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This excerpt taken from the ELN 20-F filed Mar 30, 2006. AFFIRM
Phase 3 Monotherapy Trial
The AFFIRM trial was a two-year, randomized, multi-center,
placebo-controlled, double-blind study of 942 patients
conducted in 99 sites worldwide, evaluating the effect of
Tysabri on the progression of disability in MS at two
years and the rate of clinical relapses at one and two years.
Patients with relapsing forms of MS, who had experienced at
least one relapse in the previous year, were randomized to
receive a 300 milligram intravenous (300 mg IV) infusion of
Tysabri (n= 627) or placebo (n=315) every four weeks.
At one year, there was a 66 percent relapse rate reduction
in the Tysabri-treated group versus the placebo-treated
group. An annualized relapse rate of 0.25 was seen with
Tysabri-treated patients versus 0.74 with placebo-treated
patients.
Table of Contents
All secondary endpoints were also met. In the
Tysabri-treated group, 60 percent of patients
developed no new or newly enlarging T2 hyperintense lesions
compared to 22 percent of placebo-treated patients. On the
one-year MRI scan, 96 percent of Tysabri-treated
patients had no gadolinium enhancing lesions compared to
68 percent of placebo-treated patients. The proportion of
patients who remained relapse free was 76 percent in the
Tysabri-treated group compared to 53 percent in the
placebo-treated group.
In February 2005, we and Biogen Idec announced that the AFFIRM
monotherapy trial achieved the two-year primary endpoint of
slowing the progression of disability in patients with relapsing
forms of MS. Tysabri treatment led to a 42 percent
reduction in the risk of disability progression relative to
placebo. These data also demonstrated a 67 percent
reduction in the rate of clinical relapses over two years, which
was sustained and consistent with the previously reported
one-year results.
In April 2005, the full two-year AFFIRM monotherapy data was
presented at the 57th annual American Academy of Neurology
meeting. The data was published in the New England Journal of
Medicine in March 2006.
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