build upon
a growing body of evidence that demonstrates greater clinical benefits
for people with MS when TYSABRI is initiated earlier in the course of
the disease, as well as when TYSABRI is used for a longer duration in
appropriate patients," said Alfred Sandrock, M.D., Ph.D., group senior
vice president, Development Sciences and Chief Medical Officer, Biogen
Idec.
More Patients Demonstrated No Evidence of Clinical or MRI Disease Activity with Earlier TYSABRI Use
AFFIRM
was a two-year, randomized, multi-center, placebo-controlled,
double-blind study of 942 patients evaluating the effect of TYSABRI on
the rate of clinical relapses and the progression of disability as
measured by at least a one-point worsening in EDSS score sustained for
three months.
A post-hoc analysis of AFFIRM was
undertaken to
determine which baseline characteristics were associated with patients
showing no evidence of clinical or MRI disease activity (defined as no
relapse, no 12-week sustained EDSS progression, and no
gadolinium-enhancing [Gd+] or new/enlarging T2-hyperintense lesions) at
two years. A greater proportion of TYSABRI patients were found to have
no evidence of clinical or MRI disease activity compared to those on
placebo in all sub-groups analyzed with the beneficial effect being
significantly greater in patients with an EDSS score of <3
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Fewer and Less-Severe Relapses with TYSABRI
An
additional sub-analysis of AFFIRM assessed the effectiveness of TYSABRI
on reducing relapse severity and recovery from relapse compared to
placebo. Observations from this sub-analysis showed that patients
treated with TYSABRI experienced less-severe relapses, as measured by
EDSS score changes during the relapse and residual deficits following
relapse.
These data will be presented in the poster session
titled, "Immunomodulation/Immunosuppression," on Friday, 4 October at
3:45 p.m. - 5:00 p.m. CET:
-- Effects of natalizumab treatment on freedom from disease activity by baseline characteristics in AFFIRM (poster 519)
--
Natalizumab reduces the disabling amplitude of multiple sclerosis
relapses and improves post-relapse residual disability (poster 524)
Clinical Benefit of TYSABRI Improves Beyond Two Years of Treatment
An
analysis of data from the TYSABRI Observational Program (TOP), an
ongoing observational, open-label, 10-year prospective study of
relapsing-remitting MS (RRMS) patients, assessed patients who have been
treated with TYSABRI for at least four years. The analysis found that
patients with less disability at baseline (EDSS score of <3
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"TYSABRI has advanced the
treatment of RRMS patients with its established efficacy," Sandrock
added. "This analysis is encouraging because it provides new insight
into the use of TYSABRI beyond two years and suggests that effects of
treatment are even better with longer use in appropriate patients."
These
data will be presented in the poster session titled, "Long-Term
Treatment Monitoring," on Friday, 4 October at 3:30 p.m. - 5:00 p.m.
CET:
-- Disease activity and disability progression decrease
beyond 2 years on natalizumab in relapsing MS patients in the TYSABRI(R)
(natalizumab) Observational Program (poster 1050)
About TYSABRI
TYSABRI
is approved in more than 65 countries. TYSABRI is approved in the
United States as a monotherapy for relapsing forms of MS, generally for
patients who have had an inadequate response to, or are unable to
tolerate, an alternative MS therapy. In the European Union, it is
approved for highly active relapsing-remitting MS (RRMS) in adult
patients who have failed to respond to beta interferon or glatiramer
acetate or have rapidly evolving, severe RRMS.
TYSABRI has
advanced the treatment of MS patients with its established efficacy.
Data from the Phase 3 AFFIRM trial, which was published in The New
England Journal of Medicine, showed that after two years, TYSABRI
treatment led to a 68 percent relative reduction (p<0
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